8 hr Pain Relief
- Product NDC
- 55910-895
- 11-digit product format
- 559100895
- Labeler code
- 55910
- Product ID
- 55910-895_f9c35f34-c494-2573-e053-6294a90aee3a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- DOLGENCORP, INC.
- Application
- ANDA215486
- Marketing category
- ANDA
- Marketing start
- 2023-04-29
- 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 Pain Relief
- 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 Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55910-895-05 | 8 hr Pain Relief | 1 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 1 | | 2 |
| 55910-895-05 | 8 hr Pain Relief | 50 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 50 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55910-895 | 8 HR PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [DOLGENCORP, INC.] | 2 | Current NDC, 2 package rows | 20230429_ea2ebb7b-ceab-567a-e053-2995a90aa402.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55910-895-05 | 55910089505 | 1 BOTTLE in 1 BOTTLE (55910-895-05) / 50 TABLET, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2023-04-29 | No | No | Current |