FDA.reportPublic FDA data

Pain Reliever

Product NDC
84733-302
11-digit product format
847330302
Labeler code
84733
Product ID
84733-302_43828e33-3763-a578-e063-6294a90af9ed
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
Kool 'N Fit Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-11
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
.2; 1.25 g/100g; g/100g
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
Pain Reliever
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC).2 g/100g
MENTHOL1.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5TJD82A1ETInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1923699Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2253f6bd-5707-b993-e063-6394a90aa74aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84733-302-01Pain Reliever3785 g in 1 BOTTLESPRAY37853
84733-302-02Pain Reliever59.145 g in 1 BOTTLE, SPRAYSPRAY59.1453
84733-302-04Pain Reliever236.58 g in 1 BOTTLE, SPRAYSPRAY236.583
84733-302-08Pain Reliever118.29 g in 1 BOTTLE, SPRAYSPRAY118.293
84733-302-16Pain Reliever473.17 g in 1 BOTTLESPRAY473.173

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84733-302PAIN RELIEVER (CAMPHOR, MENTHOL) SPRAY [KOOL 'N FIT INC.]1Current NDC, 5 package rows20241012_2253f6bd-5707-b993-e063-6394a90aa74a.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 69 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Cold and Hot MedicatedMENTHOLTopco Associates LLC8739aedd-165c-5ae0-e053-2a91aa0afcd02025-10-31WarningsExact identifier
application number: M017
CVS Medicated Heat 1 ctCAPSAICINCVS Pharmacy, Inc.d41dce5b-e698-4930-8869-040b2a973f252025-10-31WarningsExact identifier
application number: M017
Coralite Medicated HeatCAPSAICINUnited Exchange Corp.a0b89c7e-80bc-43c4-840c-5fd567f60b212025-10-31WarningsExact identifier
application number: M017
Dragon with Arnical Pain ReliefMENTHOLGenomma Lab USA Inc.b4cbb7b6-cb71-9721-e053-2995a90a2b2c2025-10-31WarningsExact identifier
application number: M017
Hydrocortisone Anti-ItchHYDROCORTISONEUniversal Distribution Center LLC186afb11-06b6-4bfa-e063-6294a90aefc62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY SOLID Ointment.GEMACHLICH ZUHAUSE NEUROPATHY SOLID OINTMENT.Guangdong Quadrant Ecological Technology Co., Ltd.425b1b9d-c33a-05e9-e063-6394a90a97a62025-10-30WarningsExact identifier
application number: M017
Gemachlich ZuHause NEUROPATHY Spray.GEMACHLICH ZUHAUSE NEUROPATHY SPRAY.Guangdong Quadrant Ecological Technology Co., Ltd.425b8259-af38-8d68-e063-6394a90a11202025-10-30WarningsExact identifier
application number: M017
Family Care Muscle and JointMENTHOLUnited Exchange Corp.959af9f4-7188-91a1-e053-2995a90a46652025-10-30WarningsExact identifier
application number: M017
CVS Maximum Strength Boil ReliefBENZOCAINECVS Pharmacy, Inc.0761b866-af34-42bd-adc9-3d229170d01c2025-10-30WarningsExact identifier
application number: M017
CVS Cold and HotMENTHOLCVS Pharmacya44ca52d-fec8-0e8c-e053-2995a90a2e602025-10-30WarningsExact identifier
application number: M017
CVS CAPSAICINCAPSAICINCVS PHARMACY9b551fe3-3842-482a-9042-63de5ad398842025-10-30WarningsExact identifier
application number: M017
TopCare Health Pain ReliefMENTHOL, CAMPHOR, AND METHYL SALICYLATETopco Associates LLCdac364ef-6dcd-3fc6-e053-2a95a90a9bb22025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLAmerisourceBergen Drug Corporationf161e151-4fab-2fbc-e053-2a95a90a54372025-10-30WarningsExact identifier
application number: M017
LidocaineBURN RELIEFPerrigo Directc7b50f14-3481-9ebd-e053-2995a90afe1c2025-10-30WarningsExact identifier
application number: M017
Lipoflavonoid Ear Pain Kids Relief DropsLIPOFLAVONOID EAR PAIN KIDS RELIEF DROPSClarion Brands LLC4265361b-5526-c3e0-e063-6394a90a17772025-10-30WarningsExact identifier
application number: M017
Diphenhydramine HCl and Zinc AcetateEXTRA STRENGTH ITCH RELIEFHEB2aedbf1d-c8b7-4d5d-83ee-e38872c37d4f2025-10-30WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYMeijer Distribution Inc.28daaf97-b0b3-7a54-e063-6294a90a23f12025-10-30WarningsExact identifier
application number: M017
Calamine PlusCALAMINE PLUS PRAMOXINE HCLMeijer Distribution Inc.03c46823-0b1f-4101-e063-6294a90aaf942025-10-30WarningsExact identifier
application number: M017
Extra Strength Itch ReliefDIPHENHYDRAMINE HCL AND ZINC ACETATEMeijer Distribution Inc02f9e270-6047-83b6-e063-6394a90afc272025-10-30WarningsExact identifier
application number: M017
Muscle Rub Pain Reliever GelMENTHOL, UNSPECIFIED FORMUniversal Distribution Centre LLC18536e21-afc3-8447-e063-6394a90aabae2025-10-30WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1923699camphor 0.2 % / menthol 1.25 % Topical SprayPSN2253f6bd-5707-b993-e063-6394a90aa74a3
1923699camphor 2 MG/ML / menthol 12.5 MG/ML Topical SpraySCD2253f6bd-5707-b993-e063-6394a90aa74a3
1923699camphor 0.2 % / menthol 1.25 % Topical SpraySY2253f6bd-5707-b993-e063-6394a90aa74a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84733-302-01847330302013785 g in 1 BOTTLE (84733-302-01) 3785 g2024-10-11NoNoCurrent
84733-302-028473303020259.145 g in 1 BOTTLE, SPRAY (84733-302-02) 59.145 g2025-09-05NoNoCurrent
84733-302-0484733030204236.58 g in 1 BOTTLE, SPRAY (84733-302-04) 236.58 g2024-10-11NoNoCurrent
84733-302-0884733030208118.29 g in 1 BOTTLE, SPRAY (84733-302-08) 118.29 g2024-10-11NoNoCurrent
84733-302-1684733030216473.17 g in 1 BOTTLE (84733-302-16) 473.17 g2024-10-11NoNoCurrent