giltuss bucalsep

Generic: benzocaine, menthol, zinc chloride

Labeler: dextrum laboratories inc.
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 dextrum laboratories inc.
Dosage Form SPRAY
Routes
ORAL TOPICAL
Active Ingredients

benzocaine 6.5 mg/100mL, menthol .1 mg/100mL, zinc cation .12 mg/100mL

Manufacturer
Dextrum Laboratories Inc.

Identifiers & Regulatory

Product NDC 65852-015
Product ID 65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd
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] copper absorption inhibitor [epc]
Chemical Structure
allergens [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] decreased copper ion absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65852015
Hyphenated Format 65852-015

Supplemental Identifiers

UNII
U3RSY48JW5 L7T10EIP3A 13S1S8SF37
NUI
N0000185508 N0000175629 N0000184306 M0000728 N0000175530 N0000175529

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 mg/100mL
  • .1 mg/100mL
  • .12 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

65852-015-01 1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01) / 30 mL in 1 BOTTLE, PLASTIC

Ingredients (3)

benzocaine (6.5 mg/100mL) menthol (.1 mg/100mL) zinc cation (.12 mg/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": "3fa233dc-156d-1e95-e063-6294a90a8bbd", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728", "N0000175530", "N0000175529"], "unii": ["U3RSY48JW5", "L7T10EIP3A", "13S1S8SF37"], "spl_set_id": ["3fa233dc-156c-1e95-e063-6294a90a8bbd"], "pharm_class_cs": ["Allergens [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Decreased Copper Ion Absorption [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]", "Copper Absorption Inhibitor [EPC]"], "manufacturer_name": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-015-01)  / 30 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-015-01", "marketing_start_date": "20180726"}], "brand_name": "Giltuss Bucalsep", "product_id": "65852-015_3fa233dc-156d-1e95-e063-6294a90a8bbd", "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": "65852-015", "generic_name": "Benzocaine, Menthol, Zinc chloride", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Bucalsep", "active_ingredients": [{"name": "BENZOCAINE", "strength": "6.5 mg/100mL"}, {"name": "MENTHOL", "strength": ".1 mg/100mL"}, {"name": "ZINC CATION", "strength": ".12 mg/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20180726", "listing_expiration_date": "20261231"}