Leader Childrens Cold and Cough
- Product NDC
- 70000-0715
- 11-digit product format
- 700000715
- Labeler code
- 70000
- Product ID
- 70000-0715_d6f60235-73ff-4ebe-9940-c21f8dd2b3c5
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- brompheniramine maleate, dextromethorphan hydrobromide
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Cardinal Health 110, LLC. dba Leader
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-01-06
- 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
- Leader Childrens Cold and 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 |
|---|
| 70000-0715-1 | Leader Childrens Cold and Cough | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 2 |
| 70000-0715-1 | Leader Childrens Cold and Cough | 1 in 1 CARTON | SOLUTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0715 | LEADER CHILDRENS COLD AND COUGH (BROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [CARDINAL HEALTH 110, LLC. DBA LEADER] | 2 | Current NDC, 2 package rows | 20250110_207b2677-aaad-4fe4-a96d-963b7dcfba70.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 |
|---|
| 70000-0715-1 | 70000071501 | 1 BOTTLE in 1 CARTON (70000-0715-1) / 118 mL in 1 BOTTLE | 1 bottle | 2025-01-06 | No | No | Historical |