8HR Muscle Aches and Pain
- Product NDC
- 81522-201
- 11-digit product format
- 815220201
- Labeler code
- 81522
- Product ID
- 81522-201_1acc0f41-33af-f7b1-e063-6294a90a6385
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- FSA STORE INC.
- Application
- ANDA211544
- Marketing category
- ANDA
- Marketing start
- 2024-03-20
- 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
- 8HR 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 |
|---|
| 81522-201-03 | 8HR Muscle Aches and Pain | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 2 |
| 81522-201-03 | 8HR Muscle Aches and Pain | 100 in 1 BOTTLE, PLASTIC | TABLET, EXTENDED RELEASE | 100 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81522-201 | 8HR MUSCLE ACHES AND PAIN (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [FSA STORE INC.] | 2 | Current NDC, 2 package rows | 20240615_13268603-0080-22cf-e063-6394a90a7db4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81522-201-03 | 81522020103 | 1 BOTTLE, PLASTIC in 1 CARTON (81522-201-03) / 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC | 2024-03-20 | No | No | Historical |