equaline naproxen sodium pm
- Product NDC
- 41163-593
- 11-digit product format
- 411630593
- Labeler code
- 41163
- Product ID
- 41163-593_26bb9c64-c1af-409a-852e-3b2084de8b6a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride, naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- United Natural Foods, Inc. dba UNFI
- Application
- ANDA208499
- Marketing category
- ANDA
- Marketing start
- 2019-12-17
- 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
- equaline 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 |
|---|
| 41163-593-58 | equaline naproxen sodium pm | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 6 |
| 41163-593-58 | equaline naproxen sodium pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 41163-593-71 | equaline naproxen sodium pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 41163-593-71 | equaline naproxen sodium pm | 50 in 1 BOTTLE | TABLET, FILM COATED | 50 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 41163-593 | EQUALINE NAPROXEN SODIUM PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI] | 5 | Current NDC, Legacy NDC, 4 package rows | 20230822_ed7bfa3f-4972-4ab6-9f0c-0873a11571a9.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 |
|---|
| 41163-593-58 | 41163059358 | 1 BOTTLE in 1 CARTON (41163-593-58) > 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-12-17 | 0000-00-00 | No | No | Current |
| 41163-593-71 | 41163059371 | 1 BOTTLE in 1 CARTON (41163-593-71) / 50 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2022-03-25 | 0000-00-00 | No | No | Current |