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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
436e8578-b609-4b45-8f84-0d111140fda6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

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 138 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MED O-3 BIO-	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Biological M.D. Solutions LLC	02707552-03d9-3ad2-e063-6294a90a3472	2024-01-06	Warnings	Exact identifier application number: M017
Sumifun Knee Relieving Patch	KNEE RELIEVING PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e7e73ec-ab33-9235-e063-6394a90ad950	2024-01-06	Warnings	Exact identifier application number: M017
Lidocaine Numbing Cream	LIDOCAINE	YYBA Corp	de6dc194-c6ef-4cb5-be3f-e772ace9abaf	2024-01-03	Warnings	Exact identifier application number: M017
Equate Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Walmart Inc.	0cdc9323-f5c3-468c-a7ae-83dfd2d76626	2024-01-03	Warnings	Exact identifier application number: M017
OWELL NATURALS Deep Penetrating Pain Relief	MENTHOL	OWELL NATURALS BRAND, LLC	b36eb017-ed8d-476e-994b-22b275e00543	2024-01-02	Warnings	Exact identifier application number: M017
Dibucaine	DIBUCAINE 1%	Trifecta Pharmaceuticals USA LLC	e8a56651-a292-7609-e053-2a95a90a7c36	2024-01-02	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Trifecta Pharmaceuticals USA, LLC.	44d17651-a31b-64ca-e054-00144ff8d46c	2024-01-02	Warnings	Exact identifier application number: M017
Muscle Rub Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	e0a13344-5493-eb51-e053-2995a90a8183	2024-01-02	Warnings	Exact identifier application number: M017
Sumifun Knee Relieve Patch	KNEE RELIEVE PATCH	Zhengzhou Miaoqi Pharmaceutical Technology Co., Ltd	0e031aa5-edf4-8c9d-e063-6394a90afee3	2024-01-02	Warnings	Exact identifier application number: M017
OKeeffes Healthy Feet	ALLANTOIN, LIDOCAINE	The Gorilla Glue Company/O'Keeffe's Company	d73709db-3932-3c56-e053-2995a90a7d0a	2024-01-01	Warnings	Exact identifier application number: M017
PERSONAL CARE ICE COLD	MENTHOL	NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.	1994356c-e347-5b7d-e063-6394a90a476c	2024-01-01	Warnings	Exact identifier application number: M017
Dendracin Neurodendraxcin	METHYL SALICYLATE, MENTHOL AND CAPSAICIN	Proficient Rx LP	7e765fc1-74c6-4af3-a9cf-05b57011d7d8	2024-01-01	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Itch Relief Moisturizing	PRAMOXINE HYDROCHLORIDE	L'Oreal USA Products Inc	c6a0880e-fc16-46e9-8314-c56c9d15bf31	2023-12-31	Warnings	Exact identifier application number: M017
CeraVe Developed with Dermatologists Anti Itch	HYDROCORTISONE	L'Oreal USA Products Inc.	8d65e945-2557-486f-9279-ecbaa08f31c4	2023-12-31	Warnings	Exact identifier application number: M017
Nighttime Sleep-Aid Non-Habit Forming	DIPHENHYDRAMINE HCI	AptaPharma Inc.	ed0ba7aa-e794-43da-b576-6b9945bf7477	2023-12-30	Warnings	Exact identifier application number: M017
Sting-Kill	BENZOCAINE AND MENTHOL	RANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH	b8bd9280-f20a-4b2a-aef7-a0ba7b3b8701	2023-12-29	Warnings	Exact identifier application number: M017
Maybelline New York Baby Lips Dr Rescue Medicated Balm	MENTHOL	L'Oreal USA Products Inc	2f7b8221-66f6-4aed-8359-318cfc656a72	2023-12-28	Warnings	Exact identifier application number: M017
Equate Cortisone	HYDROCORTISONE 1%	Walmart Inc	027fae33-93a0-a61f-e063-6294a90a990f	2023-12-27	Warnings	Exact identifier application number: M017
Walgreens Cool n Heat Lidocaine	LIDOCAINE HCL 4%	Walgreens Co	0681c6c5-5a8b-ea9e-e063-6394a90a83bc	2023-12-27	Warnings	Exact identifier application number: M017
EXTRA STRENGTH WAL-DRYL ITCH RELIEF	DIPHENHYDRAMINE, ZINC ACETATE	WALGREEN CO	681cf1af-2cc3-4e6d-b76f-f00731ea3e12	2023-12-27	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	436e8578-b609-4b45-8f84-0d111140fda6	8
311509	menthol 0.07 MG/MG Topical Gel	SCD	436e8578-b609-4b45-8f84-0d111140fda6	8
311509	menthol 7 % Topical Gel	SY	436e8578-b609-4b45-8f84-0d111140fda6	8

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

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	2023-11-16	HUMAN OTC DRUG LABEL	8