COOL BREEZE Pain Relief

Product NDC
72744-433
11-digit product format
727440433
Labeler code
72744
Product ID
72744-433_09135640-d8a9-790c-e063-6294a90a8fce
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
COOL BREEZE US LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-13
Substance
MENTHOL
Active strength
51 mg/mL
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
COOL BREEZE Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL51 mg/mL

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
2669723Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
14dcf4ee-6778-49d4-8601-9205737432eaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72744-433-00COOL BREEZE Pain Relief118 mL in 1 TUBEGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72744-433COOL BREEZE PAIN RELIEF (MENTHOL) GEL [COOL BREEZE US LLC]1Current NDC, 1 package rows20231114_14dcf4ee-6778-49d4-8601-9205737432ea.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 33 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tylenol Precise Cooling Pain RelievingLIDOCAINE, MENTHOLKenvue Brands LLCfc0a3404-b174-3952-e053-6294a90a1e022026-02-16WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCLValu Merchandisers Company87ee2b4f-d640-4cec-9f48-1d8aa54434e92026-02-16Warnings, Adverse reactionsExact identifier
application number: M017
Hemp Magic Fast-Acting Pain Relief CreamMENTHOLNexxus Capital LLC4af69640-1413-868b-e063-6394a90a39892026-02-16WarningsExact identifier
application number: M017
RelaxInk LIDOCAINELIDOCAINE 4%Hambli Limited49a1cf66-9bb1-b918-e063-6394a90a2ff62026-02-15WarningsExact identifier
application number: M017
blue goo Pain RelievingMENTHOL 2.5%Garcoa, Inc.7b9b5ac6-9568-464c-8096-0302a1e650df2026-02-13WarningsExact identifier
application number: M017
Methyl Salicylate 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLTopco Associates LLC80962394-a46f-48fd-8e0c-685dd1e500d72026-02-13Warnings, Adverse reactionsExact identifier
application number: M017
BanophenDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEMajor Pharmaceuticals9758d886-bd58-4eb2-a827-fa8e7fee2b7c2026-02-13WarningsExact identifier
application number: M017
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINAlexso, Inc6d0bc1cc-e812-4753-b20c-c0357dd6deb52026-02-13WarningsExact identifier
application number: M017
Swiftalyn Numbing CreamLIDOCAINE 4%GENUINE INNOVATION LTD3f74c4a6-26f0-ddf7-e063-6394a90a12252026-02-12WarningsExact identifier
application number: M017
PHARMBANNER Arnica Bruise CreamARNICA BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3c783061-8e2d-8a84-e063-6394a90a52652026-02-12WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAIN RELIEF WITH HEMPMENTHOL, CAMPHORWorldwide Cosmetics, Inc459d64a9-0538-57c8-e063-6394a90a61552026-02-12WarningsExact identifier
application number: M017
Antiseptic Mouth RinseEUCALYPTOLWalgreen Co.cba60e9d-5f12-4c56-9fa5-6ce1514fc2b02026-02-12Warnings, Adverse reactionsExact identifier
application number: M017
Medicated Body PowderMENTHOLWalmart Stores Incafd337b7-d76e-f17a-e053-2a95a90abac72026-02-12WarningsExact identifier
application number: M017
Lidocaine Hydrochloride 2%LIDOCAINE HYDROCHLORIDEAldermed Inc.4977b722-d08d-3d9e-e063-6294a90a90352026-02-12WarningsExact identifier
application number: M017
Ice Gel ICE COLD ANALGESICMENTHOLJell Pharmaceuticals Pvt Ltd4a8b3f84-8c45-eb94-e063-6394a90a3e732026-02-11WarningsExact identifier
application number: M017
Walgreens Pain Relieving Lidocaine PatchLIDOCAINEWalgreen Co.41c4e9fe-e407-b22a-e063-6394a90a4b272026-02-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE CREAM 1%Aldermed Inc.4a7f2c0e-5cf3-29cb-e063-6394a90a5d8d2026-02-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2669723menthol 5.1 % Topical GelPSN14dcf4ee-6778-49d4-8601-9205737432ea1
2669723menthol 0.051 MG/MG Topical GelSCD14dcf4ee-6778-49d4-8601-9205737432ea1
2669723menthol 5.1 % Topical GelSY14dcf4ee-6778-49d4-8601-9205737432ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72744-433-0072744043300118 mL in 1 TUBE (72744-433-00) 118 ml2023-11-13NoNoCurrent