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NDC 63824-0744-36 Cepacol 7.5; 5 mg/1; mg/1 Details
Cepacol 7.5; 5 mg/1; mg/1
Cepacol is a ORAL LOZENGE in the HUMAN OTC DRUG category. It is labeled and distributed by RB Health (US) LLC. The primary component is BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE.
Product Information
| NDC | 63824-0744 |
|---|---|
| Product ID | 63824-744_0650e5e8-1241-6c92-e063-6394a90ac9c0 |
| Associated GPIs | 88209902204725 |
| GCN Sequence Number | 063802 |
| GCN Sequence Number Description | dextromethorphan/benzocaine LOZENGE 5MG-7.5MG ORAL |
| HIC3 | H6C |
| HIC3 Description | ANTITUSSIVES, NON-OPIOID |
| GCN | 99512 |
| HICL Sequence Number | 001911 |
| HICL Sequence Number Description | DEXTROMETHORPHAN HBR/BENZOCAINE |
| Brand/Generic | Brand |
| Proprietary Name | Cepacol |
| Proprietary Name Suffix | Extra Strength Sore Throat and Cough |
| Non-Proprietary Name | BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 7.5; 5 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Standardized Chemical Allergen [EPC], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA R |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63824-0744-36 (63824074436)
| NDC Package Code | 63824-744-36 |
|---|---|
| Billing NDC | 63824074436 |
| Package | 3 BLISTER PACK in 1 CARTON (63824-744-36) / 12 LOZENGE in 1 BLISTER PACK |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |