Childrens TYLENOL
- Product NDC
- 50580-194
- 11-digit product format
- 505800194
- Labeler code
- 50580
- Product ID
- 50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Dextromethorphan Hydrobromide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-26
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 160; 5 mg/5mL; mg/5mL
- Pharmacologic classes
- Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Childrens TYLENOL
- Brand name suffix
- COLD PLUS COUGH PLUS SORE THROAT
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 160 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 1370113 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-194-01 | Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 6 |
| 50580-194-01 | Childrens TYLENOLCOLD PLUS COUGH PLUS SORE THROAT | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-194 | CHILDRENS TYLENOL COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [KENVUE BRANDS LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241109_e83f7911-22b4-4ffc-8f49-68f6acd2ebf5.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 |
|---|
| 50580-194-01 | 50580019401 | 1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE | 1 bottle | 2017-06-26 | 0000-00-00 | No | No | Current |