Home NDC 58593-783 Finafta
Product NDC 58593-783
11-digit product format 585930783
Labeler code 58593
Product ID 58593-783_411e9f10-dd14-5800-e063-6294a90afb4b
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine, Glycerin
Dosage form LIQUID
Route TOPICAL
Labeler Efficient Laboratories Inc.
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-09-15
Substance BENZOCAINE; GLYCERIN
Active strength 5; 33 mg/100mL; mg/100mL
Pharmacologic classes 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]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Finafta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 5 mg/100mL GLYCERIN 33 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup PDC6A3C0OX Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58593-783-15 Finafta 15 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 15 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58593-783 FINAFTA (BENZOCAINE, GLYCERIN) LIQUID [EFFICIENT LABORATORIES INC.] 6 Current NDC, 1 package rows 20241016_03368603-3e11-c2fa-e063-6294a90a04ea.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 29 of 40 · 786 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58593-783-15 58593078315 15 mL in 1 BOTTLE, WITH APPLICATOR (58593-783-15) 15 ml 2023-09-15 No No Current