Premier Value
- Product NDC
- 68016-744
- 11-digit product format
- 680160744
- Labeler code
- 68016
- Product ID
- 68016-744_f347f2e4-1b55-4086-b20b-e9bc75e8e678
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PHARMACY VALUE ALLIANCE LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2019-03-20
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20; 200 mg/20mL; mg/20mL
- 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
- Premier Value
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 20 mg/20mL |
| GUAIFENESIN | 200 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 1790650 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68016-744-04 | Premier Value | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 6 |
| 68016-744-04 | Premier Value | 1 in 1 CARTON | SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68016-744 | PREMIER VALUE (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [PHARMACY VALUE ALLIANCE LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20241030_1ae3c6ac-1646-4c67-a9d5-9c383924b81a.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 |
|---|
| 68016-744-04 | 68016074404 | 1 BOTTLE in 1 CARTON (68016-744-04) / 118 mL in 1 BOTTLE | 1 bottle | 2019-03-20 | 0000-00-00 | No | No | Current |