FDA.reportPublic FDA data

AY BENDITO THERMOACTIVE

Product NDC
72524-046
11-digit product format
725240046
Labeler code
72524
Product ID
72524-046_304d71b6-91c9-b2b6-e063-6394a90ab669
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL, CAMPHOR
Dosage form
SPRAY
Route
TOPICAL
Labeler
AY BENDITO INTERNATIONAL, INC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-28
Substance
CAMPHOR (SYNTHETIC); MENTHOL
Active strength
5.3; 3.6 g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AY BENDITO THERMOACTIVE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)5.3 g/100mL
MENTHOL3.6 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5TJD82A1ET, L7T10EIP3A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72524-046-02AY BENDITO THERMOACTIVE59 mL in 1 BOTTLE, SPRAYSPRAY591
72524-046-04AY BENDITO THERMOACTIVE118 mL in 1 BOTTLE, SPRAYSPRAY1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72524-046AY BENDITO THERMOACTIVE (MENTHOL, CAMPHOR) SPRAY [AY BENDITO INTERNATIONAL, INC]1Current NDC, 2 package rows20250328_304d71b6-91c8-b2b6-e063-6394a90ab669.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72524-046-027252400460259 mL in 1 BOTTLE, SPRAY (72524-046-02) 59 ml2025-03-28NoNoHistorical
72524-046-0472524004604118 mL in 1 BOTTLE, SPRAY (72524-046-04) 118 ml2025-03-28NoNoHistorical