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 74 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Medicine Infused SocksCAPSAICINNufabrx LLC00d7d5bf-ee03-e73d-e063-6394a90a5d942025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Elbow SleeveCAPSAICINNufabrx LLC27ef3ef0-2f98-6672-e063-6294a90aeca42025-10-15WarningsExact identifier
application number: M017
Nufabrx Medicine Infused Wrist SleeveCAPSAICINNufabrx LLC22572cf9-fc0c-d327-e063-6394a90a21862025-10-15WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWALGREENSeff77965-dc7f-49af-e053-2995a90a1a972025-10-14WarningsExact identifier
application number: M017
Pleasure Balm Kama SutraBENZOCAINECosmetic Enterprises Ltdf370e3c4-65ca-4f3c-a5aa-70e198e681a22025-10-14WarningsExact identifier
application number: M017
Vanicream HC Anti-ItchHYDROCORTISONEPharmaceutical Specialties, Inc.28b06507-27a5-2cb1-e054-00144ff8d46c2025-10-14WarningsExact identifier
application number: M017
TrilogelLIDOCAINE HYDROCHLORIDETrifluent Pharma LLC22af7d63-6a56-4a38-a95b-0f88410b23cb2025-10-14WarningsExact identifier
application number: M017
PROINNATE Numbing CreamMENTHOLGuangzhou Haishi Biological Technology Co., Ltd.40c63645-8ed3-82b3-e063-6294a90a52672025-10-13WarningsExact identifier
application number: M017
CramergesicMENTHOL, METHYL SALICYLATEThe Hygenic Company, LLCd0ffde7a-6942-74fc-e053-2a95a90a484a2025-10-13WarningsExact identifier
application number: M017
TricylateMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATETrifluent Pharma LLC4869b63a-e01e-4a79-a493-7a1b4d3e914b2025-10-13WarningsExact identifier
application number: M017
Doloflex Pain ReliefMENTHOL, METHYL SALICYLATEUnited Health & Beauty Corp32a830cc-04d3-102e-e063-6294a90a1cad2025-10-12WarningsExact identifier
application number: M017
Lidocaine Pain Relieving Gel-PatchLIDOCAINENanjing Anxing Medical Technology Co., Ltd.40c9b132-57ce-865e-e063-6394a90a20802025-10-10WarningsExact identifier
application number: M017
KinesysZINC OXIDEWilc Healthcare Inca32b44c3-eda0-48ea-95fc-250a2c2396ca2025-10-10WarningsExact identifier
application number: M017
Te-Fu Recovery MassageMENTHOL, METHYL SALICYLATEWasatch Product Development7bc2989f-dfb6-e8af-e053-2991aa0a0bf22025-10-10WarningsExact identifier
application number: M017
Anti-itchHYDROCORTISONEMedline Industries, LPb0947381-c0db-4253-ab40-3d45603ae65d2025-10-09WarningsExact identifier
application number: M017
Kalaya Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe2452c4b-2548-497f-828b-5d960402522a2025-10-08WarningsExact identifier
application number: M017
Kalaya Pain Relief 6X with ArnicaPAIN RELIEF CREAMAvaria Health & Beauty Corp60198d2e-4de3-3fa0-e053-2a91aa0afaf72025-10-08WarningsExact identifier
application number: M017
KALAYA PAIN RELIEF 6X WITH ARNICA - Pain ReliefMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corp9b9b7cad-a5e2-4445-856b-4aa439d77a802025-10-08WarningsExact identifier
application number: M017
KALAYA FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpd5021e6d-f29f-446b-874c-bdcabd9cf4f62025-10-08WarningsExact identifier
application number: M017
KALAYA EXTRA STRENGTH FOAMING PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAMPHORAvaria Health & Beauty Corpe0c9f22a-165a-4558-ba3c-8592f1bd00162025-10-08WarningsExact 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