EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
- Product NDC
- 50580-446
- 11-digit product format
- 505800446
- Labeler code
- 50580
- Product ID
- 50580-446_3a1abd26-c0a9-8a65-e063-6294a90ab66e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Dextromethorphan Hydrobromide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Kenvue Brands LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-08-26
- Substance
- ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 500; 15 mg/1; mg/1
- 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
- EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 500 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, 9D2RTI9KYH |
| Rxcui | 247324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50580-446-01 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 5 |
| 50580-446-01 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY | 12 in 1 BLISTER PACK | TABLET, FILM COATED | 12 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50580-446 | EXTRA STRENGTH TYLENOL SEVERE COUGH PLUS SORE THROAT DAY (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [KENVUE BRANDS LLC] | 4 | Current NDC, 2 package rows | 20241109_1a17b24a-8022-4e2f-e063-6294a90af276.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 50580-446-01 | 50580044601 | 2 BLISTER PACK in 1 CARTON (50580-446-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2024-08-26 | No | No | Historical |