Naphcon A
- Product NDC
- 0065-0085
- Requested package NDC
- 0065-0085-42
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 0065-0085 | 0065-0085-42 | D | Discontinued by firm | 2026-09-14 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020226-001 | NAPHCON-A | 0.025%;0.3% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 1994-06-08 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020226-001 | NAPHCON-A | 0.025%;0.3% | SOLUTION/DROPS / OPHTHALMIC | RLD, RS | 1994-06-08 | caaa826d4ba7… | |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naphcon A
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| NAPHAZOLINE HYDROCHLORIDE | .25 mg/mL |
| PHENIRAMINE MALEATE | 3 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| MZ1131787D | Internal UNII lookup |
| NYW905655B | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0065-0085-15 | Naphcon A | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0065-0085-15 | Naphcon A | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | 16 | |
| 0065-0085-38 | Naphcon A | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 | |
| 0065-0085-38 | Naphcon A | 30 mL in 1 BOTTLE | SOLUTION/ DROPS | 30 | 16 | |
| 0065-0085-42 | Naphcon A | 2 in 1 CARTON | SOLUTION/ DROPS | 2 | 16 | |
| 0065-0085-42 | Naphcon A | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 16 | |
| 0065-0085-52 | Naphcon A | 5 mL in 1 BOTTLE | SOLUTION/ DROPS | 5 | 16 | |
| 0065-0085-52 | Naphcon A | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0065-0085-15 | ML - Milliliter | 0065-0085 | 089b2d21-fcf9-4e1a-a86b-bdd8e313cfdb | 1 | 2013-02-13 |
| 0065-0085-42 | ML - Milliliter | 0065-0085 | af92d8ef-1313-424b-a7b4-5dac3652e96f | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naphcon A | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | Alcon Laboratories, Inc. | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 2024-03-27 | Warnings | 020226 NDA020226 0065-0085-42 0065-0085 00065008542 |
| Naphcon A | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | A-S Medication Solutions | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 2023-10-25 | Warnings | 020226 NDA020226 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1043658 | naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic Solution | PSN | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1046266 | NAPHCON A 0.025 % / 0.3 % Ophthalmic Solution | PSN | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1046266 | naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A] | SBD | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1043658 | naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution | SCD | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1043658 | naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic Solution | SY | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1046266 | Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic Solution | SY | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1046266 | Naphcon A 0.025 % / 0.3 % Ophthalmic Solution | SY | 4d8412ff-0e59-4a6a-9f3e-4e6f6204bf58 | 16 |
| 1043658 | naphazoline HCl 0.025 % / pheniramine maleate 0.3 % Ophthalmic Solution | PSN | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1046266 | NAPHCON A 0.025 % / 0.3 % Ophthalmic Solution | PSN | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1046266 | naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution [Naphcon A] | SBD | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1043658 | naphazoline hydrochloride 0.25 MG/ML / pheniramine maleate 3 MG/ML Ophthalmic Solution | SCD | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1043658 | naphazoline hydrochloride 0.025 % / pheniramine maleate 0.3 % Ophthalmic Solution | SY | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1046266 | Naphcon A (naphazoline HCl 0.025 % / pheniramine maleate 0.3 % ) Ophthalmic Solution | SY | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
| 1046266 | Naphcon A 0.025 % / 0.3 % Ophthalmic Solution | SY | df40c426-ef66-4688-b5b5-c6fc5556e9a8 | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 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 |