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 151 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COOL BREEZE Pain ReliefMENTHOLCOOL BREEZE US LLC14dcf4ee-6778-49d4-8601-9205737432ea2023-11-01WarningsExact identifier
application number: M017
LidozenLIDOCAINE HYDROCHLORIDE, MENTHOLProficient Rx LP1ebb45e5-4541-4c95-abe1-661ef763a6102023-11-01WarningsExact identifier
application number: M017
Walgreens Pain Relieving CreamLIDOCAINE 4%Walgreensce1b55ed-f5c5-ea8b-e053-2a95a90acd402023-10-31WarningsExact identifier
application number: M017
Walgreens pain relievingLIDOCAINE 4%Walgreensce2b9e57-749d-715c-e053-2995a90aaf8d2023-10-31WarningsExact identifier
application number: M017
Walgreens Cool n heatLIDOCAINE 4% MENTHOL 1%Walgreensce168ab7-ec4a-daea-e053-2995a90af8292023-10-31WarningsExact identifier
application number: M017
Methyl Salicylate 40 PercentMETHYL SALICYLATEAlexso, Inc53407aab-094c-4393-a2b9-54fd85321e3e2023-10-31WarningsExact identifier
application number: M017
Hydrocortisone AcetateHYDROCORTISONE ACETATEBentlin Products LLC4346351c-8e11-46ae-b428-98d17f55beb92023-10-30WarningsExact identifier
application number: M017
Biofreeze Roll-OnMENTHOLA-S Medication Solutions814b37ea-5441-4cec-8794-71ca01d849ae2023-10-30WarningsExact identifier
application number: M017
Dr. Sheffield Hydrocortisone Anti itchHYDROCORTISONESheffield Pharmaceuticals LLC71c9f2f4-2188-45eb-b55e-3856ac78070b2023-10-30WarningsExact identifier
application number: M017
Family WellnessBENZOCAINE, RESORCINOLZhejiang Jingwei Pharmaceutic Al Co., Ltd.df540eb8-6773-4647-9cc2-c3fd14d7355e2023-10-27WarningsExact identifier
application number: M017
Family WellnessHYDROCORTISONE 1%FRONT PHARMACEUTICAL PLCea26265d-f24e-458e-8bf0-287b2d49f4f42023-10-27WarningsExact identifier
application number: M017
Joint Formula 88 MAX PLUSCAMPHORSarati International, Inc.f5d78335-b78d-4909-a88b-9daa3c18ba152023-10-27WarningsExact identifier
application number: M017
OsmoFlexMENTHOLSarati International, Inc.479147c0-4cf4-4d7a-8b8e-1a0de49ed73e2023-10-27WarningsExact identifier
application number: M017
Thera plus Anti-itch with aloe HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc.c69d0670-a65b-1680-e053-2995a90a2ee52023-10-26WarningsExact identifier
application number: M017
Family WellnessDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEFRONT PHARMACEUTICAL PLCfde2069b-344e-46da-bb95-c5113e0f35d62023-10-26WarningsExact identifier
application number: M017
MAXIMUM STRENGTH HEMORRHOIDAL RELIEFLIDOCAINECVS PHARMACY, INCb61424bf-3b23-420b-a7bc-256ddb96aa222023-10-25WarningsExact identifier
application number: M017
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOL, UNSPECIFIED FORMTroy Manufacturing, Inc.b41091b4-0dc0-4a88-8ff6-11979b3d307a2023-10-25WarningsExact identifier
application number: M017
Thera PlusHYDROCORTISONEZhejiang Jingwei Pharmaceutical Co., Ltd.bcc99e5a-2403-46da-9c9d-8411fa4104e02023-10-25WarningsExact identifier
application number: M017
AssuredLIDOCAINE HYDROCHLORIDEZhejiang Jingwei Pharmaceutical Co., Ltd.ab25c47d-bbe6-4e2b-9e39-dd9f4da3ee8c2023-10-25WarningsExact 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