Childrens TYLENOL
- Product NDC
- 50580-299
- 11-digit product format
- 505800299
- Labeler code
- 50580
- Product ID
- 50580-299_21e6aa92-576f-0f36-e063-6394a90a0c69
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-06-26
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 160; 1; 5; 2.5 mg/5mL; mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- 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 FLU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 160 mg/5mL |
| CHLORPHENIRAMINE MALEATE | 1 mg/5mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| PHENYLEPHRINE HYDROCHLORIDE | 2.5 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1113397 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-299-01 | Childrens TYLENOLCOLD Plus FLU | 1 in 1 CARTON | SUSPENSION | 1 | | 6 |
| 50580-299-01 | Childrens TYLENOLCOLD Plus FLU | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-299 | CHILDRENS TYLENOL COLD PLUS FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) SUSPENSION [KENVUE BRANDS LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241109_8b516736-86ac-47cb-a0ec-038d4c3a0020.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 |
|---|
| 50580-299-01 | 50580029901 | 1 BOTTLE in 1 CARTON (50580-299-01) / 120 mL in 1 BOTTLE | 1 bottle | 2017-06-26 | 0000-00-00 | No | No | Current |