8 HR MUSCLE ACHES AND PAIN
- Product NDC
- 51316-354
- 11-digit product format
- 513160354
- Labeler code
- 51316
- Product ID
- 51316-354_33d1710e-b90e-c820-e063-6394a90aaf15
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS Pharmacy
- Application
- ANDA215486
- Marketing category
- ANDA
- Marketing start
- 2025-06-25
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- 8 HR MUSCLE ACHES AND PAIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 650 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 1148399 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-354-42 | 8 HR MUSCLE ACHES AND PAIN | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 2 |
| 51316-354-42 | 8 HR MUSCLE ACHES AND PAIN | 24 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 24 | | 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 |
|---|
| 51316-354-42 | 51316035442 | 1 BOTTLE in 1 CARTON (51316-354-42) / 24 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2025-06-25 | No | No | Historical |