Home NDC 76420-145 Zylotrol
Product NDC 76420-145
11-digit product format 764200145
Labeler code 76420
Product ID 76420-145_07cebfba-4f3b-882f-e063-6294a90ac460
Type HUMAN OTC DRUG
Nonproprietary name Lidocaine HCl 4%, Menthol 1%
Dosage form GEL
Route TOPICAL
Labeler Asclemed USA, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-12
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 4; 1 g/100g; g/100g
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 Zylotrol
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 4 g/100g MENTHOL, UNSPECIFIED FORM 1 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V13007Z41A Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1373137 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 76420-145-04 Zylotrol 1 in 1 BOX GEL 1 3 76420-145-04 Zylotrol 118.3 g in 1 TUBE GEL 118.3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76420-145 ZYLOTROL (LIDOCAINE HCL 4%, MENTHOL 1%) GEL [ASCLEMED USA, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20231016_e13984ea-73a9-2894-e053-2995a90a8ed6.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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 76420-145-04 76420014504 1 TUBE in 1 BOX (76420-145-04) / 118.3 g in 1 TUBE 1 tube 2022-06-12 0000-00-00 No No Current