Naproxen Sodium Diphenhydramine HCl
- Product NDC
- 69842-328
- 11-digit product format
- 698420328
- Labeler code
- 69842
- Product ID
- 69842-328_46540a23-aad6-6637-e063-6394a90a569e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- CVS PHARMACY, INC
- Application
- ANDA213663
- Marketing category
- ANDA
- Marketing start
- 2021-05-14
- 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 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69842-328-02 | Naproxen Sodium Diphenhydramine HCl | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 7 |
| 69842-328-08 | Naproxen Sodium Diphenhydramine HCl | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69842-328 | NAPROXEN SODIUM DIPHENHYDRAMINE HCL (NAPROXEN SODIUM DIPHENHYDRAMINE HCL) TABLET, FILM COATED [CVS PHARMACY, INC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241120_bdac694e-ab2a-376d-e053-2a95a90a9467.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69842-328-02 | 69842032802 | 20 TABLET, FILM COATED in 1 BOTTLE (69842-328-02) | 2021-05-14 | 0000-00-00 | No | No | Current |
| 69842-328-08 | 69842032808 | 80 TABLET, FILM COATED in 1 BOTTLE (69842-328-08) | 2021-05-14 | 0000-00-00 | No | No | Current |