CVS Childrens
- Product NDC
- 51316-650
- 11-digit product format
- 513160650
- Labeler code
- 51316
- Product ID
- 51316-650_458236aa-1166-a8cf-e063-6394a90aaab5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen and Dextromethorphan Hydrobromide
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- CVS PHARMACY
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-02-01
- 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
- CVS Childrens
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-650-04 | CVS ChildrensCOLD PLUS COUGH PLUS SORE THROAT | 120 mL in 1 BOTTLE | SUSPENSION | 120 | | 3 |
| 51316-650-04 | CVS ChildrensCOLD PLUS COUGH PLUS SORE THROAT | 1 in 1 CARTON | SUSPENSION | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-650 | CVS CHILDRENS COLD PLUS COUGH PLUS SORE THROAT (ACETAMINOPHEN AND DEXTROMETHORPHAN HYDROBROMIDE) SUSPENSION [CVS PHARMACY] | 2 | Current NDC, 2 package rows | 20240326_27820bce-6638-4f17-ac66-62b02b76bec3.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 |
|---|
| 51316-650-04 | 51316065004 | 1 BOTTLE in 1 CARTON (51316-650-04) / 120 mL in 1 BOTTLE | 1 bottle | 2023-02-01 | No | No | Current |