Topcare Ibuprofen PM
- Product NDC
- 36800-050
- 11-digit product format
- 368000050
- Labeler code
- 36800
- Product ID
- 36800-050_ce7b2954-4165-4ca8-902d-8349eea450be
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- diphenhydramine citrate and ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA079113
- Marketing category
- ANDA
- Marketing start
- 2009-02-18
- Substance
- DIPHENHYDRAMINE CITRATE; IBUPROFEN
- Active strength
- 38; 200 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 Ibuprofen PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE CITRATE | 38 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 4OD433S209, WK2XYI10QM |
| Rxcui | 895664 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-050-27 | Topcare Ibuprofen PM | 80 in 1 BOTTLE | TABLET, FILM COATED | 80 | | 8 |
| 36800-050-27 | Topcare Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 36800-050-58 | Topcare Ibuprofen PM | 40 in 1 BOTTLE | TABLET, FILM COATED | 40 | | 8 |
| 36800-050-58 | Topcare Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 36800-050-60 | Topcare Ibuprofen PM | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 8 |
| 36800-050-60 | Topcare Ibuprofen PM | 20 in 1 BOTTLE | TABLET, FILM COATED | 20 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DIPHENHYDRAMINE CITRATE | ACTIVE INGREDIENT | 4OD433S209 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| IBUPROFEN | ACTIVE INGREDIENT | WK2XYI10QM | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| DIPHENHYDRAMINE | ACTIVE MOIETY | 8GTS82S83M | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| IBUPROFEN | ACTIVE MOIETY | WK2XYI10QM | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| GLYCERYL DIBEHENATE | INACTIVE INGREDIENT | R8WTH25YS2 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| POLYVINYL ALCOHOL | INACTIVE INGREDIENT | 532B59J990 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, COATED [TOPCO ASSOCIATES LLC] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-050 | TOPCARE IBUPROFEN PM (DIPHENHYDRAMINE CITRATE AND IBUPROFEN) TABLET, FILM COATED [TOPCO ASSOCIATES LLC] | 8 | Current NDC, Legacy NDC, 6 package rows | 20250423_1435e627-144e-4dc8-9ad6-58d91cbd9094.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 |
|---|
| 36800-050-27 | 36800005027 | 1 BOTTLE in 1 CARTON (36800-050-27) / 80 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2009-02-24 | 0000-00-00 | No | No | Current |
| 36800-050-58 | 36800005058 | 1 BOTTLE in 1 CARTON (36800-050-58) / 40 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2009-02-18 | 0000-00-00 | No | No | Current |
| 36800-050-60 | 36800005060 | 1 BOTTLE in 1 CARTON (36800-050-60) / 20 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2009-02-19 | 0000-00-00 | No | No | Current |