FDA.reportPublic FDA data

Freeze Ease Max Cream

Product NDC
87843-313
11-digit product format
878430313
Labeler code
87843
Product ID
87843-313_18e60a51-3d24-4570-b2a5-99dc2ecb2bd1
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 10.5%
Dosage form
CREAM
Route
TOPICAL
Labeler
Global America Group LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-09-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
10.5 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct87843-313DDiscontinued by firm2026-10-16
excluded packagepackage87843-31387843-313-95DDiscontinued by firm2026-10-16

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
Freeze Ease Max Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM10.5 g/100g

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 38 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare Muscle and Joint Gel Vanishing ScentMENTHOL 2.5%Veridian Healthcare494d2a85-45a8-12a2-e063-6294a90a391b2026-01-26WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINETrifecta Pharmaceuticals USA, LLC.493c09d0-16d7-7413-e063-6394a90aa0522026-01-26WarningsExact identifier
application number: M017
Topcare Medicated Pain Relieving Patch 60ctTOPCARE PAIN RELIEF PATCH EXTRA STRENGTHTopco Associates LLC4953c12b-ca6d-d21e-e063-6294a90ac9902026-01-26WarningsExact identifier
application number: M017
Dr SabharwalsMENTHOL 5% PATCHDr. Sabharwal's Wound Care1025b986-a1e5-701d-e063-6294a90a33fd2026-01-24WarningsExact identifier
application number: M017
Target Up and Up Pain Relief Menthol Topical AnalgesicMENTHOLTarget Corporation4910f32f-c639-0215-e063-6394a90a1c7b2026-01-23WarningsExact identifier
application number: M017
RapidolHYDROCORTISONEPharmadel LLC19a1f1e2-bc6b-7153-e063-6294a90ab1152026-01-23WarningsExact identifier
application number: M017
CVS 9083 Maximum Strength Lidocaine 4 Pain Relief Patch 1ct LargeLIDOCAINECVS PHARMACY, INC4914965f-1164-e20e-e063-6294a90ac2212026-01-23WarningsExact identifier
application number: M017
THE GOO MEDICATED PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAPSM PERFORMANCE, LLCdb4c321c-8cdc-5a11-e053-2995a90a91a12026-01-23WarningsExact identifier
application number: M017
Dr SabharwalsLIDOCAINE 4% AND MENTHOL 1% PATCHDr. Sabharwal's Wound Care10249d0f-5ee1-6892-e063-6394a90a967e2026-01-23WarningsExact identifier
application number: M017
Easment DMSO creamMENTHOL 1.00%Easment LLC48f5544e-1cfd-864a-e063-6394a90a71f12026-01-22WarningsExact identifier
application number: M017
Aveeno 1% Hydrocortisone Anti-Itch CreamHYDROCORTISONEKenvue Brands LLC1ac0ac4e-af76-9a3e-e063-6394a90a12692026-01-22WarningsExact identifier
application number: M017
RAYO ACTIVE ICEMENTHOL, CAMPHORQuimicas Handal de Centroamerica SA de CV09e4a36b-020a-c5b1-e063-6394a90a3e312026-01-22WarningsExact identifier
application number: M017
X-Treme FreezeCOLD THERAPY GELDynarex Corporation79f0802f-03ad-bf8f-e053-2991aa0ae4b52026-01-22WarningsExact identifier
application number: M017
Anti ItchHYDROCORTISONEHyVee Incae31f1f5-db70-45cf-850e-67bfe68607482026-01-21WarningsExact identifier
application number: M017
ULTRA RELIEFMENTHOL, CAMPHORCHEMCO CORPORATION48ea80cf-af54-ce5f-e063-6394a90ac4932026-01-21WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICEagle Labs Inc.17dff3c1-3c0b-16f6-e063-6394a90a3c052026-01-21WarningsExact identifier
application number: M017
Pain ReliefANALGESICFullstack Fulfillment2a433cee-8b6f-c280-e063-6394a90ae25a2026-01-21Exact identifier
application number: M017
Walgreens Anti Itch CreamANTI ITCH CREAMWalgreens Companyb545553a-283a-48af-adc5-763758a9ff242026-01-21WarningsExact identifier
application number: M017
CVS Health Maximum Strength Lidocaine Pain Relief Cream Plus MentholLIDOCAINE HCL, MENTHOLCVS Pharmacy8aaffa3f-f82f-470c-902d-f366f1a663052026-01-21WarningsExact identifier
application number: M017
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87843-313-1287843031312120 g in 1 BOTTLE, PUMP (87843-313-12) 120 g2026-09-01NoNoCurrent