Dextromethorphan HBr and Guaifenesin Oral Solution
- Product NDC
- 81033-103
- 11-digit product format
- 810330103
- Labeler code
- 81033
- Product ID
- 81033-103_2cee75e1-ee97-6129-e063-6394a90a03dd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr and Guaifenesin Oral Solution
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- KESIN PHARMA CORPORATION
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-12-02
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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
- Dextromethorphan HBr and Guaifenesin Oral Solution
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 996520 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 81033-103-05 | Dextromethorphan HBr and Guaifenesin Oral Solution | 5 mL in 1 CUP, UNIT-DOSE | LIQUID | 5 | | 3 |
| 81033-103-10 | Dextromethorphan HBr and Guaifenesin Oral Solution | 10 mL in 1 CUP, UNIT-DOSE | LIQUID | 10 | | 3 |
| 81033-103-50 | Dextromethorphan HBr and Guaifenesin Oral Solution | 100 in 1 CASE | LIQUID | 100 | | 3 |
| 81033-103-51 | Dextromethorphan HBr and Guaifenesin Oral Solution | 100 in 1 CASE | LIQUID | 100 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81033-103 | DEXTROMETHORPHAN HBR AND GUAIFENESIN ORAL SOLUTION LIQUID [KESIN PHARMA CORPORATION] | 3 | Current NDC, 4 package rows | 20250131_284eae44-81bc-400c-e063-6394a90af446.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 |
|---|
| 81033-103-05 | 81033010305 | 5 mL in 1 CUP, UNIT-DOSE | 5 ml | | | | Historical |
| 81033-103-10 | 81033010310 | 10 mL in 1 CUP, UNIT-DOSE | 10 ml | | | | Historical |
| 81033-103-50 | 81033010350 | 100 CUP, UNIT-DOSE in 1 CASE (81033-103-50) / 5 mL in 1 CUP, UNIT-DOSE (81033-103-05) | | 2024-12-02 | No | No | Current |
| 81033-103-51 | 81033010351 | 100 CUP, UNIT-DOSE in 1 CASE (81033-103-51) / 10 mL in 1 CUP, UNIT-DOSE (81033-103-10) | | 2024-12-02 | No | No | Current |