Pediacare Childrens Cough and Congestion Grape
- Product NDC
- 52412-992
- 11-digit product format
- 524120992
- Labeler code
- 52412
- Product ID
- 52412-992_2a815f27-d222-bc77-e063-6294a90a5f7a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2023-01-03
- 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
- Pediacare Childrens Cough and Congestion Grape
- 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 |
| Rxcui | 1020138 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52412-992-01 | Pediacare Childrens Cough and Congestion Grape | 118 mL in 1 BOTTLE | SYRUP | 118 | | 2 |
| 52412-992-01 | Pediacare Childrens Cough and Congestion Grape | 1 in 1 CARTON | SYRUP | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52412-992 | PEDIACARE CHILDRENS COUGH AND CONGESTION GRAPE (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SYRUP [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250101_9576723b-748c-45e7-bc0d-cc109b9f6735.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 |
|---|
| 52412-992-01 | 52412099201 | 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE | 1 bottle | 2023-01-03 | 0000-00-00 | No | No | Current |