Home NDC 0065-0085 Naphcon A
Product NDC 0065-0085
11-digit product format 000650085
Labeler code 0065
Product ID 0065-0085_96b9fdb6-f4fe-4350-93a5-d7cfacc83af0
Type HUMAN OTC DRUG
Nonproprietary name naphazoline hydrochloride and pheniramine maleate
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA020226
Marketing category NDA
Marketing start 1994-06-08
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 N020226-001 NAPHCON-A NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08
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 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 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020226-001 NAPHCON-A 0.025%;0.3% SOLUTION/DROPS / OPHTHALMIC RLD, RS 1994-06-08 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Naphcon A
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1043658 Internal RxNorm lookup 1046266 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Naphazoline Hydrochloride ACTIVE INGREDIENT MZ1131787D NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Pheniramine Maleate ACTIVE INGREDIENT NYW905655B NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Naphazoline ACTIVE MOIETY H231GF11BV NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Pheniramine ACTIVE MOIETY 134FM9ZZ6M NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Sodium Borate INACTIVE INGREDIENT 91MBZ8H3QO NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7 Water INACTIVE INGREDIENT 059QF0KO0R NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0065-0085 NAPHCON A (NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALCON LABORATORIES, INC.] 16 Current NDC, Legacy NDC, 8 package rows 20240331_4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58.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 · 2 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 0065-0085-15 00065008515 1 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE 1 bottle 1995-01-03 0000-00-00 No No Current 0065-0085-38 00065008538 1 in 1 CARTON Historical 0065-0085-42 00065008542 2 BOTTLE in 1 CARTON (0065-0085-42) > 5 mL in 1 BOTTLE 2 bottle 1994-06-08 2023-11-01 No No Current 0065-0085-52 00065008552 1 BOTTLE in 1 CARTON (0065-0085-52) > 5 mL in 1 BOTTLE 1 bottle 1994-06-08 0000-00-00 No No Current