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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLAmazon.com Services LLCadb638ec-4a7c-42f2-b249-0ac53a8dd4b22026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact 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