FDA.reportPublic FDA data

Menthozen

Product NDC
71574-600
11-digit product format
715740600
Labeler code
71574
Product ID
71574-600_49124ae3-42ed-4a76-a091-ac46529ed235
Type
HUMAN OTC DRUG
Nonproprietary name
METHYL SALICYLATE, MENTHOL, CAPSAICIN
Dosage form
CREAM
Route
TOPICAL
Labeler
Village Pharma LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-10-01
Substance
METHYL SALICYLATE; MENTHOL, UNSPECIFIED FORM; CAPSAICIN
Active strength
200; 50; .375 mg/mL; mg/mL; mg/mL
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
Menthozen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHYL SALICYLATE200 mg/mL
MENTHOL, UNSPECIFIED FORM50 mg/mL
CAPSAICIN.375 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LAV5U5022YInternal UNII lookup
L7T10EIP3AInternal UNII lookup
S07O44R1ZMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1099896Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13Available on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71574-600-722021-10-21C16284748780-1ba0f9c33-19a0-a910-e053-dadaa90a0b85Menthozen Cream
71574-600-722021-01-29C16284748780-1ba0f9c33-19a0-a910-e053-dadaa90a0b85Menthozen Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71574-600-72Menthozen1 in 1 BOXCREAM14
71574-600-72Menthozen120 mL in 1 BOTTLECREAM1204

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71574-600-72ML - Milliliter71574-6000baa4962-4d7a-46b4-99cd-305ff66f507212019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71574-600MENTHOZEN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [VILLAGE PHARMA LLC]3Current NDC, Legacy NDC, 2 package rows20231201_48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13.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 47 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLJC SALES490bc3b1-48bf-5437-e063-6394a90a90182026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.5ae00308-0a8c-065c-e063-6394a90aff6b2026-01-01WarningsExact identifier
application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.4a24e813-6dbc-3fd1-e063-6294a90a4ff02026-01-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLVillage Pharma LLCd0ec7d25-ad58-46f2-b3b3-f13b4648b0b62026-01-01WarningsExact identifier
application number: M017
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLFSA Store Inc.47434af6-0fdd-9615-e063-6394a90ab9e82025-12-31WarningsExact identifier
application number: M017
Winco Lidocaine Pain Patch 4% 5ctLIDOCAINE PAIN PATCH 4%WINCO FOODS, LLC47439162-fc34-f0d0-e063-6394a90a29ab2025-12-31WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHQUEST USA CORP.1ad47834-4f8e-c692-e063-6294a90a7e772025-12-31WarningsExact identifier
application number: M017
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
application number: M017
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub LavenderCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company47473b24-a3e3-2858-e063-6394a90a59202025-12-31WarningsExact identifier
application number: M017
Eucerin Itch Relief Intensive CalmingMENTHOLBeiersdorf Inca7a78af1-1f5a-684d-e053-2a95a90a6ae92025-12-31WarningsExact identifier
application number: M017
Eucerin Skin Calming Itch Relief TreatmentMENTHOLBeiersdorf Inc7e568311-1e6b-9b4b-e053-2991aa0a7b672025-12-31WarningsExact identifier
application number: M017
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsExact identifier
application number: M017
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
application number: M017
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsExact identifier
application number: M017
Kroger Hot and Cold Medicated PatchMENTHOLKroger Company0331c1dd-fe30-421a-85a7-6c6886e7ab272025-12-30WarningsExact identifier
application number: M017
Menthol, CamphorMENTHOL, CAMPHORChemco Corporation472fb097-92e5-c230-e063-6294a90ab33a2025-12-30WarningsExact identifier
application number: M017
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact identifier
application number: M017

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
1099896methyl salicylate 20 % / menthol 5 % / capsaicin 0.0375 % Topical CreamPSN48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb134
1099896capsaicin 0.375 MG/ML / menthol 50 MG/ML / methyl salicylate 200 MG/ML Topical CreamSCD48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb134
1099896capsaicin 0.0375 % / menthol 5 % / methyl salicylate 20 % Topical CreamSY48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71574-600-72715740600721 BOTTLE in 1 BOX (71574-600-72) / 120 mL in 1 BOTTLE1 bottle2018-10-010000-00-00NoNoCurrent