Home NDC 42829-550 Zilactin-B
Product NDC 42829-550
11-digit product format 428290550
Labeler code 42829
Product ID 42829-550_42eec176-84ad-1e81-e063-6394a90afd01
Type HUMAN OTC DRUG
Nonproprietary name benzocaine
Dosage form GEL
Route TOPICAL
Labeler ASCENT CONSUMER PRODUCTS, INC
Application M022
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-11-06
Substance BENZOCAINE
Active strength .1 g/g
Pharmacologic classes Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Zilactin-B
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BENZOCAINE .1 g/g
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198488 Internal RxNorm lookup 1542803 Internal RxNorm 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 42829-550-32 Zilactin-B 7 g in 1 TUBE GEL 7 1 42829-550-32 Zilactin-B 1 in 1 CARTON GEL 1 1
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 42829-550-32 42829055032 1 TUBE in 1 CARTON (42829-550-32) / 7 g in 1 TUBE 1 tube 2025-11-06 No No Current