Ibuprofen PM
- Product NDC
- 69607-1970
- 11-digit product format
- 696071970
- Labeler code
- 69607
- Product ID
- 69607-1970_53818277-b127-4271-9604-8015eacd6c99
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Diphenhydramine Citrate, Ibuprofen
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- WR Group, Inc.
- Application
- ANDA211404
- Marketing category
- ANDA
- Marketing start
- 2025-02-28
- 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
- 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 |
|---|
| 69607-1970-1 | Ibuprofen PM | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | | 2 |
| 69607-1970-1 | Ibuprofen PM | 1 in 1 BOX | TABLET, COATED | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69607-1970 | IBUPROFEN PM (DIPHENHYDRAMINE CITRATE, IBUPROFEN) TABLET, COATED [WR GROUP, INC.] | 2 | Current NDC, 2 package rows | 20250327_1e2feaf0-7fff-43d5-bcfe-9f2851bdc805.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 69607-1970-1 | 69607197001 | 1 BOTTLE, PLASTIC in 1 BOX (69607-1970-1) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC | 2025-02-28 | No | No | Historical |