careone naproxen sodium pm
- Product NDC
- 41520-264
- 11-digit product format
- 415200264
- Labeler code
- 41520
- Product ID
- 41520-264_65baf60d-f7f4-4482-a7a4-3aab220925e2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride, naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Sales Company
- Application
- ANDA208499
- Marketing category
- ANDA
- Marketing start
- 2020-02-25
- 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
- careone 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 |
|---|
| 41520-264-27 | careone naproxen sodium pm | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 4 |
| 41520-264-27 | careone naproxen sodium pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
| 41520-264-60 | careone naproxen sodium pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 4 |
| 41520-264-60 | careone naproxen sodium pm | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41520-264 | CAREONE NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [AMERICAN SALES COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20231213_16547905-59c0-4936-82e1-2d9f5935d8dd.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 |
|---|
| 41520-264-27 | 41520026427 | 1 BOTTLE in 1 CARTON (41520-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-02-25 | 0000-00-00 | No | No | Current |
| 41520-264-60 | 41520026460 | 1 BOTTLE in 1 CARTON (41520-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2020-02-25 | 0000-00-00 | No | No | Current |