Naproxen Sodium and Diphenhydramine HCl
- Product NDC
- 69238-1422
- 11-digit product format
- 692381422
- Labeler code
- 69238
- Product ID
- 69238-1422_b9db3e35-7654-4bf3-8536-38f56b8780c7
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium and Diphenhydramine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals NY LLC
- Application
- ANDA209726
- Marketing category
- ANDA
- Marketing start
- 2018-10-23
- 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 and Diphenhydramine HCl
- 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 |
|---|
| 69238-1422-2 | Naproxen Sodium and Diphenhydramine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 69238-1422-2 | Naproxen Sodium and Diphenhydramine HCl | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 69238-1422-4 | Naproxen Sodium and Diphenhydramine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 69238-1422-4 | Naproxen Sodium and Diphenhydramine HCl | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 6 |
| 69238-1422-6 | Naproxen Sodium and Diphenhydramine HCl | 160 in 1 BOTTLE | TABLET, FILM COATED | 160 | | 6 |
| 69238-1422-6 | Naproxen Sodium and Diphenhydramine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 69238-1422-8 | Naproxen Sodium and Diphenhydramine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 69238-1422-8 | Naproxen Sodium and Diphenhydramine HCl | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69238-1422 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL (NAPROXEN SODIUM AND DIPHENHYDRAMINE) TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC] | 6 | Current NDC, Legacy NDC, 8 package rows | 20231231_caca14cf-95f2-4c60-8bba-2154b8f353a3.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 |
|---|
| 69238-1422-2 | 69238142202 | 1 BOTTLE in 1 CARTON (69238-1422-2) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-10-23 | 0000-00-00 | No | No | Current |
| 69238-1422-4 | 69238142204 | 1 BOTTLE in 1 CARTON (69238-1422-4) / 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-10-23 | 0000-00-00 | No | No | Current |
| 69238-1422-6 | 69238142206 | 1 BOTTLE in 1 CARTON (69238-1422-6) / 160 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-10-23 | 0000-00-00 | No | No | Current |
| 69238-1422-8 | 69238142208 | 1 BOTTLE in 1 CARTON (69238-1422-8) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2018-10-23 | 0000-00-00 | No | No | Current |