Home NDC 69968-0367 Visine Allergy Eye Relief Multi-Action
Product NDC 69968-0367
11-digit product format 699680367
Labeler code 69968
Product ID 69968-0367_21eaa17e-eb96-aa1d-e063-6394a90a9870
Type HUMAN OTC DRUG
Nonproprietary name Naphazoline Hydrochloride and Pheniramine Maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Kenvue Brands LLC
Application NDA020485
Marketing category NDA
Marketing start 2019-05-06
Substance NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
Active strength .25; 3 mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020485-001 VISINE NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31
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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020485-001 VISINE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1996-01-31 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Visine Allergy Eye Relief Multi-Action
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NAPHAZOLINE HYDROCHLORIDE .25 mg/mL PHENIRAMINE MALEATE 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination MZ1131787D Internal UNII lookup NYW905655B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043658 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69968-0367-1 Visine Allergy Eye Relief Multi-Action 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 8 69968-0367-1 Visine Allergy Eye Relief Multi-Action 1 in 1 CARTON SOLUTION/ DROPS 1 8 69968-0367-2 Visine Allergy Eye Relief Multi-Action 15 mL in 1 BOTTLE SOLUTION/ DROPS 15 8 69968-0367-2 Visine Allergy Eye Relief Multi-Action 2 in 1 CARTON SOLUTION/ DROPS 2 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69968-0367 VISINE ALLERGY EYE RELIEF MULTI-ACTION (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [KENVUE BRANDS LLC] 8 Current NDC, Legacy NDC, 4 package rows 20241115_125fbc97-5bc8-436e-9ee9-e5a44384e260.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69968-0367-1 69968036701 1 BOTTLE in 1 CARTON (69968-0367-1) / 15 mL in 1 BOTTLE 1 bottle 2019-05-06 0000-00-00 No No Current 69968-0367-2 69968036702 2 BOTTLE in 1 CARTON (69968-0367-2) / 15 mL in 1 BOTTLE 2 bottle 2019-06-03 0000-00-00 No No Current