Codeine-Guaifenesin
- Product NDC
- 69367-272
- 11-digit product format
- 693670272
- Labeler code
- 69367
- Product ID
- 69367-272_82e575e8-9a6e-432e-8991-8f640de01dd6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Codeine Phosphate and Guaifenesin
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Westminster Pharmaceuticals, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2020-07-15
- Substance
- CODEINE PHOSPHATE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Full Opioid Agonists [MoA], Increased Respiratory Secretions [PE], Opioid Agonist [EPC]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Codeine-Guaifenesin
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CODEINE PHOSPHATE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | GSL05Y1MN6, 495W7451VQ |
| Rxcui | 995868 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69367-272-04 | Codeine-Guaifenesin | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 6 |
| 69367-272-16 | Codeine-Guaifenesin | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69367-272 | CODEINE-GUAIFENESIN (CODEINE PHOSPHATE AND GUAIFENESIN) SOLUTION [WESTMINSTER PHARMACEUTICALS, LLC] | 6 | Current NDC, Legacy NDC, 2 package rows | 20250515_3da3efd7-e278-4d79-9130-eef3992097e4.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 |
|---|
| 69367-272-04 | 69367027204 | 118 mL in 1 BOTTLE (69367-272-04) | 118 ml | 2020-07-15 | 0000-00-00 | No | No | Current |
| 69367-272-16 | 69367027216 | 473 mL in 1 BOTTLE (69367-272-16) | 473 ml | 2020-07-15 | 0000-00-00 | No | No | Current |