Hydrocortisone Topical Solution

Brand(s)
Cortizone-10, Locoid, Scalpicin Itch Relief, Selsun Blue Scalp Itch, Texacort
Category(s)
otc, prescription
SPL Type(s)
Human OTC, Human Prescription
Master SPL
Chattem, Inc. (2015-05-22)
Oldest Current Product
1992-12-15
License(s)
NDA, ANDA, OTC MONOGRAPH FINAL, OTC MONOGRAPH NOT FINAL
RxNORM
TOPICAL SOLUTION\HYDROCORTISONE
FDAOB
TOPICAL\SOLUTION\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE BUTYRATE
SPL Active
TOPICAL\LIQUID\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE BUTYRATE
SPL Moiety
TOPICAL\LIQUID\HYDROCORTISONE
TOPICAL\SOLUTION\HYDROCORTISONE

product(s) by strength(s)

hydrocortisone 10 mg/ml topical solution

product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1115095400Scalpicin Itch ReliefOTC MONOGRAPH FINALCombe Incorporated1992-12-15HYDROCORTISONETOPICALLIQUID45d51ae3-404a-44c6-8cbd-3eb30fbad1e7
2411670032Cortizone-10OTC MONOGRAPH NOT FINALChattem, Inc.2008-10-01HYDROCORTISONETOPICALLIQUIDbeb73818-cd88-44ff-8ecd-b02b910b53b7
3411676040Selsun Blue Scalp ItchOTC MONOGRAPH NOT FINALChattem, Inc.2013-10-01HYDROCORTISONETOPICALLIQUIDda86eff4-bf3e-4836-861e-ffe01dd5ff62
4597790318OTC MONOGRAPH FINALCvs2010-07-16HYDROCORTISONETOPICALLIQUID0d72f26d-304c-4541-844a-76865f7c7fc5
5617340415OTC MONOGRAPH NOT FINALDelon Laboratories (1990) Ltd2014-09-08HYDROCORTISONETOPICALSOLUTION8aa175be-cc8b-4ff6-9746-c95efbe0d032
6638240850Scalpicin Itch ReliefOTC MONOGRAPH NOT FINALReckitt Benckiser Llc2012-01-16HYDROCORTISONETOPICALLIQUID94a3625d-8022-4bd4-a8a1-6ae380be6677
7638240851Scalpicin Itch ReliefOTC MONOGRAPH NOT FINALReckitt Benckiser Llc2012-10-15HYDROCORTISONETOPICALLIQUID7b1a29fa-b266-43e6-a87b-aa3c96ab4041

hydrocortisone 25 mg/ml topical solution

generic product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001780455TexacortANDAMission Pharmacal Company2011-12-15HYDROCORTISONETOPICALSOLUTIONANDA08127125279d46-6bad-471f-8bd6-736d53cfd942

hydrocortisone 5 mg/ml topical solution

product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1252800004OTC MONOGRAPH NOT FINALLoesch Laboratory Consultants, Inc.2014-06-26HYDROCORTISONETOPICALLIQUID595bf774-2d0f-4316-a328-071c87aae2fe

hydrocortisone butyrate 1 mg/ml topical solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1434780273NDARouses Point Pharm2010-02-24HYDROCORTISONE BUTYRATETOPICALSOLUTIONNDA0191167db9b9c4-9591-4ac4-abff-9c3c203cecb1

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1516724061ANDATaro Pharmaceuticals U.S.A., Inc.2004-01-14HYDROCORTISONE BUTYRATETOPICALSOLUTIONANDA07636451176835-598d-4da7-8a00-6bd36f52aa82

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA076364HYDROCORTISONE BUTYRATETARO PHARMACEUTICAL INDUSTRIES LTD2004-01-14ANDA076364_001
2ANDA080425TEXACORTTrueMISSION PHARMACAL COANDA080425_001
3ANDA081271TEXACORTMISSION PHARMACAL CO1992-04-17ANDA081271_001
4ANDA088214PENECORTTrueALLERGAN HERBERT SKIN CARE DIV ALLERGAN INC1984-06-06ANDA088214_001
5NDA019116LOCOIDPRECISION DERMATOLOGY INC1987-02-25NDA019116_001
6NDA019819LOCOIDTrueYAMANOUCHI EUROPE BV1988-09-15NDA019819_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA076364_001RXHYDROCORTISONE BUTYRATE (0.1%)TOPICALSOLUTIONFalseAT2004-01-14HYDROCORTISONE BUTYRATE
2ANDA080425_001discontinuedHYDROCORTISONE (1%)TOPICALSOLUTIONFalseTEXACORT
3ANDA081271_001RXHYDROCORTISONE (2.5%)TOPICALSOLUTIONTrue1992-04-17TEXACORT
4ANDA088214_001discontinuedHYDROCORTISONE (1%)TOPICALSOLUTIONFalse1984-06-06PENECORT
5NDA019116_001RXHYDROCORTISONE BUTYRATE (0.1%)TOPICALSOLUTIONTrueAT1987-02-25LOCOID
6NDA019819_001discontinuedHYDROCORTISONE BUTYRATE (0.1%)TOPICALSOLUTIONFalse1988-09-15LOCOID

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10d72f26d-304c-4541-844a-76865f7c7fc5 (view SPL)drug factsotcHuman OTCCvsmanufacture2010-07-161597790318
225279d46-6bad-471f-8bd6-736d53cfd942 (view SPL)Texacort Topical Solution 2.5%prescriptionHuman PrescriptionMission Pharmacal CompanyMANUFACTURE2012-03-121001780455
345d51ae3-404a-44c6-8cbd-3eb30fbad1e7 (view SPL)Scalpicin Scalp Itch Medication Maximum StrengthotcHuman OTCCombe IncorporatedMANUFACTURE2009-12-312115095400
451176835-598d-4da7-8a00-6bd36f52aa82 (view SPL)Hydrocortisone Butyrate Ointment, 0.1% Hydrocortisone Butyrate Cream USP, 0.1% Hydrocortisone Butyrate Topical Solution, 0.1%prescriptionHuman PrescriptionTaro Pharmaceuticals U.S.A., Inc.MANUFACTURE2015-01-223516724061, 516724074, 516724083Hydrocortisone Topical Ointment
Hydrocortisone Topical Cream
5595bf774-2d0f-4316-a328-071c87aae2fe (view SPL)Loesch Anti-Itch TherapyotcHuman OTCLoesch Laboratory Consultants, Inc.manufacture2014-06-261252800004
67b1a29fa-b266-43e6-a87b-aa3c96ab4041 (view SPL)Scalpicin Anti-Itch Maximum StrengthotcHuman OTCReckitt Benckiser Llc2012-11-161638240851
77db9b9c4-9591-4ac4-abff-9c3c203cecb1 (view SPL)Hydrocortisone Butyrate Solution, 0.1% For Dermatological Use OnlyprescriptionHuman PrescriptionRouses Point PharmANALYSIS, API MANUFACTURE, MANUFACTURE2014-07-094434780273
88aa175be-cc8b-4ff6-9746-c95efbe0d032 (view SPL)Drug FactsotcHuman OTCDelon Laboratories (1990) Ltdlabel, manufacture, pack2014-09-081617340415
994a3625d-8022-4bd4-a8a1-6ae380be6677 (view SPL)Scalpicin Maximum StrengthotcHuman OTCReckitt Benckiser Llc2012-06-261638240850
10beb73818-cd88-44ff-8ecd-b02b910b53b7 (view SPL)Cortizone 10 Easy ReliefotcHuman OTCChattem, Inc.ANALYSIS, MANUFACTURE, RECOVERY, RELABEL, REPACK2009-11-062411670032
11c3360b20-8409-4a8a-b77a-4f6fb1ac6b25 (view SPL)Locoid (hydrocortisone butyrate) Solution, 0.1%prescriptionHuman PrescriptionOnset Dermatologics, LlcMANUFACTURE2014-11-053167810391
12da86eff4-bf3e-4836-861e-ffe01dd5ff62 (view SPL)Selsun Blue Scalp Itch TreatmentotcHuman OTCChattem, Inc.2015-05-222411676040

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