FDA.reportPublic FDA data

Pain Release

Product NDC
70983-010
11-digit product format
709830010
Labeler code
70983
Product ID
70983-010_48514309-b4d2-69e9-e063-6294a90afe9e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
KIT
Labeler
Saje Natural Business Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
481a493b-0620-46ac-8228-e9964b7eb24bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70983-010-12Pain Release1 in 1 KITKIT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70983-010PAIN RELEASE (MENTHOL) KIT [SAJE NATURAL BUSINESS INC.]4Current NDC, Legacy NDC, 1 package rows20231007_481a493b-0620-46ac-8228-e9964b7eb24b.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 76 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLC66b13044-69d2-4559-9e65-8a4c601c077a2025-10-06WarningsExact identifier
application number: M017
Methyl SalicylateMETHYL SALICYLATEPHARMACURE LLCf119a1bd-095f-41f5-86d5-c0ee4f19fd2c2025-10-06WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINEPHARMACURE LLC31d5e5c9-6ec4-4496-8a4c-cca39a2cbe322025-10-06WarningsExact identifier
application number: M017
Tempo coolMENTHOLThe Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.Ebd642389-6d03-4e09-a71c-312fb90eae892025-10-06WarningsExact identifier
application number: M017
Menthopatch HotMENTHOL , CAPSICUM EXTRACTTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID3d289be3-c237-4065-a8ac-e8c2e51b76a52025-10-06WarningsExact identifier
application number: M017
Mentho patch coolMENTHOLTHE EGYPTIAN SAUDI CO FOR MEDICAL MANUFACTURING MASCOMID02251a4a-fc6f-42c9-a244-6f4835de5edd2025-10-06WarningsExact identifier
application number: M017
Feminine Anti-Itch CremeBENZOCAINE, RESORCINOLQuality Choice (CHAIN DRUG MARKETING ASSOCIATION)aa6cc963-dc60-5222-e053-2995a90acaf62025-10-06WarningsExact identifier
application number: M017
TheraCare 2% Diphenhydramine Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATEVeridian Healthcare5999b677-63dd-49c6-b5b8-7b3c117ecc5c2025-10-06WarningsExact identifier
application number: M017
HealthWise Pain ReliefMENTHOLVeridian Healthcare06be5331-7a1e-4ab3-9f17-2d350bd4b8902025-10-02WarningsExact identifier
application number: M017
equate Burn ReliefLIDOCAINE HYDROCHLORIDEWalmart Inca90cbd92-80a5-4463-8152-b83165121a6f2025-10-02WarningsExact identifier
application number: M017
AsperFlex HOTCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.a6cb0656-8866-44ff-b40c-73655ff687212025-10-02WarningsExact identifier
application number: M017
AsperFlex Original Maximum StrengthMENTHOLAkron Pharma Inc.d766c61e-c48b-4aff-97b0-678159479e032025-10-02WarningsExact identifier
application number: M017
HealthWise Feminine Anti-Itch CreamBENZOCAINE, RESORCINOLVeridian Healthcare1f9110da-f448-8e20-e063-6294a90a42752025-10-02WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCdc704403-e2aa-47f7-a7f4-f6afe1547ca82025-10-01WarningsExact identifier
application number: M017
PROSTAT FIRST AID Burn Ease, 0.9gLIDOCAINEProStat First Aid LLCe02558a9-fe2b-4f28-9fd3-7308f859d7592025-10-01WarningsExact identifier
application number: M017
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
application number: M017
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
application number: M017
Viaderma Calm Anti-ItchHYDROCORTISONEViaDerma Distribution, Inc.7afa2ccd-bfc6-48fc-9a14-a0c6d645844e2025-10-01WarningsExact identifier
application number: M017
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC4024d604-c8c7-2d73-e063-6294a90a2e802025-10-01WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70983-010-12709830010121 KIT in 1 KIT (70983-010-12) * 10 mL in 1 BOTTLE, DROPPER * 40 mL in 1 BOTTLE, DROPPER * 30 mL in 1 BOTTLE, SPRAY * 1 POUCH in 1 PACKAGE / 120 g in 1 POUCH1 kit2016-10-160000-00-00NoNoCurrent