NAPROXEN SODIUM PM
- Product NDC
- 21130-639
- 11-digit product format
- 211300639
- Labeler code
- 21130
- Product ID
- 21130-639_f966deeb-c8cb-484a-96f7-678e755bc8ab
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride, naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Safeway
- Application
- ANDA208499
- Marketing category
- ANDA
- Marketing start
- 2025-03-13
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
- Active strength
- 25; 220 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- NAPROXEN SODIUM PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| NAPROXEN SODIUM | 220 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40, 9TN87S3A3C |
| Rxcui | 1550957 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21130-639-71 | NAPROXEN SODIUM PM | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 2 |
| 21130-639-71 | NAPROXEN SODIUM PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21130-639-71 | 21130063971 | 1 BOTTLE in 1 CARTON (21130-639-71) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2025-03-13 | No | No | Historical |