Storage and handling
Store at room temperature 20 degrees - 25 degrees C ( 68 degrees - 77 degrees F). Protect from light.
Naphazoline HCI 0.027% & Pheniramine Maleate 0.315% Ophthalmic Solution, USP
- Manufacturer
- Altaire Pharmaceuticals Inc.
- Effective date
- 2020-12-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-05-31 23:35:58
Label at a glance#
ProductNaphazoline HCI And Pheniramine Maleate
Active ingredientNAPHAZOLINE HYDROCHLORIDE, PHENIRAMINE MALEATE
Label structure18 sections
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients
Naphazoline Hydrochloride (0.027%)
Pheniramine Maleate (0.315%)
OTC - PURPOSE SECTION
Purpose
Redness Reliever
Antihistamine
INDICATIONS & USAGE SECTION
Uses: temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.
WARNINGS SECTION
Warnings: if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a physician. Do not use in children under 6 years of age unless directed by a physician. If this solution changes color or becomes cloudy, do not use. Overuse of this product may produce increased redness of the eye.
If you are sensitive to any ingredient in this product, do not use. To avoid contamination, do not touch tip of container to any surface. Replace cap after using.
OTC - DO NOT USE SECTION
Do not use if imprinted seal on cap is torn, broken or missing, or if imprinted seals on top ad bottom flaps are not intact and completely legible.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
- heart disease
- high blood pressure
- trouble urinating due to enlarged prostrate gland
- narrow angle glaucoma
OTC - WHEN USING SECTION
Remove contact lenses before using.
OTC - STOP USE SECTION
Stop use and ask a doctor if you experience: eye pain, changes in vision, redness or irritation of the eye that worsens or persists for more than 72 hours. Overuse of this product may produce increased redness of the eye. Pupils may become enlarged temporarily. You may experience a brief tingling sensation after putting drops in eyes.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.
DOSAGE & ADMINISTRATION SECTION
Directions:
Adults and children 6 years of age and older: instill 1 or 2 drops in affected eye(s) up to 4 times daily.
Children under 6 years: ask a doctor.
STORAGE AND HANDLING SECTION
Store at room temperature 20 degrees - 25 degrees C ( 68 degrees - 77 degrees F).
Protect from light.
SPL UNCLASSIFIED SECTION
Use before expiration date marked on the carton or bottle.
Available in 15mL NDC 59390-177-13 and 30 mL NDC 59390-177-18
INACTIVE INGREDIENT SECTION
Inactive ingredients
benzalkonium chloride 0.01%, boric acid, edetate disodium 0.1%, hypromellose, purified water, sodium borate, and sodium chloride.
OTC - QUESTIONS SECTION
Questions or comments
Call (631) 722-5988 9am - 5pm EST Monday - Friday
SPL UNCLASSIFIED SECTION
Manufactured by:
Altaire Pharmaceuticals, Inc.
Aquebogue, N.Y. 11931
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ALTAIRE Pharmaceuticals, Inc.
Aquebogue, N.Y. 11931
Naphazoline HCI 0.027%
and
Pheniramine Maleate 0.315%
Ophthalmic Solution, USP
Eye Allergy Relief
With Antihistamine To Relieve Itching
Itching and Redness Reliever
Eye Drops
0.5 Fl. OZ. (15mL)
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1043704 | naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution | PSN | 4 |
| 1043704 | naphazoline hydrochloride 0.27 MG/ML / pheniramine maleate 3.15 MG/ML Ophthalmic Solution | SCD | 4 |
| 1043704 | naphazoline HCl 0.02675 % / pheniramine maleate 0.315 % Ophthalmic Solution | SY | 4 |
| 1043704 | naphazoline HCl 0.027 % / pheniramine maleate 0.315 % Ophthalmic Solution | SY | 4 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| e18001c8-33ae-5f66-9cdc-a39724bd4573 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 59390-177-13 | Naphazoline HCI And Pheniramine Maleate | 15 mL in 1 BOTTLE, DROPPER | SOLUTION/ DROPS | 15 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 59390-177 | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20201229_5649c6e2-966f-44d9-b57e-5bb988eb373d.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| NAPHAZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | MZ1131787D | 1 | |
| PHENIRAMINE MALEATE | ACTIVE INGREDIENT | NYW905655B | 1 | |
| NAPHAZOLINE | ACTIVE MOIETY | H231GF11BV | 1 | |
| PHENIRAMINE | ACTIVE MOIETY | 134FM9ZZ6M | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | 1 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Naphazoline HCI And Pheniramine Maleate
- NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
- BENZALKONIUM CHLORIDE
- BORIC ACID
- EDETATE DISODIUM
- HYPROMELLOSE, UNSPECIFIED
- WATER
- SODIUM BORATE
- SODIUM CHLORIDE
- NAPHAZOLINE HYDROCHLORIDE
- NAPHAZOLINE
- PHENIRAMINE MALEATE
- PHENIRAMINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59390-177 | 59390-177-13 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZALKONIUM CHLORIDE | F5UM2KM3W7 | IACT |
| BORIC ACID | R57ZHV85D4 | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| HYPROMELLOSE, UNSPECIFIED | 3NXW29V3WO | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BORATE | 91MBZ8H3QO | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | IACT |
| NAPHAZOLINE HYDROCHLORIDE | MZ1131787D | ACTIB |
| PHENIRAMINE MALEATE | NYW905655B | ACTIB |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | SOLUTION/ DROPS / OPHTHALMIC | 1.1 %w/v | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| BENZALKONIUM CHLORIDE | BENZALKONIUM CHLORIDE | F5UM2KM3W7 | SOLUTION/ DROPS / OPHTHALMIC | 1 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SODIUM CHLORIDE | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / OPHTHALMIC | 55 mg | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION / OPHTHALMIC | 0.5 %w/w | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| BORIC ACID | BORIC ACID | R57ZHV85D4 | SOLUTION/ DROPS / OPHTHALMIC | 48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION/ DROPS / OPHTHALMIC | 0.13 %w/v | ||
| HYPROMELLOSE | HYPROMELLOSE | 3NXW29V3WO | SUSPENSION/ DROPS / OPHTHALMIC | 3 mg | ||
| SODIUM BORATE | SODIUM BORATE | 91MBZ8H3QO | SOLUTION/ DROPS / OPHTHALMIC | 1.1 %w/v |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A078208-001 | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | 0.02675%;0.315% | SOLUTION/DROPS / OPHTHALMIC | 2010-09-27 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Naphazoline HCI And Pheniramine Maleate | NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE | Altaire Pharmaceuticals Inc. | 5649c6e2-966f-44d9-b57e-5bb988eb373d | 2020-12-28 | Warnings | 59390-177-13 59390-177 59390017713 b78fd969-ee4c-0ea0-e053-2a95a90a480d 5649c6e2-966f-44d9-b57e-5bb988eb373d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.