Guaifenesin 400
- Product NDC
- 57631-012
- 11-digit product format
- 576310012
- Labeler code
- 57631
- Product ID
- 57631-012_4029150e-7782-a118-e063-6294a90a09c1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin Tablets 400
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- InvaTech Pharma Solutions LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2021-01-13
- 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 400
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57631-012-00 | Guaifenesin 400 | 28000 in 1 BOX | TABLET | 28000 | | 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 |
|---|
| 57631-012-00 | 57631001200 | 28000 TABLET in 1 BOX (57631-012-00) | 28000 tablet | 2021-01-13 | No | No | Current |