Cosedal Drops
- Product NDC
- 53145-059
- 11-digit product format
- 531450059
- Labeler code
- 53145
- Product ID
- 53145-059_3a8a3022-d085-1ccf-e063-6394a90a90ed
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBR, Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Menper Distributors, Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2012-02-21
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 10; 100 mg/5mL; mg/5mL
- Pharmacologic classes
- Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cosedal Drops
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 10 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
| Rxcui | 996520 |
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 |
|---|
| 53145-059-02 | Cosedal Drops | 60 mL in 1 BOTTLE, DROPPER | LIQUID | 60 | | 6 |
| 53145-059-02 | Cosedal Drops | 1 in 1 CARTON | LIQUID | 1 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| CITRIC ACID ACETATE | INACTIVE INGREDIENT | DSO12WL7AU | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| D&C RED NO. 33 | INACTIVE INGREDIENT | 9DBA0SBB0L | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| RASPBERRY | INACTIVE INGREDIENT | 4N14V5R27W | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| SUCROSE | INACTIVE INGREDIENT | C151H8M554 | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | COSEDAL DROPS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [MENPER DISTRIBUTORS, INC.] | 3 | |
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 |
|---|
| 53145-059-02 | 53145005902 | 1 BOTTLE, DROPPER in 1 CARTON (53145-059-02) / 60 mL in 1 BOTTLE, DROPPER | 2012-02-21 | 0000-00-00 | No | No | Current |