FDA.reportPublic FDA data

Menthol

Product NDC
62212-252
11-digit product format
622120252
Labeler code
62212
Product ID
62212-252_28656961-9c32-9983-e063-6394a90ae6e4
Type
HUMAN OTC DRUG
Nonproprietary name
Amish Origins Medicated
Dosage form
CREAM
Route
TOPICAL
Labeler
Amish Origins LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-01
Substance
MENTHOL
Active strength
8 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL8 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727161Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
547abe39-3af3-4d70-99dd-caf8d67feda2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62212-252-01Menthol99.22 g in 1 BOTTLECREAM99.2226
62212-252-02Menthol99.22 g in 1 BOTTLE, PUMPCREAM99.2226
62212-252-03Menthol400 g in 1 BOTTLECREAM40026
62212-252-04Menthol198.45 g in 1 BOTTLE, PUMPCREAM198.4526

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
MENTHOLACTIVE MOIETYL7T10EIP3AMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
ABIES SIBIRICA LEAF OILINACTIVE INGREDIENTXRY0V4VZKZMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)INACTIVE INGREDIENTV2W71V8T0XMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
CHLORPHENESININACTIVE INGREDIENTI670DAL4SZMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
CINNAMOMUM CAMPHORA WHOLEINACTIVE INGREDIENT0B27814T7XMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
EUCALYPTUS GLOBULUS LEAFINACTIVE INGREDIENTS546YLW6E6MENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
SUNFLOWER SEED OIL GLYCERETH-8 ESTERSINACTIVE INGREDIENT358X17CAT0MENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5
WATERINACTIVE INGREDIENT059QF0KO0RMENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62212-252MENTHOL (AMISH ORIGINS MEDICATED) CREAM [AMISH ORIGINS LLC]26Current NDC, Legacy NDC, 4 package rows20241207_547abe39-3af3-4d70-99dd-caf8d67feda2.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 22 of 156 · 3,115 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEBorden Company (Private) Limited06cb845c-cc53-1f1d-e063-6394a90a8c012026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA0ef7c3aa-94a3-9fe9-e063-6394a90ab13d2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated OilMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5071f145-49f7-0855-e063-6394a90a8f262026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09260c31-56a3-07aa-e063-6394a90a95fd2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Muscle RubMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMA5072ad57-9fa7-ddba-e063-6394a90a319b2026-04-27WarningsExact identifier
application number: M017
Eagle Brand Medicated Roll On RefreshCAMPHOR, MENTHOLPT. EAGLE INDO PHARMA09235f26-2262-6ca2-e063-6394a90ad8f12026-04-27WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727161menthol 8 % Topical CreamPSN547abe39-3af3-4d70-99dd-caf8d67feda226
727161menthol 80 MG/ML Topical CreamSCD547abe39-3af3-4d70-99dd-caf8d67feda226
727161menthol 8 % Topical CreamSY547abe39-3af3-4d70-99dd-caf8d67feda226

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62212-252-016221202520199.22 g in 1 BOTTLE (62212-252-01) 99.22 g2013-01-010000-00-00NoNoCurrent
62212-252-026221202520299.22 g in 1 BOTTLE, PUMP (62212-252-02) 99.22 g2013-01-01NoNoCurrent
62212-252-0362212025203400 g in 1 BOTTLE (62212-252-03) 400 g2013-01-01NoNoCurrent
62212-252-0462212025204198.45 g in 1 BOTTLE, PUMP (62212-252-04) 198.45 g2013-01-01NoNoCurrent