Naphazoline HCI And Pheniramine Maleate
- Product NDC
- 59390-177
- 11-digit product format
- 593900177
- Labeler code
- 59390
- Product ID
- 59390-177_b78fd969-ee4c-0ea0-e053-2a95a90a480d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Altaire Pharmaceuticals Inc.
- Application
- ANDA078208
- Marketing category
- ANDA
- Marketing start
- 2010-10-06
- Substance
- NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
- Active strength
- .27; 3.15 mg/mL; mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Naphazoline HCI And Pheniramine Maleate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPHAZOLINE HYDROCHLORIDE | .27 mg/mL |
| PHENIRAMINE MALEATE | 3.15 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MZ1131787D, NYW905655B |
| Rxcui | 1043704 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPHAZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | MZ1131787D | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| PHENIRAMINE MALEATE | ACTIVE INGREDIENT | NYW905655B | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| NAPHAZOLINE | ACTIVE MOIETY | H231GF11BV | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| PHENIRAMINE | ACTIVE MOIETY | 134FM9ZZ6M | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | NAPHAZOLINE HCI AND PHENIRAMINE MALEATE (NAPHAZOLINE HYDROCHLORIDE , PHENIRAMINE MALEATE) SOLUTION/ DROPS [ALTAIRE PHARMACEUTICALS INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| 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 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 |
|---|
| 59390-177-13 | 59390017713 | 15 mL in 1 BOTTLE, DROPPER (59390-177-13) | 15 ml | 2010-10-06 | 0000-00-00 | No | No | Current |