Topcare 8 Hour Pain Relief
- Product NDC
- 36800-369
- 11-digit product format
- 368000369
- Labeler code
- 36800
- Product ID
- 36800-369_c2db19bf-4ebf-4cd8-a6fd-892b50938f17
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- ANDA075077
- Marketing category
- ANDA
- Marketing start
- 2017-04-05
- 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
- Topcare 8 Hour 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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 36800-369-78 | Topcare 8 Hour Pain Relief | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | | 7 |
| 36800-369-78 | Topcare 8 Hour Pain Relief | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 36800-369 | TOPCARE 8 HOUR PAIN RELIEF (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [TOPCO ASSOCIATES LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20250516_38abe710-3d8a-41b0-b057-38c5dfd53322.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 36800-369-78 | 36800036978 | 1 BOTTLE in 1 CARTON (36800-369-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2017-04-05 | 0000-00-00 | No | No | Current |