FDA.reportPublic FDA data

Application 020485

Type
NDA
Sponsor
JOHNSON AND JOHNSON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VISINENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATESOLUTION/DROPS;OPHTHALMIC0.025%;0.3%YesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N020485-001VISINENAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020485-001VISINE0.025%;0.3%SOLUTION/DROPS / OPHTHALMICRLD, RS1996-01-31a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Visine Allergy Eye Relief Multi-ActionNAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEKenvue Brands LLC125fbc97-5bc8-436e-9ee9-e5a44384e2602024-11-13WarningsExact identifier
application applno (NDA): 020485
application number: NDA020485
ndc (product): 69968-0367

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42002-200Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0063Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0063Visine ANaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
69968-0367Visine Allergy Eye Relief Multi-ActionNaphazoline Hydrochloride and Pheniramine MaleateJohnson & Johnson Consumer Inc.NDACurrent
70518-0817Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent
70518-1729Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent
70518-1729Visine ANaphazoline Hydrochloride and Pheniramine MaleateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83903SUPPL 2025-10-23
83901SUPPL 2025-10-23
56099SUPPL2018-10-26
56056SUPPL2018-10-23
45179SUPPL2016-08-26
12628SUPPL2014-01-14
25031SUPPL2012-12-21
2593SUPPL2004-10-22
34699SUPPL2003-09-25
25030SUPPL2003-09-25
25029SUPPL2002-06-14
12627SUPPL2002-06-14