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NDC 52412-0992-01 Pediacare Childrens Cough and Congestion Grape 5; 100 mg/5mL; mg/5mL Details
Pediacare Childrens Cough and Congestion Grape 5; 100 mg/5mL; mg/5mL
Pediacare Childrens Cough and Congestion Grape is a ORAL SYRUP in the HUMAN OTC DRUG category. It is labeled and distributed by RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH. The primary component is DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN.
Product Information
| NDC | 52412-0992 |
|---|---|
| Product ID | 52412-992_caf8e909-90c3-4c17-aebd-6430d23ef53f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Pediacare Childrens Cough and Congestion Grape |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SYRUP |
| Route | ORAL |
| Active Ingredient Strength | 5; 100 |
| Active Ingredient Units | mg/5mL; mg/5mL |
| Substance Name | DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN |
| Labeler Name | RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH |
| Pharmaceutical Class | 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 Ant |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 52412-0992-01 (52412099201)
| NDC Package Code | 52412-992-01 |
|---|---|
| Billing NDC | 52412099201 |
| Package | 1 BOTTLE in 1 CARTON (52412-992-01) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2023-01-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |