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
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
b44beac3-1d20-434f-9a79-4fab1ac68791Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-006-01ZIMS MAX FREEZE PRO FORMULA113 g in 1 TUBEGEL1137
54273-006-02ZIMS MAX FREEZE PRO FORMULA136 g in 1 TUBEGEL1367
54273-006-03ZIMS MAX FREEZE PRO FORMULA5 g in 1 PACKETGEL57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-006ZIMS MAX FREEZE PRO FORMULA (MENTHOL, UNSPECIFIED FORM) GEL [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]7Current NDC, Legacy NDC, 3 package rows20231116_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 147 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BLUE SPRING Foot and Leg ComfortMENTHOLACA MANAGEMENT LLC5f52218d-eea4-4640-b820-84c077ab98ba2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Red Hot Pepper Pain Relief CreamMENTHOL, CAPSAICINACA MANAGEMENT LLC36293885-b2dd-4fba-9748-35a3c9e050782023-11-06WarningsExact identifier
application number: M017
ROPANA Pain Relief CreamHISTAMINE DIHYDROCHLORIDEFUSION PAIN SOLUTIONS LLCe0342aa3-ca80-40b7-bec6-1b33c4db398b2023-11-06WarningsExact identifier
application number: M017
EMU THERAPY Cool Menthol Therapy Pain Relief CreamMENTHOLACA MANAGEMENT LLC16894346-3513-41b1-b09f-72d84edcc4ac2023-11-06WarningsExact identifier
application number: M017
SKINS DELAY Climax Control LidocaineLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED0db91010-12f7-4f20-b96c-432915720d5a2023-11-06WarningsExact identifier
application number: M017
POWERECT Lidocaine Male DelayLIDOCAINE HYDROCHLORIDESKINS SEXUAL HEALTH LIMITED42e0c40f-1efd-45ef-815d-53d193d720eb2023-11-06WarningsExact identifier
application number: M017
ARTHRO LIFE Instant Pain Relief CreamMENTHOLBIOBEST SERVICES LLC66eb1a78-6861-4693-b68e-bd4a664fc0752023-11-06WarningsExact identifier
application number: M017
PARACTIN QuantumActiv Pain Relief CreamMENTHOLNHR SCIENCE CORPae2f89cf-120c-4c6f-9e81-4560e6fa03732023-11-06WarningsExact identifier
application number: M017
FISICO Arthrozene Pain CreamMENTHOLFISICO INC.d02c4349-78dd-4672-9582-50124ea9f1e12023-11-06WarningsExact identifier
application number: M017
BRONSON SOOTHE Pain ReliefCAPSAICINBRONSON NUTRITIONALS, LLCcedf8f43-b9a3-4a06-b3a1-cf82668541f82023-11-06WarningsExact identifier
application number: M017
INTIMALE Benzocaine Delay GelBENZOCAINESKINS SEXUAL HEALTH LIMITEDb845bfd5-ab73-495f-97ef-e959bc6311d92023-11-06WarningsExact identifier
application number: M017
RAPID PAIN-RELIEF TOPICALLIDOCAINE HYDROCHLORIDE, MENTHOLNORDIC HEALTHY LIVING INC.a06d6aca-9aa2-4bbe-bf77-4c85f1dd78702023-11-06WarningsExact identifier
application number: M017
PURE PERSONAL All Natural Pain Relief CreamMENTHOLPURE PERSONAL CARE, LLC8f3fb1d0-d238-4b4c-9816-7e335258d71d2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLC89c80a8f-227d-4ec0-9327-683892e73b6a2023-11-06WarningsExact identifier
application number: M017
DIRT Pain Relieving GelMENTHOLPURIVITAE, LLCe43e2cbd-d114-4b11-8baf-7a775881cd972023-11-06WarningsExact identifier
application number: M017
Celadrin Joint and Muscle Pain RelievingMENTHOLFactors Group of Nutritional Products6396e4b6-2130-433b-bdb3-97c76dbe685c2023-11-06WarningsExact identifier
application number: M017
Atomic BalmMETHYL SALICYLATE, CAPSAICINThe Hygenic Company, LLCd10028f3-ae6a-7b01-e053-2995a90a5a842023-11-05WarningsExact identifier
application number: M017
HEMPCIN Advanced Topical Pain Relief CreamMENTHOLPedicis Research, LLC97f5e300-b780-4694-a681-60d5e0cfad652023-11-05WarningsExact identifier
application number: M017
Point Relief cold Spot Pain Relieving roll-onMENTHOLFabrication Enterprises3f1db0ad-aaa8-4e14-9349-45057e0fb4a62023-11-05WarningsExact identifier
application number: M017
LidoStatLIDOCAINE HCLClinical Therapeutic Solutions1825885b-9141-4515-bb69-a1c4a39fb10d2023-11-05WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311509menthol 7 % Topical GelPSNb44beac3-1d20-434f-9a79-4fab1ac687917
311509menthol 0.07 MG/MG Topical GelSCDb44beac3-1d20-434f-9a79-4fab1ac687917
311509menthol 7 % Topical GelSYb44beac3-1d20-434f-9a79-4fab1ac687917

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54273-006-0154273000601113 g in 1 TUBE (54273-006-01) 113 g2018-07-010000-00-00NoNoCurrent
54273-006-0254273000602136 g in 1 TUBE (54273-006-02) 136 g2019-02-010000-00-00NoNoCurrent
54273-006-03542730006035 g in 1 PACKET (54273-006-03) 5 g2019-01-010000-00-00NoNoCurrent