Lidocaine Topical Spray

Brand(s)
Derma Numb, Solarcaine, Unburn
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Chain Drug Consortium, Llc (2015-10-20)
Oldest Current Product
1997-10-27
License(s)
ANDA, OTC MONOGRAPH FINAL, OTC MONOGRAPH NOT FINAL
RxNORM
TOPICAL SPRAY\LIDOCAINE
FDAOB
INJECTION\INJECTION\LIDOCAINE HYDROCHLORIDE\rdfq
TOPICAL\SOLUTION\LIDOCAINE HYDROCHLORIDE
SPL Active
CUTANEOUS\SPRAY\LIDOCAINE
TOPICAL\AEROSOL, SPRAY\LIDOCAINE
TOPICAL\AEROSOL\LIDOCAINE
TOPICAL\GEL\LIDOCAINE HYDROCHLORIDE
TOPICAL\SOLUTION\LIDOCAINE HYDROCHLORIDE
TOPICAL\SPRAY, METERED\LIDOCAINE
TOPICAL\SPRAY\LIDOCAINE
TOPICAL\SPRAY\LIDOCAINE HYDROCHLORIDE
TOPICAL\SPRAY\LIDOCAINE: LIDOCAINE HYDROCHLORIDE
SPL Moiety
CUTANEOUS\SPRAY\LIDOCAINE
TOPICAL\AEROSOL, SPRAY\LIDOCAINE
TOPICAL\AEROSOL\LIDOCAINE
TOPICAL\GEL\LIDOCAINE
TOPICAL\SOLUTION\LIDOCAINE
TOPICAL\SPRAY, METERED\LIDOCAINE
TOPICAL\SPRAY\LIDOCAINE

product(s) by strength(s)

lidocaine 10 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1622170201OTC MONOGRAPH NOT FINALFruit Of The Earth, Inc.2014-09-12LIDOCAINETOPICALSPRAYaa39c75e-5efb-435b-95ab-a41cfc36e4f2

lidocaine 100 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1101880001OTC MONOGRAPH FINALAnsell Healthcare Inc2011-11-02LIDOCAINETOPICALSPRAY41a35001-aa75-4157-b81c-a34b94afc50d

lidocaine 130 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1696640001OTC MONOGRAPH FINALMomentum Management2015-05-13LIDOCAINETOPICALSPRAY2ad63160-4f6f-4970-80b6-f6d19c5660a5

lidocaine 5 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1003633107OTC MONOGRAPH NOT FINALWalgreens2013-03-15LIDOCAINETOPICALSPRAYcc8d34f0-91e0-44b7-9fe4-4c31f7d98a8d
2561040006OTC MONOGRAPH NOT FINALPremier Brands Of America Inc.2013-01-01LIDOCAINETOPICALAEROSOL, SPRAY88bf3651-4d8f-4132-92a5-674f6c7bbbd6
3597790230OTC MONOGRAPH NOT FINALCvs2014-11-11LIDOCAINETOPICALSPRAY42e75fb2-9ff8-4716-8baf-d013c181d972
4680160614OTC MONOGRAPH NOT FINALChain Drug Consortium, Llc2005-12-07LIDOCAINETOPICALAEROSOL, SPRAY0b333397-0955-4e1b-9e63-37c8e4bdcde8

lidocaine 96 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1577070058OTC MONOGRAPH NOT FINALPound International Corp2013-05-09LIDOCAINETOPICALSPRAY, METERED3e9f369c-3361-467a-907a-52295baeb3ea

lidocaine hydrochloride 20 mg/ml topical spray

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1004980201OTC MONOGRAPH NOT FINALNorth Safety Products2013-03-15LIDOCAINE HYDROCHLORIDETOPICALSPRAY1297c11d-9c64-4bac-a576-2daad84df94f
2009240930OTC MONOGRAPH NOT FINALAcme United Corp2014-10-06LIDOCAINE HYDROCHLORIDETOPICALSPRAYce9f2aff-6b2a-4193-8046-dac0af0bb5f1
3476820225OTC MONOGRAPH NOT FINALUnifirst First Aid Corporation2013-04-12LIDOCAINE HYDROCHLORIDETOPICALSPRAY9fa5b348-29c2-4cd0-a945-0486bd27f5e0
4476820308OTC MONOGRAPH NOT FINALUnifirst First Aid Corporation2015-06-10LIDOCAINE HYDROCHLORIDETOPICALSPRAY4c2e2b91-d2f6-4e41-9a4c-ecabca9830e8
5598980201OTC MONOGRAPH NOT FINALWater-Jel Technologies2010-05-17LIDOCAINE HYDROCHLORIDETOPICALSPRAYc53ab9dd-351a-400b-b873-4f396e0af54d
6629855082OTC MONOGRAPH NOT FINALFirst Aid Only, Inc2014-08-13LIDOCAINE HYDROCHLORIDETOPICALSPRAYeaf73161-8597-4575-8b0f-be3e3389e5cc
7631810018OTC MONOGRAPH NOT FINALSesvalia Usa Llc2014-04-04LIDOCAINETOPICALSPRAYe4e00a64-1589-4a26-aa49-8b6facaeb64e
8669770117OTC MONOGRAPH NOT FINALMpm Medical, Inc.2009-06-01LIDOCAINE HYDROCHLORIDETOPICALGEL0eee554f-dfe0-433a-9665-8bdb95229888
9684215100OTC MONOGRAPH NOT FINALCintas First Aid & Safety2013-04-18, 2013-05-01LIDOCAINE HYDROCHLORIDETOPICALSPRAY96f17095-31f3-4b8a-ab22-0caaefaa7476, f612b9ad-c654-49ea-8619-3a1322ce70a7

lidocaine hydrochloride 25 mg/ml topical spray

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1598980510UnburnOTC MONOGRAPH NOT FINALWater-Jel Technologies2014-02-01LIDOCAINE HYDROCHLORIDETOPICALSPRAY40164231-1556-4714-9e27-9d41e3c71447

lidocaine hydrochloride 40 mg/ml topical spray

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1499470001OTC MONOGRAPH NOT FINALHush Anesthetic2012-12-01LIDOCAINETOPICALSPRAYc6e86a0f-6f9b-45b7-86ce-0bb1c198061a
2532000001Derma NumbOTC MONOGRAPH FINALAtlas Tat Inc.2012-07-15LIDOCAINE, LIDOCAINE HYDROCHLORIDETOPICALSPRAY64d07724-9e74-4320-9471-f9cdc80de7a4, 84c65be3-bee5-4da1-aba5-38779a6d9cdc
3532000010OTC MONOGRAPH NOT FINALAtlas Tat Inc.2015-10-01LIDOCAINE HYDROCHLORIDETOPICALSPRAYf65f9c69-4097-44e9-8c45-e2a2065c84ca
4573670001OTC MONOGRAPH FINAL220 Laboratories Inc1997-10-27LIDOCAINETOPICALAEROSOLdd564f66-a30d-4d19-96fe-200945ef90ca

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250714ANDARemedyrepack Inc.2013-09-25LIDOCAINE HYDROCHLORIDETOPICALSOLUTION006031394ANDA040710c6db3ce1-cf70-4f4a-9735-988eb4dad941, f5a6e7a4-8735-4acf-99e1-512ca288aabb

lidocaine hydrochloride 5 mg/ml topical spray

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1115230404SolarcaineOTC MONOGRAPH NOT FINALMsd Consumer Care, Inc.2012-04-06LIDOCAINETOPICALSPRAYdf8a384d-2263-43e8-94bd-1c7dbea9bc03
2461220113OTC MONOGRAPH NOT FINALAmerisource Bergen2011-10-28LIDOCAINECUTANEOUSSPRAY10980c50-c45d-4d81-b757-ab4e187c384e

lidocaine hydrochloride 50 mg/ml topical spray

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1532000005Derma NumbOTC MONOGRAPH NOT FINALAtlas Tat Inc.2014-08-06LIDOCAINETOPICALSPRAY839a8350-ded1-4504-a3d4-dfc2264bfc27

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA040710LIDOCAINE HYDROCHLORIDEVINTAGE PHARMACEUTICALS LLC2007-02-27ANDA040710_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
2ANDA080409LTA II KITHOSPIRA INCANDA080409_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
3ANDA085995PEDIATRIC LTA KITTrueHOSPIRA WORLDWIDE, INCANDA085995_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
4ANDA086364LARYNG-O-JET KITINTERNATIONAL MEDICATION SYSTEMANDA086364_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
5ANDA087881LIDOCAINE HYDROCHLORIDEWOCKHARDT EU OPERATIONS (SWISS) AG1982-11-18ANDA087881_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
6ANDA087931LARYNGOTRACHEAL ANESTHESIA KITTrueKENDALL CO1983-06-10ANDA087931_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
7ANDA088542LTA II KITTrueHOSPIRA INC1984-07-31ANDA088542_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
8ANDA088572PEDIATRIC LTA KITTrueABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIV1984-07-31ANDA088572_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
9ANDA088803LIDOCAINE HYDROCHLORIDEROXANE LABORATORIES INC1985-04-03ANDA088803_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
10ANDA089688LIDOCAINE HYDROCHLORIDETruePACO RESEARCH CORP1989-06-30ANDA089688_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
11ANDA204494LIDOCAINE HYDROCHLORIDEIGI LABORATORIES INC2014-03-12ANDA204494_001Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
12NDA010417XYLOCAINE 4% PRESERVATIVE FREEFRESENIUS KABI USA LLCNDA010417_001, NDA010417_002Lidocaine Prefilled Applicator
Lidocaine Injectable Solution
Epinephrine / Lidocaine Injectable Solution
Lidocaine Mucous Membrane Topical Solution
Lidocaine Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA040710_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseAT2007-02-27LIDOCAINE HYDROCHLORIDE
2ANDA080409_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseATLTA II KIT
3ANDA085995_001discontinuedLIDOCAINE HYDROCHLORIDE (2%)TOPICALSOLUTIONFalsePEDIATRIC LTA KIT
4ANDA086364_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseATLARYNG-O-JET KIT
5ANDA087881_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseAT1982-11-18LIDOCAINE HYDROCHLORIDE
6ANDA087931_001discontinuedLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalse1983-06-10LARYNGOTRACHEAL ANESTHESIA KIT
7ANDA088542_001discontinuedLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalse1984-07-31LTA II KIT
8ANDA088572_001discontinuedLIDOCAINE HYDROCHLORIDE (2%)TOPICALSOLUTIONFalse1984-07-31PEDIATRIC LTA KIT
9ANDA088803_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseAT1985-04-03LIDOCAINE HYDROCHLORIDE
10ANDA089688_001discontinuedLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalse1989-06-30LIDOCAINE HYDROCHLORIDE
11ANDA204494_001RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONFalseAT2014-03-12LIDOCAINE HYDROCHLORIDE
12NDA010417_001RXLIDOCAINE HYDROCHLORIDE (4%)INJECTIONTrueAPXYLOCAINE 4% PRESERVATIVE FREE
13NDA010417_002RXLIDOCAINE HYDROCHLORIDE (4%)TOPICALSOLUTIONTrueATXYLOCAINE 4% PRESERVATIVE FREE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
10b333397-0955-4e1b-9e63-37c8e4bdcde8 (view SPL)Aloe Burn ReliefotcHuman OTCChain Drug Consortium, Llc2015-10-202680160614
20eee554f-dfe0-433a-9665-8bdb95229888 (view SPL)Regenecare HAotcHuman OTCMpm Medical, Inc.manufacture2013-03-251669770117
310980c50-c45d-4d81-b757-ab4e187c384e (view SPL)Good Neighbor Pharmacy Burn ReliefotcHuman OTCAmerisource Bergenlabel, manufacture2015-07-171461220113
41297c11d-9c64-4bac-a576-2daad84df94f (view SPL)North Burn Relief SprayotcHuman OTCNorth Safety Productsmanufacture2013-03-151004980201
5169f94d4-2b0f-0044-e054-00144ff88e88 (view SPL)otcHuman OTCRidge Propertiesmanufacture2015-11-203698040001
623a0ec98-f528-4b1a-bf1c-006f7fd100b7 (view SPL)Res-Q Analgesic Topical Pain Relief SprayotcHuman OTCConair Corporationmanufacture2015-01-294128292001
72ad63160-4f6f-4970-80b6-f6d19c5660a5 (view SPL)Dynamo Delay Drug FactsotcHuman OTCMomentum Management2015-05-131696640001
83e9f369c-3361-467a-907a-52295baeb3ea (view SPL)Premjact Male Genital Desensitizer SprayotcHuman OTCPound International Corpmanufacture2015-01-125577070058
940164231-1556-4714-9e27-9d41e3c71447 (view SPL)Unburn SprayotcHuman OTCWater-Jel Technologiesmanufacture2014-01-241598980510
1041a35001-aa75-4157-b81c-a34b94afc50d (view SPL)LifeStyles EPIC Male Genital DesensitizerotcHuman OTCAnsell Healthcare Incmanufacture2012-04-182101880001
1142e75fb2-9ff8-4716-8baf-d013c181d972 (view SPL)otcHuman OTCCvslabel, manufacture2015-02-091597790230
124c2e2b91-d2f6-4e41-9a4c-ecabca9830e8 (view SPL)otcHuman OTCUnifirst First Aid CorporationMANUFACTURE2015-06-101476820308
1364d07724-9e74-4320-9471-f9cdc80de7a4 (view SPL)Derma Numb Tattoo Anesthetic SprayotcHuman OTCAtlas Tat Inc.2013-05-132532000001
14839a8350-ded1-4504-a3d4-dfc2264bfc27 (view SPL)Derma Numb Tattoo Anesthetic SprayotcHuman OTCAtlas Tat Inc.2014-08-061532000005
1584c65be3-bee5-4da1-aba5-38779a6d9cdc (view SPL)Derma Numb Tattoo Anesthetic SprayprescriptionHuman PrescriptionAtlas Tat Inc.2012-10-031532000001
1688bf3651-4d8f-4132-92a5-674f6c7bbbd6 (view SPL)Burn Relief SprayotcHuman OTCPremier Brands Of America Inc.relabel, repack2013-10-291561040006
1796f17095-31f3-4b8a-ab22-0caaefaa7476 (view SPL)otcHuman OTCCintas First Aid & SafetyMANUFACTURE2015-09-032684215100
189fa5b348-29c2-4cd0-a945-0486bd27f5e0 (view SPL)otcHuman OTCUnifirst First Aid CorporationMANUFACTURE2015-06-042476820225
19aa39c75e-5efb-435b-95ab-a41cfc36e4f2 (view SPL)Fruit of the Earth Cool Blue Aloe Mist Continuous SprayotcHuman OTCFruit Of The Earth, Inc.manufacture2014-09-121622170201
20b137868b-1086-44a2-a594-6e7cb7160a03 (view SPL)Drug FactsotcHuman OTCInnocoll Pharmaceuticals2011-12-292517150001
21c53ab9dd-351a-400b-b873-4f396e0af54d (view SPL)Burn SprayotcHuman OTCWater-Jel Technologiesmanufacture2010-05-224598980201
22c6db3ce1-cf70-4f4a-9735-988eb4dad941 (view SPL)LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION USP, 4%prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-252521250714
23c6e86a0f-6f9b-45b7-86ce-0bb1c198061a (view SPL)Derma Numb Tattoo Anesthetic SprayotcHuman OTCHush Anesthetic2012-09-123499470001
24cc8d34f0-91e0-44b7-9fe4-4c31f7d98a8d (view SPL)Burn Relief SprayotcHuman OTCWalgreenslabel, manufacture2015-01-201003633107
25ce9f2aff-6b2a-4193-8046-dac0af0bb5f1 (view SPL)otcHuman OTCAcme United CorpMANUFACTURE2014-10-062009240930
26dd564f66-a30d-4d19-96fe-200945ef90ca (view SPL)NUMBING SPRAY CONTAINERotcHuman OTC220 Laboratories Incmanufacture2010-05-105573670001
27df8a384d-2263-43e8-94bd-1c7dbea9bc03 (view SPL)Solarcaine cool aloe sprayotcHuman OTCMsd Consumer Care, Inc.MANUFACTURE2013-08-302115230404
28e4e00a64-1589-4a26-aa49-8b6facaeb64e (view SPL)Sesderma LIDOCARE MISTotcHuman OTCSesvalia Usa LlcMANUFACTURE2014-04-041631810018
29eaf73161-8597-4575-8b0f-be3e3389e5cc (view SPL)otcHuman OTCFirst Aid Only, IncMANUFACTURE2014-08-131629855082
30f5a6e7a4-8735-4acf-99e1-512ca288aabb (view SPL)LIDOCAINE HYDROCHLORIDE TOPICAL SOLUTION USP, 4%prescriptionHuman PrescriptionRemedyrepack Inc.2013-09-252521250714
31f612b9ad-c654-49ea-8619-3a1322ce70a7 (view SPL)otcHuman OTCCintas First Aid & SafetyMANUFACTURE2013-04-181684215100
32f65f9c69-4097-44e9-8c45-e2a2065c84ca (view SPL)Derma Numb Tattoo Anesthetic SprayotcHuman OTCAtlas Tat Inc.2015-10-151532000010

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII