Giltuss Bucalsep
- Product NDC
- 65852-015
- 11-digit product format
- 658520015
- Labeler code
- 65852
- Product ID
- 65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Benzocaine, Menthol, Zinc chloride
- Dosage form
- SPRAY
- Route
- ORAL; TOPICAL
- Labeler
- Dextrum Laboratories Inc.
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-07-26
- Substance
- BENZOCAINE; MENTHOL; ZINC CATION
- Active strength
- 6.5; .1; .12 mg/100mL; mg/100mL; mg/100mL
- Pharmacologic classes
- Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Giltuss Bucalsep
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENZOCAINE | 6.5 mg/100mL |
| MENTHOL | .1 mg/100mL |
| ZINC CATION | .12 mg/100mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | U3RSY48JW5, L7T10EIP3A, 13S1S8SF37 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65852-015-01 | Giltuss Bucalsep | 1 in 1 CARTON | SPRAY | 1 | | 1 |
| 65852-015-01 | Giltuss Bucalsep | 30 mL in 1 BOTTLE, PLASTIC | SPRAY | 30 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 65852-015-01 | 65852001501 | 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC | 2018-07-26 | No | No | Current |