Home NDC 54273-007 ZIMS MAX FREEZE
Product NDC 54273-007
11-digit product format 542730007
Labeler code 54273
Product ID 54273-007_3674680c-30ec-49e4-99b2-9319199ff6a5
Type HUMAN OTC DRUG
Nonproprietary name MENTHOL, UNSPECIFIED FORM
Dosage form GEL
Route TOPICAL
Labeler KOBAYASHI Healthcare International, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-01
Substance MENTHOL, UNSPECIFIED FORM
Active strength 70 mg/g
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
Brand name suffix PRO FORMULA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL, UNSPECIFIED FORM 70 mg/g
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 311509 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 54273-007-01 ZIMS MAX FREEZE PRO FORMULA 85 g in 1 BOTTLE, WITH APPLICATOR GEL 85 8 54273-007-02 ZIMS MAX FREEZE PRO FORMULA 102 g in 1 BOTTLE, WITH APPLICATOR GEL 102 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54273-007 ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231117_436e8578-b609-4b45-8f84-0d111140fda6.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 133 of 151 · 3,020 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. 1dc21c95-b419-4175-85f8-040b73060d37 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Roll-On Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. d94ae654-ce25-4bff-b9bd-24a0e0e8568a 2024-03-20 Warnings Exact identifier application number: M017 Pain Relief Muscle CAMPHOR (NATURAL) J.R. Watkins, LLC. f8bff018-fb4f-47b4-b8f8-4a496aede346 2024-03-20 Warnings Exact identifier application number: M017 Rugby Arthritis Pain Relieving Topical Analgesic CAPSAICIN Rugby Laboratories 8f1bc075-97ac-4154-8768-0d878104c3ba 2024-03-14 Warnings Exact identifier application number: M017 Rugby Ice Blue External Analgesic MENTHOL, UNSPECIFIED FORM Rugby Laboratories 2b65cb6a-4364-4770-b7b9-5c4637edd01a 2024-03-14 Warnings Exact identifier application number: M017 Leader Cooling Pain Relief Topical Analgesic MENTHOL, UNSPECIFIED FORM Cardinal Health, 110 dba LEADER fd06d17f-4dff-42a9-a84f-904809ceb981 2024-03-13 Warnings Exact identifier application number: M017 MENTHOL, CAMPHOR MENTHOL, CAMPHOR EROS GLOBAL b3495c95-ba4b-9459-e053-2a95a90a710f 2024-03-12 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 1369e70f-7a61-7078-e063-6394a90a9a88 2024-03-11 Warnings Exact identifier application number: M017 Pain Reliever Cream MENTHOL 10%, METHYL SALICYLATE 15% Trifecta Pharmaceuticals USA, LLC. 130665d6-3de8-cb91-e063-6294a90a2083 2024-03-06 Warnings Exact identifier application number: M017 Dermachange Aid Anti-Itch DIPHENHYDRAMINE HCL Private Label Beauty and Wellness 12ed906c-d028-0ff7-e063-6394a90aaa52 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Cold Therapy MENTHOL Private Label Beauty and Wellness 12ef7dd8-3da3-9c87-e063-6394a90ac924 2024-03-05 Warnings Exact identifier application number: M017 Dermachange Arthritis Relief TROLAMIN SALICYLATE Private Beauty Label and Wellness 12dbfa50-1b97-f988-e063-6394a90a662c 2024-03-04 Warnings Exact identifier application number: M017 Analgesic MENTHOL Safetec of America, Inc. b0f4010c-995f-40e1-aa40-92760e697a61 2024-03-02 Warnings Exact identifier application number: M017 Icy Hot Advanced Relief CAMPHOR AND MENTHOL Chattem, Inc. 9979ff36-415b-44e4-bb10-6bf682cd00f9 2024-03-01 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC 5051b650-18a4-481e-a8d7-d41d4ae51efd 2024-02-29 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE TRIFECTA PHARMACEUTICALS USA LLC 2999fecb-cb15-4023-ade4-ab5822b094d5 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8 MENTHOL Amish Origins Management, LLC aaad56d5-6737-4edc-af0e-8e207695c0ec 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Pain Relieving Menthol 8% MENTHOL Amish Origins Management, LLC b120404f-5a07-4182-bb50-d943418622da 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC 437491ca-60ff-4508-b408-f97e7152f638 2024-02-29 Warnings Exact identifier application number: M017 Amish Origins Topical Analgesic Camphor 2% CAMPHOR (SYNTHETIC) Amish Origins Management, LLC ffe15aed-ea90-4db8-aace-d691a81c05ae 2024-02-29 Warnings Exact identifier application number: M017
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 54273-007-01 54273000701 85 g in 1 BOTTLE, WITH APPLICATOR (54273-007-01) 85 g 2018-08-01 0000-00-00 No No Current 54273-007-02 54273000702 102 g in 1 BOTTLE, WITH APPLICATOR (54273-007-02) 102 g 2019-02-01 0000-00-00 No No Current