Ibuprofen PM
- Product NDC
- 36800-237
- 11-digit product format
- 368000237
- Labeler code
- 36800
- Product ID
- 36800-237_f0e8a4d9-1a2e-4be2-e053-2995a90a5604
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- TOP CARE (Topco Associates LLC)
- Application
- ANDA090397
- Marketing category
- ANDA
- Marketing start
- 2021-10-15
- Substance
- DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
- Active strength
- 25; 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
- Ibuprofen PM
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DIPHENHYDRAMINE HYDROCHLORIDE | 25 mg/1 |
| IBUPROFEN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TC2D6JAD40, WK2XYI10QM |
| Rxcui | 901814 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-237-15 | Ibuprofen PM | 40 in 1 BOTTLE, PLASTIC | CAPSULE, LIQUID FILLED | 40 | | 3 |
| 36800-237-15 | Ibuprofen PM | 1 in 1 CARTON | CAPSULE, LIQUID FILLED | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-237 | IBUPROFEN PM (IBUPROFEN, DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)] | 3 | Current NDC, Legacy NDC, 2 package rows | 20221229_c62c6319-65eb-37e8-e053-2a95a90a9f90.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-237-15 | 36800023715 | 1 BOTTLE, PLASTIC in 1 CARTON (36800-237-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC | 2021-10-15 | 0000-00-00 | No | No | Current |