Guaifenesin
- Product NDC
- 21130-554
- 11-digit product format
- 211300554
- Labeler code
- 21130
- Product ID
- 21130-554_46510bfe-1c72-5f4d-e063-6294a90aa930
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safeway, Inc
- Application
- ANDA213420
- Marketing category
- ANDA
- Marketing start
- 2023-06-30
- Substance
- GUAIFENESIN
- Active strength
- 1200 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 | 1200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 310621 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 21130-554-27 | Guaifenesin | 14 in 1 BLISTER PACK | TABLET | 14 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 21130-554 | GUAIFENESIN TABLET [SAFEWAY, INC] | 5 | Current NDC, 1 package rows | 20241212_f32e5b0f-1fd9-9b33-e053-2995a90a8103.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 21130-554-27 | 21130055427 | 14 TABLET in 1 BLISTER PACK (21130-554-27) | 14 tablet | 2023-06-30 | No | No | Historical |