finafta

Generic: benzocaine, glycerin

Labeler: efficient laboratories inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name finafta
Generic Name benzocaine, glycerin
Labeler efficient laboratories inc.
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

benzocaine 5 mg/100mL, glycerin 33 mg/100mL

Manufacturer
Efficient Laboratories Inc.

Identifiers & Regulatory

Product NDC 58593-783
Product ID 58593-783_411e9f10-dd14-5800-e063-6294a90afb4b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M022
Listing Expiration 2026-12-31
Marketing Start 2023-09-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58593783
Hyphenated Format 58593-783

Supplemental Identifiers

UNII
U3RSY48JW5 PDC6A3C0OX
NUI
N0000185508 N0000175629 N0000184306 M0000728 N0000185370 N0000185001 M0009417

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 finafta (source: ndc)
Generic Name benzocaine, glycerin (source: ndc)
Application Number M022 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/100mL
  • 33 mg/100mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE, WITH APPLICATOR (58593-783-15)
source: ndc

Packages (1)

58593-783-15 15 mL in 1 BOTTLE, WITH APPLICATOR (58593-783-15)

Ingredients (2)

benzocaine (5 mg/100mL) glycerin (33 mg/100mL)

Linked Drug Pages (1)

Finafta ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "411e9f10-dd14-5800-e063-6294a90afb4b", "openfda": {"nui": ["N0000185508", "N0000175629", "N0000184306", "M0000728", "N0000185370", "N0000185001", "M0009417"], "unii": ["U3RSY48JW5", "PDC6A3C0OX"], "spl_set_id": ["03368603-3e11-c2fa-e063-6294a90a04ea"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Standardized Chemical Allergen [EPC]", "Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Efficient Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE, WITH APPLICATOR (58593-783-15)", "package_ndc": "58593-783-15", "marketing_start_date": "20230915"}], "brand_name": "Finafta", "product_id": "58593-783_411e9f10-dd14-5800-e063-6294a90afb4b", "dosage_form": "LIQUID", "pharm_class": ["Allergens [CS]", "Allergens [CS]", "Cell-mediated Immunity [PE]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]", "Standardized Chemical Allergen [EPC]"], "product_ndc": "58593-783", "generic_name": "Benzocaine, Glycerin", "labeler_name": "Efficient Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Finafta", "active_ingredients": [{"name": "BENZOCAINE", "strength": "5 mg/100mL"}, {"name": "GLYCERIN", "strength": "33 mg/100mL"}], "application_number": "M022", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230915", "listing_expiration_date": "20261231"}