Home NDC 0121-1077 Benzocaine 20%
Product NDC 0121-1077
11-digit product format 001211077
Labeler code 0121
Product ID 0121-1077_83139f6d-1d4d-47d5-8da5-5dad5b9fe3b7
Type HUMAN OTC DRUG
Nonproprietary name Benzocaine 20%
Dosage form SOLUTION
Route TOPICAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-03-20
Substance BENZOCAINE
Active strength 200 mg/mL
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], 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 Benzocaine 20%
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination U3RSY48JW5 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308657 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1077-01 Benzocaine 20% 1 in 1 POUCH SOLUTION 1 4 0121-1077-01 Benzocaine 20% 0.5 mL in 1 APPLICATOR SOLUTION 0.5 4 0121-1077-25 Benzocaine 20% 25 in 1 CARTON SOLUTION 25 4
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 9 of 40 · 786 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0121-1077-01 00121107701 1 in 1 POUCH Historical 0121-1077-25 00121107725 25 POUCH in 1 CARTON (0121-1077-25) / 1 APPLICATOR in 1 POUCH (0121-1077-01) / .5 mL in 1 APPLICATOR 25 pouch 2026-03-20 No No Current