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NDC 63824-0713-94 Cepacol 15; 3.6 mg/1; mg/1 Details
Cepacol 15; 3.6 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; MENTHOL, UNSPECIFIED FORM.
Product Information
| NDC | 63824-0713 |
|---|---|
| Product ID | 63824-713_065149c7-3edf-b6ee-e063-6394a90a93a7 |
| Associated GPIs | 88359902154795 |
| GCN Sequence Number | 067735 |
| GCN Sequence Number Description | benzocaine/menthol LOZENGE 15MG-3.6MG MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 30354 |
| HICL Sequence Number | 001675 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL |
| Brand/Generic | Brand |
| Proprietary Name | Cepacol |
| Proprietary Name Suffix | Extra Strength Sore Throat cherry |
| Non-Proprietary Name | Benzocaine and Menthol |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LOZENGE |
| Route | ORAL |
| Active Ingredient Strength | 15; 3.6 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | BENZOCAINE; MENTHOL, UNSPECIFIED FORM |
| Labeler Name | RB Health (US) LLC |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63824-0713-94 (63824071394)
| NDC Package Code | 63824-713-94 |
|---|---|
| Billing NDC | 63824071394 |
| Package | 1 BLISTER PACK in 1 CARTON (63824-713-94) / 4 LOZENGE in 1 BLISTER PACK |
| Marketing Start Date | 2013-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |