FDA.reportPublic FDA data

AY BENDITO - THERMOACTIVE

Product NDC
72524-641
11-digit product format
725240641
Labeler code
72524
Product ID
72524-641_32c5f87f-17cb-c554-e063-6394a90a1257
Type
HUMAN OTC DRUG
Nonproprietary name
CAMPHOR, MENTHOL
Dosage form
CREAM
Route
TOPICAL
Labeler
AY BENDITO INTERNATIONAL, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-22
Substance
CAMPHOR (NATURAL); MENTHOL, (+)-
Active strength
6; 4 g/100g; g/100g
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
AY BENDITO - THERMOACTIVE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (NATURAL)6 g/100g
MENTHOL, (+)-4 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N20HL7Q941Internal UNII lookup
C6B1OE8P3WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2610198Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bbf0d85e-269d-0342-e053-2995a90ac63cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72524-641-04AY BENDITO - THERMOACTIVE113 g in 1 TUBECREAM1139

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72524-641AY BENDITO - THERMOACTIVE (CAMPHOR, MENTHOL) CREAM [AY BENDITO INTERNATIONAL, INC]9Current NDC, Legacy NDC, 1 package rows20250416_bbf0d85e-269d-0342-e053-2995a90ac63c.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 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bactine Max Antibiotic and Lidocaine Max Pain ReliefLIDOCAINEWellSpring Pharmaceutical Corporation71300df9-6113-4f25-93ca-28ad7e7f79de2023-06-08WarningsExact identifier
application number: M017
Bactine Max Lidocaine Roll-on 2.5ozLIDOCAINEWellSpring Pharmaceutical Corporation09b32a98-9131-451e-87a6-81a1e4ed7ec52023-04-25WarningsExact identifier
application number: M017
Icy Hot Pro DryCAMPHOR, MENTHOLChattem, Inc.4de1bc29-d166-4599-9e75-5f841bf209672023-03-01WarningsExact identifier
application number: M017
Icy Hot Vanishing ScentMENTHOLChattem, Inc.e2092016-9741-433d-92e6-74bfddadb72c2022-09-29WarningsExact identifier
application number: M017
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLAlexso, Inc5dbd5fc0-a27e-4979-aca7-28f73096fd5f2022-08-18WarningsExact identifier
application number: M017
FIRSTAR Sting Relief PadBENZOCAINEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.0e491a7a-4204-439f-862d-741cbc0be9fd2021-07-06WarningsExact identifier
application number: M017
Arthritis Relief GoodSenseTROLAMINE SALICYLATEGeiss, Destin & Dunn, Inca253730a-2187-07de-e053-2a95a90a98772020-04-02WarningsExact identifier
application number: M017
Aloe CortHYDROCORTISONETopiderm, Inc.789a6669-3320-4558-8d6f-ab255db50d8d2019-09-17WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited567b6820-fb52-630e-e063-6294a90a8bf82015-07-01WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited54e45d89-e8c3-6fc3-e063-6394a90aac4e2015-06-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2610198camphor 6 % / menthol 4 % Topical CreamPSNbbf0d85e-269d-0342-e053-2995a90ac63c9
2610198camphor 60 MG/ML / menthol 40 MG/ML Topical CreamSCDbbf0d85e-269d-0342-e053-2995a90ac63c9
2610198camphor 6 % / menthol 4 % Topical CreamSYbbf0d85e-269d-0342-e053-2995a90ac63c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72524-641-0472524064104113 g in 1 TUBE (72524-641-04) 113 g2021-01-220000-00-00NoNoCurrent