Ibuprofen and Diphenhydramine HCl
- Product NDC
- 63941-682
- 11-digit product format
- 639410682
- Labeler code
- 63941
- Product ID
- 63941-682_06d3d2fc-a073-863f-e063-6394a90a2374
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- IBUPROFEN, DIPHENHYDRAMINE HCL
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- VALU MERCHANDISERS COMPANY
- Application
- ANDA090397
- Marketing category
- ANDA
- Marketing start
- 2023-10-03
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| TC2D6JAD40 | DIPHENHYDRAMINE HYDROCHLORIDE | 147-24-0 | DIPHENHYDRAMINE HYDROCHLORIDE |
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 63941-682-15 | 63941068215 | 1 BOTTLE in 1 CARTON (63941-682-15) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE | 1 bottle | 2023-10-03 | No | No | Historical |