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 135 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Capsaicin	CAPSAICIN	Rugby Laboratories	c5915c84-84a2-46f6-9f97-0d9873e9944a	2024-02-12	Warnings	Exact identifier application number: M017
Leader Ice Blue Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	952e56ea-5cbc-4078-bd01-5d3b6864a5ce	2024-02-09	Warnings	Exact identifier application number: M017
Leader Ultra Strength Muscle Rub Topical Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Cardinal Health, 110 dba LEADER	9d99a900-60e0-454c-98e0-2c63eb910cf1	2024-02-09	Warnings	Exact identifier application number: M017
Pain Relieving	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	28821ffa-a138-47b5-8857-beadf7a20d43	2024-02-08	Warnings	Exact identifier application number: M017
Menthol Camphor Cough Suppressant Topical Analgesic Rub	CAMPHOR (NATURAL) AND MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	fd0ea70a-ef12-48b1-8d9d-cc5f6417f854	2024-02-08	Warnings	Exact identifier application number: M017
Pain Relieving Cooling	MENTHOL, UNSPECIFIED FORM	J.R. Watkins, LLC.	3574d48a-b546-4ea7-b470-071bb328de64	2024-02-08	Warnings	Exact identifier application number: M017
Advil Targeted Relief	CAMPHOR, CAPSAICIN, MENTHOL, METHYL SALICYLATE	Haleon US Holdings LLC	16e6be21-7b43-443a-89ec-3bdf0ec0dfc1	2024-02-08	Warnings	Exact identifier application number: M017
POINT RELIEF COLD SPOT Pain Relieving	MENTHOL	FABRICATION ENTERPRISES	96f1d592-6cec-412e-a5fd-cf3c4f68644f	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	1c5eb3b3-79b3-472a-ae36-ec6a7dc72925	2024-02-07	Warnings	Exact identifier application number: M017
Lidocaine Hydrochloride	LIDOCAINE HYDROCHLORIDE	Safetec of America, Inc.	8eb3e7e2-26e5-430e-89aa-40a0367c637e	2024-02-07	Warnings	Exact identifier application number: M017
Nova Natura Topical Analgesic	CAMPHOR, CAPSICUM OLEORESIN, METHYL SALICYLATE	SEYITLER KIMYA SANAYI ANONIM SIRKETI	abf00f73-f0b1-439e-85aa-bbce8a1ec920	2024-02-06	Warnings	Exact identifier application number: M017
Leader Burn Relief	LIDOCAINE	Cardinal Health	f4e8e3b7-fd84-bdbc-e053-2a95a90aeab2	2024-02-06	Warnings	Exact identifier application number: M017
Pain Relieving Petro Carbo	PHENOL	J.R. Watkins, LLC.	050cf17d-3be7-45b9-8524-ad82af309a0e	2024-02-06	Warnings	Exact identifier application number: M017
White Cream	CAMPHOR (NATURAL) AND TURPENTINE OIL	J.R. Watkins, LLC.	e4de0734-59d5-478c-86ea-66fc2ba003e7	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving Roll-On	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	80118260-9c88-402d-9a90-ecfe62b4b54f	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL, UNSPECIFIED FORM	Safetec of America, Inc.	df512ce6-ce1b-434d-9571-fb2e1d76e1d0	2024-02-05	Warnings	Exact identifier application number: M017
Pain Relieving	MENTHOL	Safetec of America, Inc.	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2024-02-05	Warnings	Exact identifier application number: M017
Itch Relief	DIPHENHYDRAMINE HYDROCHLORIDE	Safetec of America, Inc.	4f4c801b-d894-4fa3-b024-6ca41a5f2a95	2024-02-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	79e3b0e7-4ba5-4b9d-a980-5b6f18dba802	2024-02-04	Warnings	Exact identifier application number: M017
HAV EZ Penetrating Pain Relief	MENTHOL	PALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC	70006efc-9cc8-4490-b28c-fcb23b1737c4	2024-02-01	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