Home NDC 54273-009-01 ZIMS MAX FREEZE
Product NDC 54273-009
Requested package NDC 54273-009-01
11-digit product format 542730009
Labeler code 54273
Product ID 54273-009_171be518-73bb-4425-9565-1545166d3f51
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form LIQUID
Route TOPICAL
Labeler KOBAYASHI Healthcare International, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-20
Substance MENTHOL, UNSPECIFIED FORM
Active strength 160 mg/mL
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 ZIMS MAX FREEZE
Brand name suffix PRO FORMULA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 160 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 866084 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 54273-009-01 ZIMS MAX FREEZE PRO FORMULA 89 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 89 9 54273-009-01 ZIMS MAX FREEZE PRO FORMULA 1 in 1 CARTON LIQUID 1 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54273-009 ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) LIQUID [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 9 Current NDC, Legacy NDC, 2 package rows 20231117_4d91baf3-9655-4786-93b8-aa0d93fe0bf9.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 Marketing start Marketing end Sample Exclude flag Status 54273-009-01 54273000901 1 BOTTLE, WITH APPLICATOR in 1 CARTON (54273-009-01) / 89 mL in 1 BOTTLE, WITH APPLICATOR 2018-08-20 0000-00-00 No No Current