CEPASTAT
- Product NDC
- 63736-205
- 11-digit product format
- 637360205
- Labeler code
- 63736
- Product ID
- 63736-205_1848b27b-f672-42fa-92dd-69f7a776ae63
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Dextromethorphan HBr, Menthol
- Dosage form
- LOZENGE
- Route
- ORAL
- Labeler
- Insight Pharmaceuticals LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-10-01
- Substance
- BENZOCAINE; DEXTROMETHORPHAN HYDROBROMIDE; MENTHOL
- Active strength
- 6; 5; 10 mg/1; 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CEPASTAT
- Brand name suffix
- Sore throat and Cough
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 6 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 5 mg/1 |
| MENTHOL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5, 9D2RTI9KYH, L7T10EIP3A |
| Rxcui | 1045532, 1872897 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63736-205-01 | CEPASTATSore throat and Cough | 6 in 1 BLISTER PACK | LOZENGE | 6 | | 3 |
| 63736-205-01 | CEPASTATSore throat and Cough | 3 in 1 CARTON | LOZENGE | 3 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63736-205 | CEPASTAT SORE THROAT AND COUGH (BENZOCAINE, DEXTROMETHORPHAN HBR, MENTHOL) LOZENGE [INSIGHT PHARMACEUTICALS LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241105_93f0e60f-4dda-4ec9-b391-e059a0876654.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 |
|---|
| 63736-205-01 | 63736020501 | 3 BLISTER PACK in 1 CARTON (63736-205-01) / 6 LOZENGE in 1 BLISTER PACK | 3 blister pack | 2016-10-01 | 0000-00-00 | No | No | Current |