ZIMS MAX FREEZE

Product NDC
54273-008
11-digit product format
542730008
Labeler code
54273
Product ID
54273-008_7603d7df-335d-432b-b747-6a955119973b
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
SPRAY
Route
TOPICAL
Labeler
KOBAYASHI Healthcare International, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-24
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
160 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZIMS MAX FREEZE PRO FORMULAMENTHOLKOBAYASHI Healthcare International, Inc.08dcfa78-7332-4f19-90d7-fdd7d446848a2023-11-16WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only Rare cases of burns have been reported with products of this type Flammable keep away from fire or flame and heated surfaces do not use near sparks or while smoking do not use in a small or confined space avoid long term storage above 104° F (40° C) do not puncture or incinerate. Contents under pressure. do not expose to temperature exceeding 119° F (48° C) Do not use if you are allergic to any ingredient in this product on open wounds, damaged or irritated skin with a heating pad or TENS device near face after expiration date When using this product may cause a burning sensation wherever it is applied, but is usually mild and gradually lessens over time do not bandage tightly do not use otherwise than as directed avoid contact with eyes or mucous membranes avoid inhalation Stop use and ask a doctor if burning sensation is painful and persistent condition worsens rash, itching, redness or excessive irritation of the skin develops symptoms persist for more than 7 days symptoms clear up and occur again within a few days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 FORM160 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1430458

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54273-008-01ZIMS MAX FREEZE PRO FORMULA96 g in 1 CANSPRAY965
54273-008-02ZIMS MAX FREEZE PRO FORMULA116 g in 1 CANSPRAY1165

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54273-008ZIMS MAX FREEZE PRO FORMULA (MENTHOL) SPRAY [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.]5Current NDC, Legacy NDC, 2 package rows20231117_08dcfa78-7332-4f19-90d7-fdd7d446848a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1430458menthol 16 % Topical SprayPSN08dcfa78-7332-4f19-90d7-fdd7d446848a5
1430458menthol 160 MG/ML Topical SpraySCD08dcfa78-7332-4f19-90d7-fdd7d446848a5
1430458menthol 16 % Topical SpraySY08dcfa78-7332-4f19-90d7-fdd7d446848a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54273-008-015427300080196 g in 1 CAN (54273-008-01) 96 g2018-09-240000-00-00NoNoCurrent
54273-008-0254273000802116 g in 1 CAN (54273-008-02) 116 g2019-02-010000-00-00NoNoCurrent