DUAL ACTION
- Product NDC
- 42507-540
- 11-digit product format
- 425070540
- Labeler code
- 42507
- Product ID
- 42507-540_c663b8d1-24fa-4e47-8e45-c81492cc6208
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Ibuprofen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- HyVee Inc
- Application
- ANDA214836
- Marketing category
- ANDA
- Marketing start
- 2026-03-18
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 250; 125 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DUAL ACTION
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/1 |
| IBUPROFEN | 125 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, WK2XYI10QM |
| Rxcui | 2387532 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42507-540-23 | DUAL ACTION | 72 in 1 BOTTLE | TABLET, FILM COATED | 72 | | 2 |
| 42507-540-72 | DUAL ACTION | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42507-540-23 | 42507054023 | 72 in 1 BOTTLE | | | | | Historical |
| 42507-540-72 | 42507054072 | 1 BOTTLE in 1 CARTON (42507-540-72) / 72 TABLET, FILM COATED in 1 BOTTLE (42507-540-23) | 1 bottle | 2026-03-18 | No | No | Historical |