JUST CBD ROLL-ON COOLING

Product NDC
73647-400
11-digit product format
736470400
Labeler code
73647
Product ID
73647-400_43d6cabe-dcfa-512b-e063-6394a90a225b
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Just Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-14
Marketing end
2027-06-03
Substance
MENTHOL
Active strength
4 g/100mL
NDC exclude flag
No
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
JUST CBD ROLL-ON COOLING

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6538e3e-4663-679c-e053-2995a90a87b5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73647-400-03JUST CBD ROLL-ON COOLING89 mL in 1 BOTTLEGEL895

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73647-400JUST CBD ROLL-ON COOLING (MENTHOL) GEL [JUST BRANDS LLC]4Current NDC, 1 package rows20240510_f6538e3e-4663-679c-e053-2995a90a87b5.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 59 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact identifier
application number: M017
Sohm Pain AwayMENTHOL, CAMPHORSOHM, Inc86632acf-80ae-48d7-a0bb-7ec980326bae2025-11-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Pain ReliefLIDOCAINE 4%Veridian Healthcare6f2332c0-e078-40a8-9564-f47d21bc491b2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON WARMINGCAMPHORJust Brands LLC44779065-5f57-8f01-e063-6394a90a3f8e2025-11-25WarningsExact identifier
application number: M017
JUST CBD ROLL-ON COOLINGMENTHOLJust Brands LLC44786cb6-176e-cc6e-e063-6394a90a54ad2025-11-25WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFVALU MERCHANDISERS, CO3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff2025-11-24WarningsExact identifier
application number: M017
MentholMAXIMUM STRENGTH MEDICATED FOOT POWDERVALU MERCHANDISERS, CO89a5c4bb-442f-d3f0-e053-2a95a90a51bd2025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d11ab8e-d3ea-c7ef-e063-6294a90ae0a32025-11-24WarningsExact identifier
application number: M017
Dragon Pain RelievingCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d113dec-8832-d984-e063-6394a90ae7b32025-11-24WarningsExact identifier
application number: M017
Dragon Pain Relieving BalmCAMPHOR, MENTHOLAMERICANNA WELLNESS, INC.0d12f03f-dd8b-0be5-e063-6294a90a43db2025-11-24WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief GelTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GELClarion Brands LLC445db02a-c8e8-6ebb-e063-6294a90a43012025-11-24WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73647-400-037364704000389 mL in 1 BOTTLE (73647-400-03) 89 ml2023-03-142027-06-03NoNoHistorical