Guaifenesin
- Product NDC
- 0904-5154
- 11-digit product format
- 009045154
- Labeler code
- 0904
- Product ID
- 0904-5154_cec9f1e6-0f50-44af-866c-d87f8f8975d1
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Major Pharmaceuticals
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2009-10-05
- Substance
- GUAIFENESIN
- Active strength
- 200 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
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GUAIFENESIN | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0904-5154-60 | Guaifenesin | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 13 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| MALTODEXTRIN | INACTIVE INGREDIENT | 7CVR7L4A2D | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUAIFENESIN TABLET [CONTRACT PHARMACY SERVICES-PA] | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | GUAIFENESIN TABLET [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0904-5154 | GUAIFENESIN TABLET [MAJOR PHARMACEUTICALS] | 25 | Current NDC, Legacy NDC, 1 package rows | 20250512_aa662428-e61f-4e22-af4d-8cf63df68c99.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 |
|---|
| 0904-5154-60 | 00904515460 | 100 TABLET in 1 BOTTLE, PLASTIC (0904-5154-60) | 100 tablet | 2009-10-05 | 0000-00-00 | No | No | Current |