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 146 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BODY ACTION PRODUCTS Climax Control GelBENZOCAINEPRODUCT MAX GROUP INC53e746cc-0078-4381-bf0b-9c8f98d669042023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Endless Love for MenBENZOCAINEPRODUCT MAX GROUP INCd0fa792d-dc04-4bdf-a22d-dea896beae5b2023-11-10WarningsExact identifier
application number: M017
Endless Love For MenBENZOCAINEBody Action Products, Inc4e89cd3a-ecad-44c3-acb3-6d0810add8c02023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Higher Control Male ClimaxBENZOCAINEPRODUCT MAX GROUP INC3c7fa73b-abe8-4a8d-951c-4e785d6e812c2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC65a319a6-89d2-44c9-81d5-30327f9948cb2023-11-10WarningsExact identifier
application number: M017
Uber NumbLIDOCAINE HYDROCHLORIDEUBERScientific, LLC768f3f0e-1add-404f-b869-00a9f35ad34a2023-11-10WarningsExact identifier
application number: M017
Zcaine Fast Acting AnestheticLIDOCAINEPHI, Incd072243f-6ba6-4ab6-8ebf-a2381fa9c2df2023-11-09WarningsExact identifier
application number: M017
Plum Smooth Plumb Numb GeleeLIDOCAINEUniversal Companies, Inc.6be7d8e0-6cd0-4da2-926f-3dbb3db3bd8e2023-11-09WarningsExact identifier
application number: M017
Sonacaine Topical Anesthetic With MentholLIDOCAINEFilltech USA, LLCca54c6da-4bf2-4e63-ba7f-a69c4f9c431a2023-11-09WarningsExact identifier
application number: M017
Bed Bug Instant Bite ReliefLIDOCAINEP.F. Harris Mfg. Co. LLC7f472fd0-5605-4cc6-b4b2-1267e815255c2023-11-09WarningsExact identifier
application number: M017
Valtrum Aerobic SportsSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC33f2491e-c1f2-4e5a-acbe-8ace844b88d62023-11-09WarningsExact identifier
application number: M017
Valtrum Topical Analgesic Roll OnSALICYLIC ACID MENTHOL CAMPHOR (NATURAL)LABORATORIOS QUANTIUM LLC28167e2a-9afb-44e7-90c7-9577df9504b62023-11-09WarningsExact identifier
application number: M017
Satohap Cool TypeCAMPHOR, MENTHOL, METHYL SALICYLATESato Pharmaceutical Co., Ltd.fe07a00a-2699-44d3-887d-bd068948ad7b2023-11-07WarningsExact identifier
application number: M017
Hims Delay WipesBENZOCAINE WIPESHims Inc.adbead3d-dca0-4919-b688-44c88f779e5a2023-11-07WarningsExact identifier
application number: M017
Bakers Best Maximum Strength Pain ReliefLIDOCAINE HYDROCHLORIDE, MENTHOLBaker's Best Health Products, LLC9d160ff1-9c23-4a5d-82b3-82c2e1e7d34d2023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Pain Relief with Pure Hemp Seed OilLIDOCAINE HYDROCHLORIDE, MENTHOLBAKER'S BEST HEALTH PRODUCTS, INC.ae54c234-bfe4-4a74-b293-db7efda7884b2023-11-06WarningsExact identifier
application number: M017
Arth RX Topical AnalgesicMETHYL NICOTINATE, CAPSAICINHCD Salesa7b3b9b4-b1c4-4e51-8e3a-c84f64c756092023-11-06WarningsExact identifier
application number: M017
BAKERS BEST Arthritis Pain Relief Cream with Hemp and LavenderHISTAMINE DIHYDROCHLORIDEBAKER'S BEST HEALTH PRODUCTS, INC.03ec87c5-6669-4afb-8d9c-c8dc9907495d2023-11-06WarningsExact identifier
application number: M017
DOCTORS TOUCH Erase The PainMENTHOLDOCTOR'S CHOICE MEDICAL, LLCfe9ce2c7-d6af-4dad-b6e6-5049a9e091b02023-11-06WarningsExact identifier
application number: M017
RadiaGuard Advanced Radiation ReliefLIDOCAINE HYDROCHLORIDESMOOTH SIDE, INC21205087-5a2e-41a5-be40-30cba28954082023-11-06WarningsExact 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