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 116 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care MentholMENTHOL 4%Safeway27d3cb47-a6c7-5b7a-e063-6394a90a056f2024-12-05WarningsExact identifier
application number: M017
ITCH XBENZYL ALCOHOL/PRAMOXINE HYDROCHLORIDEBF ASCHER AND CO INC03c16d33-8f59-0184-e054-00144ff8d46c2024-12-05WarningsExact identifier
application number: M017
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
application number: M017
Post Treatment BalmHYDROCORTISONEAllure Labs Inc.faa803e6-453c-4d86-85dd-5a5dcdd72d022024-12-05WarningsExact identifier
application number: M017
CBD Pain Relief CreamTROLAMINE SALICYLATEAllure Labsb6b3102a-4154-2da2-e053-2995a90ae99f2024-12-05WarningsExact identifier
application number: M017
CVS Health Pain RelievingCAMPHOR (SYNTHETIC), MENTHOL (UNSPECIFIED FORM), METHYL SALICYLATENatural Essentials, Inc.f7198485-3d68-41d2-b9b9-f932a06493102024-12-04WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.364924d3-fac3-4f4e-9b40-decd4ec482452024-12-03WarningsExact identifier
application number: M017
Bite and ItchDIPHENHYDRAMINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDEWeeks & Leo Co., Inc.0a4d471b-c3f3-0a6a-e063-6394a90ad57b2024-12-03WarningsExact identifier
application number: M017
MentholAMISH ORIGINS MEDICATEDAmish Origins LLC547abe39-3af3-4d70-99dd-caf8d67feda22024-12-03WarningsExact identifier
application number: M017
ndc (product): 62212-252
Meijer Small Cold-Hot Medicated PatchesMENTHOLMeijer Distribution Incbe6012d6-2062-45ba-8fc4-abf14cff58452024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.acdd5622-a9a7-4cc3-877e-57efea23303f2024-12-03WarningsExact identifier
application number: M017
SalonpasCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu Pharmaceutical Co., Inc.5bb6c6a3-7dc0-463d-ab2c-9f3bd3f3eff52024-12-03WarningsExact identifier
application number: M017
Salonpas DEEP RelievingCAMPHOR, MENTHOL, METHYL SALICYLATEHisamitsu America, Inc.a4ddb2b9-d023-4c8c-9285-93d51f93207d2024-12-03WarningsExact identifier
application number: M017
Salonpas LIDOCAINE PLUSBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEHisamitsu America, Inc.ea5b4a7f-d47d-4dbd-9288-c01329e387e52024-12-03WarningsExact identifier
application number: M017
Hempvana Ultra Strength Pain Relief - OvernightLIDOCAINETelebrands Corp1030d478-6805-6579-e063-6294a90a0c762024-12-02WarningsExact identifier
application number: M017
Campho-Phenique Cold Sore TreatmentCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC106c0bb2-f2e2-4255-867d-d09ff6a5a2e62024-12-02WarningsExact identifier
application number: M017
Campho-Phenique AntisepticCAMPHOR (SYNTHETIC) AND PHENOLFoundation Consumer Healthcare LLC82edaef0-0709-4ae1-a664-c9c5adb91ee12024-12-02WarningsExact identifier
application number: M017
Thermacare Arthritis and Nerve Pain Therapy Capsaicin Roll OnTHERMACARE CAPSAICIN ROLL ONClarion Brands LLC2850f7e7-41dd-f5f9-e063-6394a90ae5192024-12-02WarningsExact identifier
application number: M017
BURNLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDENINGBO TIANBO FIRST AID PRODUCT CO., LTD.2ec1cf79-c341-4b79-9047-ce29f0dff4192024-11-29WarningsExact identifier
application number: M017
TheraCare Pain Relieving Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcare242204d3-efc7-f7a9-e063-6294a90a5af12024-11-27WarningsExact 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