GUAIFENESIN
- Product NDC
- 51316-071
- 11-digit product format
- 513160071
- Labeler code
- 51316
- Product ID
- 51316-071_c84bf7a4-0567-4d1c-bcaa-976de2a31ff4
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- guaifenesin
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- CVS
- Application
- ANDA209254
- Marketing category
- ANDA
- Marketing start
- 2022-10-07
- Substance
- GUAIFENESIN
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 495W7451VQ |
| Rxcui | 636522 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51316-071-68 | GUAIFENESIN | 68 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 68 | | 2 |
| 51316-071-68 | GUAIFENESIN | 1 in 1 CARTON | TABLET, EXTENDED RELEASE | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51316-071 | GUAIFENESIN TABLET, EXTENDED RELEASE [CVS] | 2 | Current NDC, Legacy NDC, 2 package rows | 20221209_4efa8bf9-3394-47b4-b630-9476b15d2dfc.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 |
|---|
| 51316-071-68 | 51316007168 | 1 BLISTER PACK in 1 CARTON (51316-071-68) / 68 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 blister pack | 2022-10-07 | 0000-00-00 | No | No | Current |