FDA.reportPublic FDA data

Menthozen

Product NDC
71205-153
11-digit product format
712050153
Labeler code
71205
Product ID
71205-153_f17baf72-5a83-4b63-9ec3-2a3fb64bdd0e
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Proficient Rx LP
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
CAPSAICIN; MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength
.375; 50; 200 mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Menthozen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE.375 mg/mL
MENTHOL, UNSPECIFIED FORM50 mg/mL
CAPSAICIN200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLAV5U5022Y, L7T10EIP3A, S07O44R1ZM
Rxcui1099896

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-153-72Menthozen120 mL in 1 BOTTLECREAM1206
71205-153-72Menthozen1 in 1 BOXCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-153-72ML - Milliliter71205-15318f0e483-7e92-4104-97d6-9f030a975d4712019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-153MENTHOZEN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [PROFICIENT RX LP]6Current NDC, Legacy NDC, 2 package rows20231207_2adf3c4d-636f-4e02-b501-946b4df5f5d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099896methyl salicylate 20 % / menthol 5 % / capsaicin 0.0375 % Topical CreamPSN2adf3c4d-636f-4e02-b501-946b4df5f5d66
1099896capsaicin 0.375 MG/ML / menthol 50 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCD2adf3c4d-636f-4e02-b501-946b4df5f5d66
1099896capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical CreamSY2adf3c4d-636f-4e02-b501-946b4df5f5d66

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-153-72712050153721 BOTTLE in 1 BOX (71205-153-72) / 120 mL in 1 BOTTLE1 bottle2018-11-010000-00-00NoNoCurrent