GUAIFENESIN, DEXTROMETHORPHAN HBR
- Product NDC
- 69729-783
- 11-digit product format
- 697290783
- Labeler code
- 69729
- Product ID
- 69729-783_18aab413-451c-bdd4-e063-6394a90a3eb6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN, DEXTROMETHORPHAN HBR
- Dosage form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Labeler
- OPMX LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-02-18
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 400 mg/1; mg/1
- 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
- GUAIFENESIN, DEXTROMETHORPHAN HBR
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/1 |
| GUAIFENESIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1661740 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69729-783-02 | GUAIFENESIN, DEXTROMETHORPHAN HBR | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | | 5 |
| 69729-783-02 | GUAIFENESIN, DEXTROMETHORPHAN HBR | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69729-783 | GUAIFENESIN, DEXTROMETHORPHAN HBR CAPSULE, LIQUID FILLED [OPMX LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20240518_9a246099-72b5-2efc-e053-2a95a90aafbc.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 |
|---|
| 69729-783-02 | 69729078302 | 2 BLISTER PACK in 1 CARTON (69729-783-02) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2 blister pack | 2019-02-18 | 0000-00-00 | No | No | Current |