Ibuprofen PM
- Product NDC
- 55319-197
- 11-digit product format
- 553190197
- Labeler code
- 55319
- Product ID
- 55319-197_bf93acc7-e377-45cc-b9f4-269b516e0c6a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Citrate, Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Family Dollar (FAMILY WELLNESS)
- Application
- ANDA211404
- Marketing category
- ANDA
- Marketing start
- 2024-03-01
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 4OD433S209 | DIPHENHYDRAMINE CITRATE | 88637-37-0 | DIPHENHYDRAMINE CITRATE |
| WK2XYI10QM | IBUPROFEN | 15687-27-1 | IBUPROFEN |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55319-197-20 | 55319019720 | 1 BOTTLE, PLASTIC in 1 BOX (55319-197-20) / 20 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-03-01 | No | No | Historical |
| 55319-197-40 | 55319019740 | 1 BOTTLE, PLASTIC in 1 BOX (55319-197-40) / 40 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-03-01 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Drug Facts | Family Dollar (FAMILY WELLNESS) | 2025-10-22 | HUMAN OTC DRUG LABEL | 7 |
| Drug Facts | Family Dollar (FAMILY WELLNESS) | 2023-11-15 | HUMAN OTC DRUG LABEL | 6 |