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 44 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HCILIDOCAINE HCITrifluent Pharma, LLC47f7f06b-720e-eeec-e063-6294a90ae8232026-01-09WarningsExact identifier
application number: M017
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsExact identifier
application number: M017
TetracaineTETRACAINEBellus Medical, LLC60cabb5f-606b-7a74-e053-2a91aa0ac0242026-01-09WarningsExact identifier
application number: M017
BenzocaineBENZOCAINEBellus Medical, LLC60cafbaf-8ec6-46a5-e053-2a91aa0af11f2026-01-09WarningsExact identifier
application number: M017
PRAXPRAMOXINE HYDROCHLORIDEAvPAKdc646399-91ba-5cc1-e053-2a95a90a4f9c2026-01-09WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLCc842544a-6aea-42af-a77e-7b202371b3872026-01-09WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLUniversal Distribution Center LLC7fb95135-4151-4ef4-bb6d-75251cafff6c2026-01-09WarningsExact identifier
application number: M017
Meijer Extra Strength Cold And Hot TherapyPain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEMeijer Distribution, Inc781f89c0-94ab-48de-9e0b-decb37bcde462026-01-09WarningsExact identifier
application number: M017
LIDOCAINE PAIN RELIEVING Gel-PatchLIDOCAINEGuangzhou Zhupuyou E-commerce Co., Ltd2159fb73-cf6c-184a-e063-6394a90a1d142026-01-08WarningsExact identifier
application number: M017
PAIN RELIEF Gel-PatchLIDOCAINE, MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd22d9ce20-1cb6-c5bd-e063-6394a90a9eca2026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INT'L THERMO ANALGETICS ROLL-ON76ef713b-e23d-7b98-e053-2991aa0aad512026-01-08WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO INTERNATIONAL, INCbbf0ca84-2800-d222-e053-2995a90ad8f32026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5b0db6-8f0a-4f8e-e053-2995a90a22b72026-01-08WarningsExact identifier
application number: M017
Capsaicin Topical AnalgesicCAPSAICINAvPAKef597423-cd01-7324-e053-2a95a90aa1ba2026-01-08WarningsExact identifier
application number: M017
Capsaicin External AnalgesicCAPSAICINAvPAKef5a3846-1d2f-7023-e053-2a95a90ad7162026-01-08WarningsExact identifier
application number: M017
CapsaicinCAPSAICINAvPAKef5bb0fa-afc2-62d7-e053-2a95a90a37f42026-01-08WarningsExact identifier
application number: M017
K2 Cold TherapyMENTHOLThe Podiatree Co60dce1ad-125e-396d-e053-2a91aa0a670f2026-01-08WarningsExact identifier
application number: M017
Burn Relief AloeLIDOCAINE HCLAcutens48c435fe-2670-4b80-bf01-923dc93544222026-01-08WarningsExact identifier
application number: M017
Relieve A PainLIDOCAINERelieve A Pain LLCcafaa830-d894-4590-8928-d579cc791d792026-01-08WarningsExact identifier
application number: M017
DZUL ARTHRITIS PAIN RELIEFMENTHOLCaball Sales, Inc.159c301c-d462-bb2c-e063-6394a90a9e5a2026-01-08WarningsExact 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