Guaifenesin
- Product NDC
- 71679-309
- 11-digit product format
- 716790309
- Labeler code
- 71679
- Product ID
- 71679-309_45395c54-4eb3-fd26-e063-6294a90a9f93
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Health Pharma USA LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-07
- Substance
- GUAIFENESIN
- Active strength
- 400 mg/1
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 400 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 359601 |
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 |
|---|
| 71679-309-00 | Guaifenesin | 38500 in 1 BOTTLE | TABLET | 38500 | | 5 |
| 71679-309-02 | Guaifenesin | 200 in 1 BOTTLE | TABLET | 200 | | 5 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71679-309-00 | 71679030900 | 38500 TABLET in 1 BOTTLE (71679-309-00) | 38500 tablet | 2024-03-07 | No | No | Current |
| 71679-309-02 | 71679030902 | 200 TABLET in 1 BOTTLE (71679-309-02) | 200 tablet | 2024-02-07 | No | No | Current |