Cepacol
- Product NDC
- 63824-744
- 11-digit product format
- 638240744
- Labeler code
- 63824
- Product ID
- 63824-744_51b5d087-def6-54b3-e063-6294a90ac9ad
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- BENZOCAINE and DEXTROMETHORPHAN HYDROBROMIDE
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Reckitt Benckiser LLC
- Application
- M012
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-05-05
- Substance
- BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE
- Active strength
- 7.5; 5 mg/1; mg/1
- Pharmacologic classes
- 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 Receptor Antagonists [MoA]
- 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 and Cough
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 7.5 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5, 9D2RTI9KYH |
| Rxcui | 1039251, 1039255 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63824-744-16 | CepacolExtra Strength Sore Throat and Cough | 8 in 1 BLISTER PACK | LOZENGE | 8 | | 14 |
| 63824-744-16 | CepacolExtra Strength Sore Throat and Cough | 2 in 1 CARTON | LOZENGE | 2 | | 14 |
| 63824-744-36 | CepacolExtra Strength Sore Throat and Cough | 3 in 1 CARTON | LOZENGE | 3 | | 14 |
| 63824-744-36 | CepacolExtra Strength Sore Throat and Cough | 12 in 1 BLISTER PACK | LOZENGE | 12 | | 14 |
| 63824-744-94 | CepacolExtra Strength Sore Throat and Cough | 4 in 1 BLISTER PACK | LOZENGE | 4 | | 14 |
| 63824-744-94 | CepacolExtra Strength Sore Throat and Cough | 1 in 1 CARTON | LOZENGE | 1 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63824-744 | CEPACOL EXTRA STRENGTH SORE THROAT AND COUGH (BENZOCAINE AND DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC] | 10 | Current NDC, Legacy NDC, 6 package rows | 20250323_c0cc32db-90f0-4106-8538-89821083ece1.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 |
|---|
| 63824-744-16 | 63824074416 | 2 BLISTER PACK in 1 CARTON (63824-744-16) / 8 LOZENGE in 1 BLISTER PACK | 2 blister pack | 2014-05-05 | 0000-00-00 | No | No | Current |
| 63824-744-36 | 63824074436 | 3 BLISTER PACK in 1 CARTON (63824-744-36) > 12 LOZENGE in 1 BLISTER PACK | 3 blister pack | 2019-05-01 | 0000-00-00 | No | No | Current |
| 63824-744-94 | 63824074494 | 1 BLISTER PACK in 1 CARTON (63824-744-94) > 4 LOZENGE in 1 BLISTER PACK | 1 blister pack | 2014-05-05 | 0000-00-00 | No | No | Current |