giltuss bucalsep

Generic: benzocaine, menthol, zinc chloride

Labeler: gil pharmaceutical corp
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name giltuss bucalsep
Generic Name benzocaine, menthol, zinc chloride
Labeler gil pharmaceutical corp
Dosage Form SPRAY
Routes
ORAL TOPICAL
Active Ingredients

benzocaine 6.5 g/100mL, menthol .1 g/100mL, zinc chloride .12 g/100mL

Manufacturer
Gil Pharmaceutical Corp

Identifiers & Regulatory

Product NDC 58552-135
Product ID 58552-135_40b86bd0-283d-5043-e063-6394a90ada9c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2018-07-26

Pharmacologic Class

Established (EPC)
standardized chemical allergen [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58552135
Hyphenated Format 58552-135

Supplemental Identifiers

RxCUI
2170427
UNII
U3RSY48JW5 L7T10EIP3A 86Q357L16B
NUI
N0000185508 N0000175629 N0000184306 M0000728

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name giltuss bucalsep (source: ndc)
Generic Name benzocaine, menthol, zinc chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL TOPICAL
source: ndc

Resolved Composition

Strengths
  • 6.5 g/100mL
  • .1 g/100mL
  • .12 g/100mL
source: ndc
Packaging
  • 1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY
source: ndc

Packages (1)

58552-135-01 1 BOTTLE, SPRAY in 1 CARTON (58552-135-01) / 30 mL in 1 BOTTLE, SPRAY

Ingredients (3)

benzocaine (6.5 g/100mL) menthol (.1 g/100mL) zinc chloride (.12 g/100mL)

Linked Drug Pages (1)

Giltuss Bucalsep ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "TOPICAL"], "spl_id": "40b86bd0-283d-5043-e063-6394a90ada9c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "L7T10EIP3A", "86Q357L16B"], "rxcui": ["2170427"], "spl_set_id": ["85053391-8d71-ab4f-e053-2991aa0a7e08"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, SPRAY in 1 CARTON (58552-135-01)  / 30 mL in 1 BOTTLE, SPRAY", "package_ndc": "58552-135-01", "marketing_start_date": "20180726"}], "brand_name": "Giltuss Bucalsep", "product_id": "58552-135_40b86bd0-283d-5043-e063-6394a90ada9c", "dosage_form": "SPRAY", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Copper Absorption Inhibitor [EPC]", "Decreased Copper Ion Absorption [PE]", "Increased Histamine Release [PE]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "58552-135", "generic_name": "Benzocaine, Menthol, Zinc chloride", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Bucalsep", "active_ingredients": [{"name": "BENZOCAINE", "strength": "6.5 g/100mL"}, {"name": "MENTHOL", "strength": ".1 g/100mL"}, {"name": "ZINC CHLORIDE", "strength": ".12 g/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180726", "listing_expiration_date": "20261231"}