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
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
2adf3c4d-636f-4e02-b501-946b4df5f5d6Available 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

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

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 21 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
New TerocinMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLASCLEMED USA INC.68dc0231-3364-448b-bde9-f19fa122c7652026-05-05WarningsExact identifier
application number: M017
Lidocaine 4% PatchLIDOCAINE 4%SOLA Pharmaceuticalsc31957dd-edea-ce98-e053-2a95a90a9c2d2026-05-05WarningsExact identifier
application number: M017
Biofreeze Triple Target GelCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC511852c8-7428-3234-e063-6394a90a5bc22026-05-05WarningsExact identifier
application number: M017
5Kind DMSO Pain RelievingCAMPHOR (SYNTHETIC)5Kind Trading LTD62b55114-47f4-473a-8406-78238c3c1fa22026-05-04WarningsExact identifier
application number: M017
Zinc Oxide with Menthol and White PetrolatumMENTHOL, ZINC OXIDE, WHITE PETROLATUMAldermed Inc.f993fc0a-bd80-4345-a948-65ac03f910e22026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDEEVERLIT GLOBAL INC.d7ec5720-4d1f-4943-ae36-c7d6acbae7d72026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE PRODUCTS BURN RELIEFLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.5371dae4-ea63-46cc-ac26-5418f359c63e2026-05-04WarningsExact identifier
application number: M017
EVERLIT CARE BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.a2cf1726-3dc9-4624-b898-ac91fb4cbdb22026-05-04WarningsExact identifier
application number: M017
FIRSTAR BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.186343c5-2e71-49c4-8d64-5fb3131239fa2026-05-04WarningsExact identifier
application number: M017
Feminine Anti Itch CreamBENZOCAINE,RESORCINOLTRIFECTA PHARMACEUTICALS USA LLC50c3acbf-b873-908a-e063-6294a90a66b72026-05-01WarningsExact identifier
application number: M017
24 7 Relief and Recovery Pain RelievingMENTHOL, UNSPECIFIED FORMTriplicare Inc53ca807b-3ec2-4b5e-aa5a-6dcb756bb4232026-04-30WarningsExact identifier
application number: M017
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE4 Visions LLC50b1351d-72dd-e0c9-e063-6294a90ac7432026-04-30WarningsExact identifier
application number: M017
TheraCare Flexible Pain RelievingLIDOCAINEVeridian Healthcare4f108002-2cae-0671-e063-6294a90ab6cf2026-04-30WarningsExact identifier
application number: M017
Pain Relief Gel Roll OnMENTHOLTrifecta Pharmaceuticals USA50b1a420-d5cd-6d61-e063-6294a90a04512026-04-30WarningsExact identifier
application number: M017
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEPadagis Israel Pharmaceuticals Ltd2dc7f76f-f9ad-46ba-8b41-952e1c15f0522026-04-29WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEHyVee Ince1db3641-2e83-4fec-8394-98d0d876ce0d2026-04-29WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll OnMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA50805eee-33b3-86bd-e063-6294a90a77d82026-04-28WarningsExact identifier
application number: M017
FixMySkin Healing Balm Vanilla FlavorHYDROCORTISONELovely Skin, Inc.52f7a561-a0b5-4562-a588-d74fd874b83a2026-04-28WarningsExact identifier
application number: M017
Blue Star MedicatedCAMPHORFocus Consumer Healthcare, LLC56df008e-a23b-4870-e054-00144ff8d46c2026-04-27WarningsExact 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

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