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NDC 58552-0135-01 Giltuss Bucalsep 6.5; .1; .12 g/100mL; g/100mL; g/100mL Details
Giltuss Bucalsep 6.5; .1; .12 g/100mL; g/100mL; g/100mL
Giltuss Bucalsep is a ORAL; TOPICAL SPRAY in the HUMAN OTC DRUG category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is BENZOCAINE; MENTHOL; ZINC CHLORIDE.
Product Information
| NDC | 58552-0135 |
|---|---|
| Product ID | 58552-135_08741352-8ee7-1603-e063-6394a90a93a1 |
| Associated GPIs | 88359903230920 |
| GCN Sequence Number | 080924 |
| GCN Sequence Number Description | benzocaine/menthol/zinc chlor SPRAY 6.5 %-0.1% MUCOUS MEM |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 47912 |
| HICL Sequence Number | 046243 |
| HICL Sequence Number Description | BENZOCAINE/MENTHOL/ZINC CHLORIDE |
| Brand/Generic | Brand |
| Proprietary Name | Giltuss Bucalsep |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Benzocaine, Menthol, Zinc chloride |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SPRAY |
| Route | ORAL; TOPICAL |
| Active Ingredient Strength | 6.5; .1; .12 |
| Active Ingredient Units | g/100mL; g/100mL; g/100mL |
| Substance Name | BENZOCAINE; MENTHOL; ZINC CHLORIDE |
| Labeler Name | Gil Pharmaceutical Corp |
| Pharmaceutical Class | Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC] |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH DRUG |
| Application Number | M022 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 58552-0135-01 (58552013501)
| NDC Package Code | 58552-135-01 |
|---|---|
| Billing NDC | 58552013501 |
| Package | 1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY |
| Marketing Start Date | 2018-07-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |