FDA.reportPublic FDA data

Tempo cool

Product NDC
72602-003
11-digit product format
726020003
Labeler code
72602
Product ID
72602-003_5d2db9e7-7898-91cf-e063-6394a90a0dba
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
The Egyptian Saudi Co. For Medical Manufacturing (Masco-Mid) S.A.E
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-20
Substance
MENTHOL; CAMPHOR (NATURAL)
Active strength
3; 1 mg/g; mg/g
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
Tempo cool
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3 mg/g
CAMPHOR (NATURAL)1 mg/g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-12-08TempoCOOL
2021-12-08TempoCOOL
2021-01-29TempoCOOL
2021-01-29TempoCOOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72602-003-01Tempo cool3 g in 1 PATCHPATCH36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72602-003TEMPO COOL (MENTHOL) PATCH [THE EGYPTIAN SAUDI CO. FOR MEDICAL MANUFACTURING (MASCO-MID) S.A.E]5Current NDC, Legacy NDC, 1 package rows20241025_bd642389-6d03-4e09-a71c-312fb90eae89.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 37 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEWALMART STORES INCb82cfe42-f521-4784-8c60-98481524c5ec2026-01-29WarningsExact identifier
application number: M017
Equate Pain Relief Patch Camphor/Menthol/SalicylateCAMPHOR, MENTHOL, METHYL SALICYLATEWalmart Stores Incb869848c-21e2-5ca2-e053-2995a90a86f22026-01-29WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLSUNSET NOVELTIES, INC498cd2aa-ee59-67b5-e063-6294a90ac2422026-01-29WarningsExact identifier
application number: M017
COOLING PAIN RELIEFMENTHOL, CAMPHORSUNSET NOVELTIES, INC498d76d8-788b-4cc7-e063-6294a90a16962026-01-29WarningsExact identifier
application number: M017
MQUPIN Lidocaine Gel-PatchLIDOCAINE GEL-PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49703717-69a6-e480-e063-6394a90ac69c2026-01-28WarningsExact identifier
application number: M017
MQXUNMI LIDOCAINE Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.49706db7-bacd-190f-e063-6394a90a3a8e2026-01-28WarningsExact identifier
application number: M017
Joint and Muscle Relief Topical AnalgesicMENTHOLSmart Cookie Solutions1ecf56b1-ffcb-486f-9fdd-d4dc92aefc1d2026-01-28WarningsExact identifier
application number: M017
VonaFlex Effective Pain Relief Topical AnalgesicLIDOCAINE HYDROCHLORIDEOPTIMAL LABORATORIES, LLC0901244a-7d41-413a-b424-92a807532f282026-01-28WarningsExact identifier
application number: M017
Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEFDynarex960e4240-cd09-2560-e053-2a95a90a7bcf2026-01-28WarningsExact identifier
application number: M017
ALOE ICE SUNBURN RELIEFLIDOCAINE HYDROCHLORIDEAloe Care International, LLC56866fa8-052e-497c-a954-978d7d6289492026-01-28WarningsExact identifier
application number: M017
Walgreens Original Strength Anti ItchDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEWalgreen Companya6a49dbb-74c7-47ca-88f2-3bb3d9acf9142026-01-28WarningsExact identifier
application number: M017
Flobow QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD495b10ce-3d2d-1aa4-e063-6294a90a4f352026-01-27WarningsExact identifier
application number: M017
PAINREUSEABLE PAINShenzhen Mengyue Technology Co., Ltd.44e058fc-e1c0-742b-e063-6294a90ad2252026-01-27WarningsExact identifier
application number: M017
HealthWise Pain Relieving Cream LavenderMENTHOLVeridian Healthcare495eb6e9-69da-f7b6-e063-6294a90accee2026-01-27WarningsExact identifier
application number: M017
HealthWise Pain Relieving CreamMENTHOLVeridian Healthcare49548ab2-267e-1e2a-e063-6394a90ab3912026-01-27WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLWal-Mart Stores, Inc.03feaaef-7401-d464-e063-6294a90a2b2d2026-01-27WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONESTRATEGIC SOURCING SERVICES LLC4a113699-1eb7-49b8-8cdf-2ad57db89b812026-01-27WarningsExact identifier
application number: M017
Healthy Back Institute Rub On ReliefANALGESICFullstack Fulfillment284c29a3-5722-ce70-e063-6394a90a7fa02026-01-26WarningsExact identifier
application number: M017
Velocx for Joint and Muscle Pain Roll-On ApplicatorMENTHOL, METHYL SALICYLATEJMAD Consulting LLC, dba JMAD Labsdbf3eaa3-d85e-46b1-b4a5-a87ba4dc5d212026-01-26WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINMeijer Distribution Inc9b91658f-c15f-4222-bbd9-881b29de3b6e2026-01-26WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72602-003-01726020003013 g in 1 PATCH (72602-003-01) 3 g2018-09-210000-00-00NoNoCurrent