Naphazoline / Pheniramine Ophthalmic Solution

Brand(s)
Naphcon A, Opcon-A, Visine-A
Category(s)
otc
SPL Type(s)
Human OTC
Master SPL
Johnson & Johnson Consumer Inc. (2015-10-09)
Oldest Current Product
1994-06-08
License(s)
NDA, ANDA
RxNORM
OPHTHALMIC SOLUTION\NAPHAZOLINE:PHENIRAMINE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\NAPHAZOLINE HYDROCHLORIDE: PHENIRAMINE MALEATE
SPL Active
OPHTHALMIC\SOLUTION/DROPS\NAPHAZOLINE HYDROCHLORIDE: PHENIRAMINE MALEATE
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\NAPHAZOLINE: PHENIRAMINE

product(s) by strength(s)

naphazoline hydrochloride 0.25 mg/ml / pheniramine maleate 3 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1420020200Visine-ANDAJohnson & Johnson Consumer Inc.2010-12-15NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA02048582500e4c-bc01-4ce0-80d8-6e9f0be99163

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1003639650ANDAWalgreens2013-04-23NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA2027952f0592a4-af44-464b-8d08-7727c2fc1ca8
2174780065ANDAAkorn2013-01-24NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA20279578c5250c-b27c-4b1d-a4b8-571973ac3ae4
3597790365ANDACvs2013-01-25NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA202795a87837f8-1549-4b53-9cd9-e386f67e3195
4597790366ANDACvs2013-01-25NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA2027955aeeb85c-9f9e-4a37-b6fb-769fa24f7767
5680160450ANDAChain Drug Consortium, Llc2014-01-10NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA20279557e4f554-a0c5-46e1-8b19-dd6559b25c9f

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250558Naphcon ANDARemedyrepack Inc.2015-06-22NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPS000650085NDA020226b83701b9-9331-484f-8e84-6e241e621ff3

naphazoline hydrochloride 0.27 mg/ml / pheniramine maleate 3.15 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1118220552NDARite Aid2015-07-01NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA0200656043040e-3206-40dd-aa87-940b1a84a496
2118223865NDARite Aid2010-08-31NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA02006510ec7dfa-0fc2-424c-b65b-69ba566340a6
3242080430Opcon-ANDABausch & Lomb Incorporated1994-06-08NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA02006590a05c13-5b87-415b-9892-10d2edbc1943
4490350430NDAWalmart2010-08-31NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA020065873a072f-159b-44b8-aad8-33963d961afb
5597790042NDACvs2010-08-31NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSNDA02006535a6bb06-efa2-4482-938b-66b6d41ab823

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1593900177ANDAAltaire Pharmaceuticals Inc.2010-10-06NAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATEOPHTHALMICSOLUTION/DROPSANDA0782085649c6e2-966f-44d9-b57e-5bb988eb373d

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078208NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEALTAIRE PHARMACEUTICALS INC2010-09-27ANDA078208_001
2ANDA202795NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEAKORN INC2013-01-24ANDA202795_001
3NDA020065OPCON-ABAUSCH AND LOMB INC1994-06-08NDA020065_001
4NDA020226NAPHCON-AALCON LABORATORIES INC1994-06-08NDA020226_001
5NDA020485VISINE-AJOHNSON AND JOHNSON CONSUMER INC1996-01-31NDA020485_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1ANDA078208_001OTCPHENIRAMINE MALEATE (0.315%), NAPHAZOLINE HYDROCHLORIDE (0.02675%)OPHTHALMICSOLUTION/DROPSFalse2010-09-27NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
2ANDA202795_001OTCNAPHAZOLINE HYDROCHLORIDE (0.025%), PHENIRAMINE MALEATE (0.3%)OPHTHALMICSOLUTION/DROPSFalse2013-01-24NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
3NDA020065_001OTCNAPHAZOLINE HYDROCHLORIDE (0.02675%), PHENIRAMINE MALEATE (0.315%)OPHTHALMICSOLUTION/DROPSTrue1994-06-08OPCON-A
4NDA020226_001OTCNAPHAZOLINE HYDROCHLORIDE (0.025%), PHENIRAMINE MALEATE (0.3%)OPHTHALMICSOLUTION/DROPSTrue1994-06-08NAPHCON-A
5NDA020485_001OTCPHENIRAMINE MALEATE (0.3%), NAPHAZOLINE HYDROCHLORIDE (0.025%)OPHTHALMICSOLUTION/DROPSTrue1996-01-31VISINE-A

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
110ec7dfa-0fc2-424c-b65b-69ba566340a6 (view SPL)Drug FactsotcHuman OTCRite AidAPI MANUFACTURE, MANUFACTURE2015-01-283118223865
22f0592a4-af44-464b-8d08-7727c2fc1ca8 (view SPL)otcHuman OTCWalgreensANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-04-232003639650
335a6bb06-efa2-4482-938b-66b6d41ab823 (view SPL)Drug FactsotcHuman OTCCvsAPI MANUFACTURE, MANUFACTURE2015-10-233597790042
44d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 (view SPL)Drug FactsotcHuman OTCAlcon Laboratories, Inc.MANUFACTURE2009-11-017000650085
55649c6e2-966f-44d9-b57e-5bb988eb373d (view SPL)Naphazoline HCI 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, USPotcHuman OTCAltaire Pharmaceuticals Inc.manufacture2010-10-061593900177
657e4f554-a0c5-46e1-8b19-dd6559b25c9f (view SPL)otcHuman OTCChain Drug Consortium, LlcANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2015-10-233680160450
75aeeb85c-9f9e-4a37-b6fb-769fa24f7767 (view SPL)otcHuman OTCCvsANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-05-293597790366
86043040e-3206-40dd-aa87-940b1a84a496 (view SPL)Drug FactsotcHuman OTCRite AidAPI MANUFACTURE, MANUFACTURE2015-07-171118220552
978c5250c-b27c-4b1d-a4b8-571973ac3ae4 (view SPL)otcHuman OTCAkornANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-01-291174780065
10806ad1b6-0de7-4e9a-be86-475c0ef2c340 (view SPL)Drug FactsotcHuman OTCTarget CorpAPI MANUFACTURE, MANUFACTURE2015-10-164116730430
1182500e4c-bc01-4ce0-80d8-6e9f0be99163 (view SPL)Visine-A Multi-Action Eye Allergy ReliefotcHuman OTCJohnson & Johnson Consumer Inc.2015-10-095420020200
1282a99ff3-4f57-42e6-82f4-769d6418be7c (view SPL)Drug FactsotcHuman OTCDolgencorp, LlcAPI MANUFACTURE, MANUFACTURE2015-07-171559100552
13873a072f-159b-44b8-aad8-33963d961afb (view SPL)Drug FactsotcHuman OTCWalmartAPI MANUFACTURE, MANUFACTURE2015-10-163490350430
1490a05c13-5b87-415b-9892-10d2edbc1943 (view SPL)Drug FactsotcHuman OTCBausch & Lomb IncorporatedAPI MANUFACTURE, MANUFACTURE2015-01-283242080430
15a87837f8-1549-4b53-9cd9-e386f67e3195 (view SPL)otcHuman OTCCvsANALYSIS, LABEL, MANUFACTURE, PACK, STERILIZE2013-11-195597790365
16b83701b9-9331-484f-8e84-6e241e621ff3 (view SPL)Drug FactsotcHuman OTCRemedyrepack Inc.2015-06-221521250558
17ddd892af-56d0-4755-af87-807ea8f8e9ca (view SPL)Drug FactsotcHuman OTCWalgreensAPI MANUFACTURE, MANUFACTURE2015-01-283003630430
18fd1e7e65-2c34-42ba-96cf-f8a17785fcf7 (view SPL)Drug FactsotcHuman OTCCvsAPI MANUFACTURE, MANUFACTURE2015-07-171597790552

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