GUAIFENESIN
- Product NDC
- 16103-379
- 11-digit product format
- 161030379
- Labeler code
- 16103
- Product ID
- 16103-379_3038393b-2c7b-4f5d-8b5d-d6054f663336
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- GUAIFENESIN
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Pharbest Pharmaceuticals, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-05-01
- 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 |
|---|
| 16103-379-04 | GUAIFENESIN | 1 in 1 CARTON | TABLET | 1 | | 2 |
| 16103-379-04 | GUAIFENESIN | 30 in 1 BOTTLE, PLASTIC | TABLET | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16103-379 | GUAIFENESIN TABLET [PHARBEST PHARMACEUTICALS, INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20210401_0bf70fb4-d3c8-476d-b864-4eadc697a7d8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16103-379-04 | 16103037904 | 1 BOTTLE, PLASTIC in 1 CARTON (16103-379-04) / 30 TABLET in 1 BOTTLE, PLASTIC | 2018-05-01 | 0000-00-00 | No | No | Current |