FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL, UNSPECIFIED FORM70 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311509Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
436e8578-b609-4b45-8f84-0d111140fda6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-007-01ZIMS MAX FREEZE PRO FORMULA85 g in 1 BOTTLE, WITH APPLICATORGEL858
54273-007-02ZIMS MAX FREEZE PRO FORMULA102 g in 1 BOTTLE, WITH APPLICATORGEL1028

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-007ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]8Current NDC, Legacy NDC, 2 package rows20231117_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 15 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine and MentholLIDOCAINE AND MENTHOLAdvanced Rx of Tennessee, LLC44840250-2112-6ef4-e063-6394a90acdcc2026-06-12WarningsExact identifier
application number: M017
DRAWYUM Pain Relief Gel-PatchLIDOCAINE 4% PAIN RELIEF GEL-PATCHJiangxi Yudexi Pharmaceutical Co., LTD497e6e18-ba46-0001-e063-6294a90af0262026-06-12WarningsExact identifier
application number: M017
NATUHEAL JOINT BACK PAIN RELIEFARNICA MONTANA HPUS 7% JOINT BACK PAIN RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4c923afa-4d1e-0776-e063-6294a90a2f542026-06-12WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Aldermed Inc.4a7b532e-b292-b595-e063-6394a90acc9c2026-06-12WarningsExact identifier
application number: M017
MG PLUS MENTHOLMENTHOLRENU LABORATORIES, LLC53737365-b985-3800-e063-6294a90a37f22026-06-11WarningsExact identifier
application number: M017
CeraVe Developed with Dermatologists Itch Relief MoisturizingPRAMOXINE HYDROCHLORIDEL'Oreal USA Products Inc7c78d980-fc94-498c-aec5-464c0c76c8f42026-06-11WarningsExact identifier
application number: M017
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4a47f1ed-d8cf-3b0b-e063-6394a90a932a2026-06-11WarningsExact identifier
application number: M017
Anti-Itch Soothing Wipes 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC81ab7fa7-d9b0-49dc-9782-02f37e588c5e2026-06-10WarningsExact identifier
application number: M017
HealthWise Pain Relief Cream with LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcareef176d33-10b9-ddb2-e053-2995a90a76e32026-06-10WarningsExact identifier
application number: M017
Warm Patch Tong Gu Huo Luo GaoPAIN PATCHSheng Chang Pharmaceutical Co, Ltd. Zhongli Factory6906c4a0-1557-45e3-b915-80e4dd652ee72026-06-10WarningsExact identifier
application number: M017
LidoMedixLIDOCAINE, MENTHOL, CAMPHORAbsolute Therapeutics, LLC53d504ef-eea3-6a47-e063-6394a90a1f652026-06-09WarningsExact identifier
application number: M017
good sense anti itchHYDROCORTISONEPreferred Pharmaceuticals Inc.e51047da-8e17-4dd7-be3c-54820a7485f22026-06-09WarningsExact identifier
application number: M017
Terramed Just Think Comfort GynoCare BV Guard Intimate WashPRAMOXINE HYDROCHLORIDERida LLC09964550-049c-4c3b-817d-37e660c2e45c2026-06-08WarningsExact identifier
application number: M017
Quality Choice Lidocaine Pain Relief PatchLIDOCAINEQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)526abe69-4bbc-6e73-e063-6394a90ad25d2026-06-08WarningsExact identifier
application number: M017
Dcsily Numbing CreamLIDOCAINEShenzhen Xinxin Yunhai Technology Co., Ltd.53cab09c-6d5d-471e-e063-6294a90aa9772026-06-08WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin cream for sensitive skinCAPSAICIN 0.1%Easment LLC537e0106-9e1c-66b8-e063-6294a90ac5382026-06-05WarningsExact identifier
application number: M017
Maximum Strength Pain ReliefMENTHOL CREAMOWELL NATURALS LLC5388f2c5-8cfd-a601-e063-6294a90a2e5f2026-06-04WarningsExact identifier
application number: M017
MG PLUS ROLL ONMENTHOL ROLL ONRENU LABORATORIES, LLC535dc42f-38c7-2afc-e063-6294a90ae23d2026-06-03WarningsExact identifier
application number: M017
OP First Aid Series Insect Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.b43af183-834a-0f64-e053-2995a90a32182026-06-03WarningsExact identifier
application number: M017
PURE PRIMAL DELAYLIDOCAINE HCLProdigy Media Inc1ddab664-7c44-452f-854f-e386cd69505e2026-06-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311509menthol 7 % Topical GelPSN436e8578-b609-4b45-8f84-0d111140fda68
311509menthol 0.07 MG/MG Topical GelSCD436e8578-b609-4b45-8f84-0d111140fda68
311509menthol 7 % Topical GelSY436e8578-b609-4b45-8f84-0d111140fda68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54273-007-015427300070185 g in 1 BOTTLE, WITH APPLICATOR (54273-007-01) 85 g2018-08-010000-00-00NoNoCurrent
54273-007-0254273000702102 g in 1 BOTTLE, WITH APPLICATOR (54273-007-02) 102 g2019-02-010000-00-00NoNoCurrent