ZIMS MAX FREEZE

Product NDC: 54273-006
11-digit product format: 542730006
Labeler code: 54273
Product ID: 54273-006_85731b59-73da-4aae-adf7-40cff79c4fb3
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: 2018-07-01
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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b44beac3-1d20-434f-9a79-4fab1ac68791	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54273-006-01	ZIMS MAX FREEZE PRO FORMULA	113 g in 1 TUBE	GEL	113	7
54273-006-02	ZIMS MAX FREEZE PRO FORMULA	136 g in 1 TUBE	GEL	136	7
54273-006-03	ZIMS MAX FREEZE PRO FORMULA	5 g in 1 PACKET	GEL	5	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54273-006	ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]	7	Current NDC, Legacy NDC, 3 package rows	20231116_b44beac3-1d20-434f-9a79-4fab1ac68791.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 123 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	H E B	34c7bcd3-203f-4630-894d-3739a1576c8d	2024-10-13	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	25ec9014-64c4-44df-9e67-9f9223ffc923	2024-10-12	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	LIDOCAINE AND MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f02fa9c0-b8af-f362-e053-2a95a90ae516	2024-10-11	Warnings	Exact identifier application number: M017
Insect Sting Relief Pad	BENZOCAINE, ALCOHOL	Hubei Changjian Medical Products Co., Ltd.	6a269982-0e25-4c09-aef1-0b398bdc5ed4	2024-10-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	24221805-e5c9-5785-e063-6394a90a9d2f	2024-10-10	Warnings	Exact identifier application number: M017
De La Cruz Camphor	CAMPHOR	DLC Laboratories, Inc.	62359237-de2d-4497-bfd6-36991cfc8acf	2024-10-10	Warnings	Exact identifier application number: M017
Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Meijer Distribution Inc	4f536a86-6419-4ab0-a7e8-5c37943823e2	2024-10-09	Warnings	Exact identifier application number: M017
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma, PT	da338796-de9c-be51-e053-2a95a90a2509	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated	MENTHOL METHYL SALICYLATE	Eagle Indo Pharma	e2c5f821-cdd5-190d-e053-2a95a90a9159	2024-10-07	Warnings	Exact identifier application number: M017
NanoXtreme Pain Relieving	MENTHOL, METHYL SALICYLATE	MG Science Technologies LLC	c1490c30-a9db-4120-adaf-9e8000169e46	2024-10-07	Warnings	Exact identifier application number: M017
CAREALL Hydrocortisone Maximum Strength	HYDROCORTISONE	New World Imports, Inc	ea656cf8-cad5-4fa5-82e7-daec77a0bb04	2024-10-07	Warnings	Exact identifier application number: M017
Eagle Medicated Oil Refreshing	MENTHOL, METHYL SALICYLATE	Eagle Indo Pharma, PT	e2729023-d689-7ae2-e053-2a95a90a78dc	2024-10-06	Warnings	Exact identifier application number: M017
Flanax Back Pain Relief	LIDOCAINE	Belmora LLC	46d33346-e582-4af1-b81a-feca7033dceb	2024-10-04	Warnings	Exact identifier application number: M017
Muscle Balm	MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)	Natural Essentials, Inc.	16918ba3-2e07-4232-9ed3-4c7751796cd2	2024-10-04	Warnings	Exact identifier application number: M017
Fast Freeze Pain Relieving Continuous	MENTHOL, UNSPECIFIED FORM	Natural Essentials, Inc.	998a4824-9ed9-4fe0-b45b-72e52861fcd3	2024-10-04	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311509	menthol 7 % Topical Gel	PSN	b44beac3-1d20-434f-9a79-4fab1ac68791	7
311509	menthol 0.07 MG/MG Topical Gel	SCD	b44beac3-1d20-434f-9a79-4fab1ac68791	7
311509	menthol 7 % Topical Gel	SY	b44beac3-1d20-434f-9a79-4fab1ac68791	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54273-006-01	54273000601	113 g in 1 TUBE (54273-006-01)	113 g	2018-07-01	0000-00-00	No	No	Current
54273-006-02	54273000602	136 g in 1 TUBE (54273-006-02)	136 g	2019-02-01	0000-00-00	No	No	Current
54273-006-03	54273000603	5 g in 1 PACKET (54273-006-03)	5 g	2019-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ZIM'S™ MAX FREEZE PRO FORMULA	KOBAYASHI Healthcare International, Inc. \| KOBAYASHI America Manufacturing, LLC	2023-11-15	HUMAN OTC DRUG LABEL	7