FDA.reportPublic FDA data

Application 020065

Type
NDA
Sponsor
BAUSCH AND LOMB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.02675%;0.315%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020065-001OPCON-ANAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020065-001OPCON-A0.02675%;0.315%SOLUTION/DROPS / OPHTHALMICRLD, RS1994-06-08a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Opcon-ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEBausch & Lomb Incorporated2d7cfae7-8af4-4fee-93e1-e5cfe455c5a52026-03-20WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEWalgreen Companyddd892af-56d0-4755-af87-807ea8f8e9ca2026-01-14WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (product): 0363-0430
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDETarget Corporation806ad1b6-0de7-4e9a-be86-475c0ef2c3402025-03-28WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (product): 11673-430
Opcon-ANAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEBausch & Lomb Incorporated90a05c13-5b87-415b-9892-10d2edbc19432023-12-14WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (product): 24208-430
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEWal-Mart Stores Inc873a072f-159b-44b8-aad8-33963d961afb2021-04-05WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (product): 49035-430
Eye Allergy ReliefPHENIRAMINE MALEATE AND NAPHAZOLINE HYDROCHLORIDEDOLGENCORP, LLC82a99ff3-4f57-42e6-82f4-769d6418be7c2020-01-27WarningsExact identifier
application applno (NDA): 020065
application number: NDA020065
ndc (product): 55910-552

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-0430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-9652Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
0363-9652Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWalgreen CompanyNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11673-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideTarget CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-0552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-3865Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
11822-3865Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideRite Aid CorporationNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
24208-430Opcon-ANaphazoline hydrochloride and Pheniramine maleateBausch & Lomb IncorporatedNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
49035-430Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideWal-Mart Stores IncNDACurrent
55910-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideDOLGENCORP, LLCNDACurrent
55910-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideDOLGENCORP, LLCNDACurrent
59779-042Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideCVS PharmacyNDACurrent
59779-552Eye Allergy ReliefPheniramine Maleate and Naphazoline HydrochlorideCVS PharmacyNDACurrent
69842-441EYE ALLERGY RELIEFNaphazoline hydrochloride and Pheniramine maleateCVS PHARMACYNDACurrent
70518-0475Opcon-ANaphazoline hydrochloride and Pheniramine maleateREMEDYREPACK INC.NDACurrent
70518-0475Opcon-ANaphazoline hydrochloride and Pheniramine maleateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72245SUPPL2022-10-05
72152SUPPL2022-09-26
12166SUPPL2007-08-02
1964SUPPL2007-08-02
1963SUPPL2005-04-28