Infants TYLENOL
- Product NDC
- 50580-154
- 11-digit product format
- 505800154
- Labeler code
- 50580
- Product ID
- 50580-154_4a121ba1-d91e-0039-e063-6294a90a5445
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-04-13
- Substance
- ACETAMINOPHEN
- Active strength
- 160 mg/5mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Infants TYLENOL
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 160 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D |
| Rxcui | 307668, 828555 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-154-02 | Infants TYLENOL | 60 mL in 1 BOTTLE | SUSPENSION | 60 | | 1 |
| 50580-154-02 | Infants TYLENOL | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-154-02 | 50580015402 | 1 BOTTLE in 1 CARTON (50580-154-02) / 60 mL in 1 BOTTLE | 1 bottle | 2026-04-13 | No | No | Current |