Home NDC 54273-012 ZIMS MAX FREEZE
Product NDC 54273-012
11-digit product format 542730012
Labeler code 54273
Product ID 54273-012_d2b1f3a9-2b7b-4462-afd0-1a19e72981da
Type HUMAN OTC DRUG
Nonproprietary name LIDOCAINE HYDROCHLORIDE and MENTHOL,
Dosage form PATCH
Route TOPICAL
Labeler KOBAYASHI Healthcare International, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-10
Substance LIDOCAINE HYDROCHLORIDE; MENTHOL, UNSPECIFIED FORM
Active strength 760; 190 mg/1; mg/1
Pharmacologic classes Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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 ZIMS MAX FREEZE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LIDOCAINE HYDROCHLORIDE 760 mg/1 MENTHOL, UNSPECIFIED FORM 190 mg/1
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 1373130 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 54273-012-01 ZIMS MAX FREEZE 3 in 1 BOX PATCH 3 4 54273-012-01 ZIMS MAX FREEZE 1 in 1 POUCH PATCH 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54273-012 ZIMS MAX FREEZE (LIDOCAINE HYDROCHLORIDE AND MENTHOL,) PATCH [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 3 Current NDC, 2 package rows 20231117_e364ff83-4aaf-4897-a7da-06581bc321f2.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 Sample Exclude flag Status 54273-012-01 54273001201 3 POUCH in 1 BOX (54273-012-01) / 1 PATCH in 1 POUCH 3 pouch 2023-05-10 No No Current