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 146 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f92e71-fe2e-16f4-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M017
Teeter Renew Muscles Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCb90dc5b9-c31d-4770-a291-98d036ae87232023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR Foot and Leg RubCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC57094238-506b-48c1-8eb9-fe904be80df02023-11-10WarningsExact identifier
application number: M017
SKIN A COOL Hydrocortisone Anti-ItchHYDROCORTISONEAna-Cool, LLCe3ea7406-e494-4038-9b28-8d0a28b4b8342023-11-10WarningsExact identifier
application number: M017
Teeter reNEW MUSCLES Pain RelievingMETHYL SALICYLATE, MENTHOLSTL International INCebc777b0-d141-4a62-9366-d14787eaefe02023-11-10WarningsExact identifier
application number: M017
FEELGOOD LAB Natural Pain CreamMENTHOLThe Feel Good Lab, LLC799d464c-aaf1-429a-877b-2a692397bb492023-11-10WarningsExact identifier
application number: M017
HIGHER CONTROL Male Climax Control LubricatingBENZOCAINEProduct Max Group Inc5f5fd127-34c5-403a-aa95-c9874ae794922023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f93076-1f68-58e6-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f9622e-27c7-6a5d-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
FEEL GOOD LAB Natural Pain CreamMENTHOLTHE FEEL GOOD LAB, LLC774a72b1-b719-4217-846e-7f9921fd1b162023-11-10WarningsExact identifier
application number: M017
BODY ACTION PRODUCTS Climax Control GelBENZOCAINEPRODUCT MAX GROUP INC53e746cc-0078-4381-bf0b-9c8f98d669042023-11-10WarningsExact 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