FDA.reportPublic FDA data

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 61 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nighttime 4X Medicated CreamBENZOCAINERite Aid21645ed1-2dc0-223a-e063-6394a90ab0212025-11-21WarningsExact identifier
application number: M017
4x Medicated Gum CreamBENZOCAINEAlbertsonsb81a308c-9c30-0e3d-e053-2a95a90a15d22025-11-21WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCb0edd9d9-951f-d3dd-e053-2995a90a8d5a2025-11-21WarningsExact identifier
application number: M017
Up upLIDOCAINE PAIN RELIEF MAXIMUM STRENGTH PATCHESTarget Corporation44121d40-86e1-0df6-e063-6294a90aedaf2025-11-20WarningsExact identifier
application number: M017
Up upPAIN RELIEF ADVANCED HYDROGEL PATCHESTarget Corporation44128b70-3172-ee37-e063-6294a90a705f2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCf03090fa-f7e6-f53a-e053-2a95a90aa8192025-11-20WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INCff073e47-3107-e17e-e053-6294a90a58fa2025-11-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET NOVELTIES, INCfc8a8f20-97ab-481e-e053-6394a90a35252025-11-20WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF ROLL-ON 3OZ934d4638-b47b-187d-e053-2995a90ae69d2025-11-20WarningsExact identifier
application number: M017
FOOT PAIN RELIEF ROLL-ONLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd43edcea0-ab04-f368-e063-6294a90a817a2025-11-19WarningsExact identifier
application number: M017
Absolut Skin Corticosoothe Anti-ItchHYDROCORTISONEAbsolut Skin Incorporateddeb52218-9176-4aaa-a22f-b66dada6690f2025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch Good Neighbor PharmacyLIDOCAINEInterMed Laboratories Private Limited43f3d189-f6b7-02ed-e063-6394a90afd732025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch HealthA2ZLIDOCAINEInterMed Laboratories Private Limited43f3e288-e828-8130-e063-6394a90a6d442025-11-19WarningsExact identifier
application number: M017
Maximum Strength 4% Lidocaine Patch LeaderLIDOCAINEInterMed Laboratories Private Limited42f06914-c8b8-ea9c-e063-6294a90a79e62025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchCAMPHOR, MENTHOLCVS87715662-c788-9a8d-e053-2a95a90acb532025-11-19WarningsExact identifier
application number: M017
Walgreen Anti ItchCAMPHOR, MENTHOLWalgreensb4f47a8d-d4a6-9233-e053-2a95a90afd902025-11-19WarningsExact identifier
application number: M017
Leader Anti-ItchCAMPHOR, MENTHOLLEADER/Cardinal Helath 110, Inc.9ca985c6-5017-0558-e053-2995a90a82022025-11-19WarningsExact identifier
application number: M017
CVS Anti-ItchPRAMOXINE HCLCVS87fc476a-5b12-7383-e053-2995a90a530b2025-11-19WarningsExact identifier
application number: M017
Walgreen Anti-ItchPRAMOXINE HCLWalgreensb5f9d1c5-891e-4377-e053-2995a90aa2812025-11-19WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF89f5f688-856f-f2df-e053-2995a90a73cf2025-11-19WarningsExact 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