topcare childrens cold cough
- Product NDC
- 76162-099
- 11-digit product format
- 761620099
- Labeler code
- 76162
- Product ID
- 76162-099_59d16f9e-d90f-4d4d-b5fa-54e2c5dcf159
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- brompheniramine maleate, dextromethorphan hydrobromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Topco Associates LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-06-12
- Substance
- BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 2; 10 mg/10mL; mg/10mL
- 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
- topcare childrens cold cough
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BROMPHENIRAMINE MALEATE | 2 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | IXA7C9ZN03, 9D2RTI9KYH |
| Rxcui | 2683421 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76162-099-26 | topcare childrens cold cough | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
| 76162-099-26 | topcare childrens cold cough | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76162-099-26 | 76162009926 | 1 BOTTLE in 1 CARTON (76162-099-26) / 118 mL in 1 BOTTLE | 1 bottle | 2025-06-12 | No | No | Historical |