Naproxen Sodium and Diphenhydramine HCl
- Product NDC
- 62207-814
- 11-digit product format
- 622070814
- Labeler code
- 62207
- Product ID
- 62207-814_3b4ca636-ecbd-6807-e063-6294a90a7765
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naproxen Sodium and Diphenhydramine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Granules India Ltd
- Application
- ANDA213663
- Marketing category
- ANDA
- Marketing start
- 2021-02-20
- 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 |
|---|
| 62207-814-38 | Naproxen Sodium and Diphenhydramine HCl | 37500 in 1 POUCH | TABLET, FILM COATED | 37500 | | 5 |
| 62207-814-39 | Naproxen Sodium and Diphenhydramine HCl | 7500 in 1 POUCH | TABLET, FILM COATED | 7500 | | 5 |
| 62207-814-47 | Naproxen Sodium and Diphenhydramine HCl | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 5 |
| 62207-814-95 | Naproxen Sodium and Diphenhydramine HCl | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 5 |
| 62207-814-95 | Naproxen Sodium and Diphenhydramine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62207-814 | NAPROXEN SODIUM AND DIPHENHYDRAMINE HCL TABLET, FILM COATED [GRANULES INDIA LTD] | 4 | Current NDC, Legacy NDC, 5 package rows | 20230210_0d59780a-ef22-4b67-8b42-9795dbec8db0.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 |
|---|
| 62207-814-38 | 62207081438 | 37500 TABLET, FILM COATED in 1 POUCH (62207-814-38) | | 2021-02-20 | 0000-00-00 | No | No | Current |
| 62207-814-39 | 62207081439 | 7500 TABLET, FILM COATED in 1 POUCH (62207-814-39) | | 2021-02-20 | 0000-00-00 | No | No | Current |
| 62207-814-47 | 62207081447 | 500 TABLET, FILM COATED in 1 BOTTLE (62207-814-47) | | 2021-02-20 | 0000-00-00 | No | No | Current |
| 62207-814-95 | 62207081495 | 1 BOTTLE in 1 CARTON (62207-814-95) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2021-02-20 | 0000-00-00 | No | No | Current |