FDA.reportPublic FDA data

JUST CBD ROLL-ON WARMING

Product NDC
73647-040
11-digit product format
736470040
Labeler code
73647
Product ID
73647-040_43d6d4ed-0942-5296-e063-6394a90a0a12
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR
Dosage form
GEL
Route
TOPICAL
Labeler
Just Brands LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-14
Marketing end
2027-05-14
Substance
CAMPHOR (NATURAL)
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 WARMING

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)4 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f65455d7-04a9-6217-e053-2995a90a7c90Available 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
73647-040-03JUST CBD ROLL-ON WARMING89 mL in 1 BOTTLEGEL895

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73647-040JUST CBD ROLL-ON WARMING (CAMPHOR) GEL [JUST BRANDS LLC]4Current NDC, 1 package rows20240502_f65455d7-04a9-6217-e053-2995a90a7c90.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 134 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
application number: M017
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
application number: M017
Maximum Strength Scalp Itch Relief Anti-itchHYDROCORTISONERite Aid55569563-fc38-4f97-8e74-9f96e31733842024-02-28WarningsExact identifier
application number: M017
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
application number: M017
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact identifier
application number: M017
SunBurnt PLUSLIDOCAINE HYDROCHLORIDEQuest Products, LLC.12128c75-015d-8a72-e063-6394a90ae00a2024-02-23WarningsExact identifier
application number: M017
Kroger Analgesic AnalgesicLIDOCAINE HYDROCHLORIDETHE KROGER COe6c5ead3-87d0-48ed-a4dc-86cf89ebb2852024-02-22WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEBryant Ranch Prepackfcf48536-224e-4a3d-9124-7700318239722024-02-22WarningsExact identifier
application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc8bc3956b-b82d-4ed3-8bc3-db0078466bbc2024-02-22WarningsExact identifier
application number: M017
Promescent Delay WipesBENZOCAINEAbsorptionf0a5b6be-acc5-473c-9054-b9534e769db12024-02-20WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.721658dc-3b1d-43ff-9032-e96851633cf92024-02-19WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
73647-040-037364700400389 mL in 1 BOTTLE (73647-040-03) 89 ml2023-03-142027-05-14NoNoHistorical