gumsol

Generic: benzocaine, zinc chloride

Labeler: kramer novis
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name gumsol
Generic Name benzocaine, zinc chloride
Labeler kramer novis
Dosage Form SPRAY
Routes
ORAL
Active Ingredients

benzocaine 1.5 g/30mL, zinc chloride .03 g/30mL

Manufacturer
Kramer Novis

Identifiers & Regulatory

Product NDC 52083-714
Product ID 52083-714_df716e50-f0a6-4548-b354-29dd8c29924c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2014-02-28

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 52083714
Hyphenated Format 52083-714

Supplemental Identifiers

RxCUI
485558
UNII
U3RSY48JW5 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 gumsol (source: ndc)
Generic Name benzocaine, zinc chloride (source: ndc)
Application Number M022 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 g/30mL
  • .03 g/30mL
source: ndc
Packaging
  • 30 mL in 1 BOTTLE (52083-714-01)
source: ndc

Packages (1)

52083-714-01 30 mL in 1 BOTTLE (52083-714-01)

Ingredients (2)

benzocaine (1.5 g/30mL) zinc chloride (.03 g/30mL)

Linked Drug Pages (1)

Gumsol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df716e50-f0a6-4548-b354-29dd8c29924c", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728"], "unii": ["U3RSY48JW5", "86Q357L16B"], "rxcui": ["485558"], "spl_set_id": ["3bb651d9-d1c4-4c25-bcfc-cd13e2f0d3bf"], "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": ["Kramer Novis"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (52083-714-01)", "package_ndc": "52083-714-01", "marketing_start_date": "20140228"}], "brand_name": "Gumsol", "product_id": "52083-714_df716e50-f0a6-4548-b354-29dd8c29924c", "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": "52083-714", "generic_name": "Benzocaine, Zinc Chloride", "labeler_name": "Kramer Novis", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Gumsol", "active_ingredients": [{"name": "BENZOCAINE", "strength": "1.5 g/30mL"}, {"name": "ZINC CHLORIDE", "strength": ".03 g/30mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140228", "listing_expiration_date": "20261231"}