Childrens Cough and Chest Congestion
- Product NDC
- 69676-0070
- 11-digit product format
- 696760070
- Labeler code
- 69676
- Product ID
- 69676-0070_2d95d5a4-34dd-e195-e063-6394a90a39da
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Genexa Inc.
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2022-09-01
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 5; 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
- Childrens Cough and Chest Congestion
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/5mL |
| GUAIFENESIN | 100 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9D2RTI9KYH, 495W7451VQ |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69676-0070-9 | Childrens Cough and Chest Congestion | 118 mL in 1 BOTTLE | SUSPENSION | 118 | | 1 |
| 69676-0070-9 | Childrens Cough and Chest Congestion | 1 in 1 CARTON | SUSPENSION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69676-0070 | CHILDRENS COUGH AND CHEST CONGESTION (DEXTROMETHORPHAN HBR, GUAIFENESIN) SUSPENSION [GENEXA INC.] | 1 | Current NDC, 2 package rows | 20250210_2d95d5a4-34dc-e195-e063-6394a90a39da.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69676-0070-9 | 69676007009 | 1 BOTTLE in 1 CARTON (69676-0070-9) / 118 mL in 1 BOTTLE | 1 bottle | 2022-09-01 | No | No | Current |