topcare all night pain relief pm
- Product NDC
- 36800-264
- 11-digit product format
- 368000264
- Labeler code
- 36800
- Product ID
- 36800-264_32352610-bdfc-40f5-8d85-daa6fc9f7ae4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine hydrochloride, naproxen sodium
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA208499
- Marketing category
- ANDA
- Marketing start
- 2019-08-08
- 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
- topcare all night pain relief 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 |
|---|
| 36800-264-27 | topcare all night pain relief pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
| 36800-264-27 | topcare all night pain relief pm | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 6 |
| 36800-264-60 | topcare all night pain relief pm | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 6 |
| 36800-264-60 | topcare all night pain relief pm | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-264 | TOPCARE ALL NIGHT PAIN RELIEF PM (DIPHENHYDRAMINE HYDROCHLORIDE, NAPROXEN SODIUM) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 5 | Current NDC, Legacy NDC, 4 package rows | 20231213_a20f193e-4e64-400a-b605-df08026cb80b.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 |
|---|
| 36800-264-27 | 36800026427 | 1 BOTTLE in 1 CARTON (36800-264-27) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-08-12 | 0000-00-00 | No | No | Current |
| 36800-264-60 | 36800026460 | 1 BOTTLE in 1 CARTON (36800-264-60) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-08-08 | 0000-00-00 | No | No | Current |