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 5 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RELIBONEOintmentTOPICAL ANALGESICOINTMENTGuangdong Jiaoyu Biotechnology Co., Ltd58ddaaf6-18ec-8c5b-e063-6294a90a28282026-08-12WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58de3a29-2bec-6e44-e063-6394a90a9c1a2026-08-12WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEAmazon.com Services LLCf40b4223-e81f-4cd0-bc9b-d3d33ce8cce52026-08-12WarningsExact identifier
application number: M017
Muscle Rub CreamMUSCLE RUBALLIED TRADE LINK LLC11d33e60-8c64-4316-a29a-d17e3e6e4a282026-08-11WarningsExact identifier
application number: M017
Gee GasonMALE GENITAL DESENSITIZERMon Gars Boutique Inc58c75e5c-b801-017f-e063-6394a90a1c752026-08-11WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINTrifecta Pharmaceuticals USA LLC58c84330-15bf-c397-e063-6394a90aba052026-08-11WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONETARGET Corporation4a140b9a-0e3c-4b50-b9c0-9e72616bb7d52026-08-11WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy0e988da1-1904-431d-a152-bdb2aacc8e162026-08-11WarningsExact identifier
application number: M017
Medicated BODYMENTHOLCVS Pharmacy, Inc.a0f61498-69c8-4ce0-bbd7-3a807f192d362026-08-11WarningsExact identifier
application number: M017
Muscle MoveMENTHOLSaje Natural Wellness Inc.526d3305-4cf8-2fc5-e063-6394a90ad53b2026-08-10WarningsExact identifier
application number: M017
Relieve and Relax Pain RelievingCAMPHOR (SYNTHETIC), MENTHOLMAC Innovations, LLCc0528c36-d322-8110-e053-2995a90add6c2026-08-08WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOLCVS Pharmacy4aa629f5-8b8f-cc67-e063-6394a90a019f2026-08-07WarningsExact identifier
application number: M017
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
application number: M017
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE, ZINC ACETATECVS Pharmacy46921bea-fcbe-94d6-e063-6394a90a726b2026-08-07WarningsExact identifier
application number: M017
CVS Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Pharmacy524605f9-8b04-b600-e063-6394a90a4a022026-08-07WarningsExact identifier
application number: M017
LidonexLIDOCAINE HCL, MENTHOLAldama Pharmaceuticals, Inc365cf19c-70e0-c4e9-e063-6294a90ac4282026-08-07WarningsExact identifier
application number: M017
Blaster Pain Relief StickMENTHOL, METHYL SALICYLATE, CAMPHORKalahari Rose, LLC587d660a-5f80-de5a-e063-6394a90aa2872026-08-07WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATECardinal Health, 110 dba Leader3ed7b8a1-012f-459d-878c-813b93d4673c2026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Gel Cooling Pain ReliefMENTHOLThe Kroger Co.6fb0acc8-8dab-452c-b09e-de97306e1c322026-08-06Warnings, Adverse reactionsExact identifier
application number: M017
Lidocaine Tattoo WipeLIDOCAINE HYDROCHLORIDEMD Tattoo Company369c1d16-597c-e1dc-e063-6394a90a31042026-08-06WarningsExact 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