Guaifenesin and Codeine Phosphate
- Product NDC
- 0121-0775
- 11-digit product format
- 001210775
- Labeler code
- 0121
- Product ID
- 0121-0775_2175415b-f07e-50a6-e063-6394a90acabe
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Guaifenesin and Codeine Phosphate
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- PAI Holdings, LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2006-10-01
- 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
- Guaifenesin and Codeine Phosphate
- 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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0121-0775-04 | Guaifenesin and Codeine Phosphate | 118 mL in 1 BOTTLE | SOLUTION | 118 | | 11 |
| 0121-0775-08 | Guaifenesin and Codeine Phosphate | 237 mL in 1 BOTTLE | SOLUTION | 237 | | 11 |
| 0121-0775-16 | Guaifenesin and Codeine Phosphate | 473 mL in 1 BOTTLE | SOLUTION | 473 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| CODEINE PHOSPHATE | ACTIVE INGREDIENT | GSL05Y1MN6 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| Codeine Phosphate | ACTIVE INGREDIENT | GSL05Y1MN6 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| Codeine | ACTIVE MOIETY | Q830PW7520 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| CODEINE ANHYDROUS | ACTIVE MOIETY | UX6OWY2V7J | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| edetate disodium | INACTIVE INGREDIENT | 7FLD91C86K | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| FD&C Blue No. 1 | INACTIVE INGREDIENT | H3R47K3TBD | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| FD&C Red No. 40 | INACTIVE INGREDIENT | WZB9127XOA | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [A-S MEDICATION SOLUTIONS LLC] | 1 | |
| FD&C Yellow No. 6 | INACTIVE INGREDIENT | H77VEI93A8 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| menthol | INACTIVE INGREDIENT | L7T10EIP3A | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| menthol | INACTIVE INGREDIENT | L7T10EIP3A | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| propylene glycol | INACTIVE INGREDIENT | 6DC9Q167V3 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| sodium benzoate | INACTIVE INGREDIENT | OJ245FE5EU | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sodium citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
| sorbitol | INACTIVE INGREDIENT | 506T60A25R | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DIRECTRX] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [DISPENSING SOLUTIONS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0121-0775 | GUAIFENESIN AND CODEINE PHOSPHATE SOLUTION [PAI HOLDINGS, LLC] | 11 | Current NDC, Legacy NDC, 3 package rows | 20240907_88d0994c-4270-4408-8837-bd97510b2118.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 |
|---|
| 0121-0775-04 | 00121077504 | 118 mL in 1 BOTTLE (0121-0775-04) | 118 ml | 2006-10-01 | 0000-00-00 | No | No | Current |
| 0121-0775-08 | 00121077508 | 237 mL in 1 BOTTLE (0121-0775-08) | 237 ml | 2006-10-01 | 0000-00-00 | No | No | Current |
| 0121-0775-16 | 00121077516 | 473 mL in 1 BOTTLE (0121-0775-16) | 473 ml | 2006-10-01 | 0000-00-00 | No | No | Current |