Cepacol
- Product NDC
- 63824-713
- 11-digit product format
- 638240713
- Labeler code
- 63824
- Product ID
- 63824-713_51a69c7a-3f79-01bc-e063-6394a90adcaa
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine and Menthol
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-15
- Substance
- BENZOCAINE; MENTHOL, UNSPECIFIED FORM
- Active strength
- 15; 3.6 mg/1; mg/1
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Cepacol
- Brand name suffix
- Extra Strength Sore Throat cherry
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 15 mg/1 |
| MENTHOL, UNSPECIFIED FORM | 3.6 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5, L7T10EIP3A |
| Rxcui | 824574, 1235477 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63824-713-04 | CepacolExtra Strength Sore Throat cherry | 4 in 1 BLISTER PACK | LOZENGE | 4 | | 11 |
| 63824-713-04 | CepacolExtra Strength Sore Throat cherry | 1 in 1 CARTON | LOZENGE | 1 | | 11 |
| 63824-713-16 | CepacolExtra Strength Sore Throat cherry | 8 in 1 BLISTER PACK | LOZENGE | 8 | | 11 |
| 63824-713-16 | CepacolExtra Strength Sore Throat cherry | 2 in 1 CARTON | LOZENGE | 2 | | 11 |
| 63824-713-94 | CepacolExtra Strength Sore Throat cherry | 1 in 1 CARTON | LOZENGE | 1 | | 11 |
| 63824-713-94 | CepacolExtra Strength Sore Throat cherry | 4 in 1 BLISTER PACK | LOZENGE | 4 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63824-713 | CEPACOL EXTRA STRENGTH SORE THROAT CHERRY (BENZOCAINE AND MENTHOL) LOZENGE [RB HEALTH (US) LLC] | 10 | Current NDC, Legacy NDC, 6 package rows | 20250330_941e36dd-d8d0-4e5c-8585-10e8f06bf8f0.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 |
|---|
| 63824-713-04 | 63824071304 | 1 BLISTER PACK in 1 CARTON (63824-713-04) > 4 LOZENGE in 1 BLISTER PACK | 1 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |
| 63824-713-16 | 63824071316 | 2 BLISTER PACK in 1 CARTON (63824-713-16) / 8 LOZENGE in 1 BLISTER PACK | 2 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |
| 63824-713-94 | 63824071394 | 1 BLISTER PACK in 1 CARTON (63824-713-94) > 4 LOZENGE in 1 BLISTER PACK | 1 blister pack | 2013-07-15 | 0000-00-00 | No | No | Current |