SafeTynadol
- Product NDC
- 81389-001
- 11-digit product format
- 813890001
- Labeler code
- 81389
- Product ID
- 81389-001_08c11030-7b99-55ae-e063-6394a90a1437
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Sinew Pharma Inc.
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-21
- Substance
- ACETAMINOPHEN
- Active strength
- 500 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
- SafeTynadol
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 198440 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81389-001-01 | SafeTynadol | 200 in 1 BOTTLE | TABLET, COATED | 200 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81389-001 | SAFETYNADOL (ACETAMINOPHEN) TABLET, COATED [SINEW PHARMA INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20231030_b956d527-7ea7-e084-e053-2a95a90a866d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81389-001-01 | 81389000101 | 200 TABLET, COATED in 1 BOTTLE (81389-001-01) | 2021-01-21 | 0000-00-00 | No | No | Current |