FDA.reportPublic FDA data

Pain Release

Product NDC
70983-005
11-digit product format
709830005
Labeler code
70983
Product ID
70983-005_48511a10-f9ec-bee8-e063-6394a90a913f
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
2.23 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
Pain Release
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.23 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a32b0950-3467-4e37-988d-104836af5971Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-005-08Pain Release1 in 1 BOXLIQUID15
70983-005-08Pain Release100 mL in 1 BOTTLE, SPRAYLIQUID1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-005PAIN RELEASE (MENTHOL) LIQUID [SAJE NATURAL BUSINESS INC.]4Current NDC, Legacy NDC, 2 package rows20231006_a32b0950-3467-4e37-988d-104836af5971.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70983-005-08709830005081 BOTTLE, SPRAY in 1 BOX (70983-005-08) / 100 mL in 1 BOTTLE, SPRAY2016-10-160000-00-00NoNoCurrent