Cough and Cold HBP
- Product NDC
- 50844-689
- 11-digit product format
- 508440689
- Labeler code
- 50844
- Product ID
- 50844-689_eda8099c-cbbf-4aa3-9142-fbb7a700901b
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Chlorpheniramine maleate, Dextromethorphan HBr
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- L.N.K. International, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-05-15
- Substance
- CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 4; 30 mg/1; mg/1
- Pharmacologic classes
- 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]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cough and Cold HBP
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CHLORPHENIRAMINE MALEATE | 4 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | V1Q0O9OJ9Z, 9D2RTI9KYH |
| Rxcui | 1421985 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50844-689-21 | Cough and Cold HBP | 2 in 1 CARTON | TABLET, FILM COATED | 2 | | 12 |
| 50844-689-21 | Cough and Cold HBP | 8 in 1 BLISTER PACK | TABLET, FILM COATED | 8 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50844-689 | COUGH AND COLD HBP (CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] | 10 | Current NDC, Legacy NDC, 2 package rows | 20240921_9f2daffc-1904-4d64-9f84-689c88601e06.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 |
|---|
| 50844-689-21 | 50844068921 | 2 BLISTER PACK in 1 CARTON (50844-689-21) / 8 TABLET, FILM COATED in 1 BLISTER PACK | 2 blister pack | 2017-05-15 | 0000-00-00 | No | No | Current |