Quality Choice Cold Therapy Gel

Product NDC
83324-007
11-digit product format
833240007
Labeler code
83324
Product ID
83324-007_4721fb64-bc29-b450-e063-6294a90a056e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Chain Drug Marketing Association, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-01
Substance
MENTHOL
Active strength
40 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Quality Choice Cold Therapy Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL40 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
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f9c659cd-e7fa-ac2d-e053-6294a90a2573Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-007-04Quality Choice Cold Therapy Gel118.2 mL in 1 BOTTLEGEL118.24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83324-007-04ML - Milliliter83324-0070eea5273-a298-4f02-859c-b58e996c9c5612026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83324-007QUALITY CHOICE COLD THERAPY GEL (MENTHOL) GEL [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Current NDC, 1 package rows20240327_f9c659cd-e7fa-ac2d-e053-6294a90a2573.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 111 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEWalgreen Companydb8cf218-7544-4871-b1c3-a50a3d3e59f12024-12-17WarningsExact identifier
application number: M017
Albertsons Pain Relief PatchLIDOCAINESafewaydc2823bb-8586-daca-e053-2995a90a2af02024-12-17WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINWalgreen Companye77167ab-6cb8-4d5b-838c-b0acc05e38892024-12-17WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLWalgreen Companyd9fc133d-ebaa-48f1-a6f9-62453970012b2024-12-17WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company204b96bc-af4e-4842-8b57-7b416feb4dd92024-12-17WarningsExact identifier
application number: M017
Lidocaine DryLIDOCAINECVSbb7955fe-5113-1662-e053-2a95a90a85a12024-12-16WarningsExact identifier
application number: M017
HealthWise Medicated Original Body Powder 10 ozMENTHOLVeridian Healthcare296b623a-14cd-0bca-e063-6394a90ac5ff2024-12-16WarningsExact identifier
application number: M017
HealthWise Medicated Extra Body Powder 10 ozMENTHOLVeridian Healthcare296c9a9c-e3db-59fe-e063-6294a90a0b622024-12-16WarningsExact identifier
application number: M017
Rite Aid Hot and Cold Roll OnMENTHOL 16%Rite Aidfc4b2635-280b-267f-e053-6294a90a5e222024-12-15WarningsExact identifier
application number: M017
Rite Aid Pain RelievingBENZOCAINE 20%, MENTHOL 0.5%Rite Aide2c09e85-be0a-4e6d-e053-2995a90ad7562024-12-15WarningsExact identifier
application number: M017
Rugby LidocaineLIDOCAINE 4%Rugby Laboratoriesd94292f7-10fc-48bf-e053-2995a90a84722024-12-15WarningsExact identifier
application number: M017
Rite Aid CortisoneHYDROCORTISONE 1%Rite Aide27353b9-23b6-3801-e053-2a95a90a60452024-12-15WarningsExact identifier
application number: M017
Rite Aid Cooling Pain ReliefMENTHOL 10.5%Rite Aide2225259-70ec-52de-e053-2a95a90a73f82024-12-15WarningsExact identifier
application number: M017
Rite Aid Rectal CareLIDOCAINE 5%Rite Aide283e462-96e8-04cf-e053-2a95a90a1d002024-12-15WarningsExact identifier
application number: M017
Rite Aid Anti-ItchDIPHENHYDRAMINE HCL 2%Rite Aide33898d8-1b8b-5c0b-e053-2995a90add082024-12-15WarningsExact identifier
application number: M017
Rite Aid Cala Itch ReliefPRAMOXINE HCL 1%, ZINC ACETATE 0.1%Rite Aide29a9d59-4c7c-81aa-e053-2995a90a70562024-12-15WarningsExact identifier
application number: M017
CVS Roll-OnCAPSAISIN 0.1%CVSe8812c49-335e-61ea-e053-2995a90a17aa2024-12-15WarningsExact identifier
application number: M017
Good Sense Burn Relief AloeLIDOCAINE HCLGeiss, Destin & Dunn, Incb5a7f629-a88d-b49d-e053-2995a90a49fa2024-12-15WarningsExact identifier
application number: M017
QC Burn Relief AloeLIDOCAINE HCLChain Drug Marketing Association Incb5e76f0c-0bfe-b13e-e053-2995a90a08612024-12-15WarningsExact identifier
application number: M017
Meijer Burn ReliefLIDOCAINE 0.5%Meijerbec60c93-5abd-ee04-e053-2a95a90acb612024-12-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSNf9c659cd-e7fa-ac2d-e053-6294a90a25734
415974menthol 0.04 MG/MG Topical GelSCDf9c659cd-e7fa-ac2d-e053-6294a90a25734
415974menthol 4 % Topical GelSYf9c659cd-e7fa-ac2d-e053-6294a90a25734

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-007-0483324000704118.2 mL in 1 BOTTLE (83324-007-04) 118.2 ml2023-04-01NoNoCurrent