FDA.reportPublic FDA data

NUMOTIZINE

Product NDC
10546-100
11-digit product format
105460100
Labeler code
10546
Product ID
10546-100_082b1721-9122-222f-e063-6294a90a5ea7
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Hobart Laboratories, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-30
Substance
MENTHOL
Active strength
1.25 g/100g
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
NUMOTIZINE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL1.25 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1233196Internal RxNorm lookup
1233201Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a29ad1b-4ba3-403f-90c9-ee7582fe4535Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10546-100-08NUMOTIZINE228 g in 1 JAROINTMENT2288
10546-100-35NUMOTIZINE99 g in 1 JAROINTMENT998

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ANUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
MENTHOLACTIVE MOIETYL7T10EIP3ANUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
CREOSOLINACTIVE INGREDIENTW9GW1KZG6NNUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
GUAIACOLINACTIVE INGREDIENT6JKA7MAH9CNUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
KAOLININACTIVE INGREDIENT24H4NWX5CONUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022YNUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10546-100NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]8Current NDC, Legacy NDC, 2 package rows20231021_9a29ad1b-4ba3-403f-90c9-ee7582fe4535.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 17 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MyDerm Aloe and LidocaineLIDOCAINEMedline Industriesfdfd4388-cd27-467b-959b-249a49ea5cf62026-05-26WarningsExact identifier
application number: M017
MyDerm Aloe and LidocaineLIDOCAINEInspec Solutions LLC.4939c663-a876-4527-822a-df02964fa6942026-05-26WarningsExact identifier
application number: M017
Lidocaine Menthol Pain ReliefLIDOCAINE, MENTHOLAmerisource Bergen94039190-dde3-4d8e-873a-79abd3f6208b2026-05-26WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC858053a0-d888-4bb9-b94e-503bcf3864cb2026-05-21WarningsExact identifier
application number: M017
Arthritis Pain Relief CreamHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.523333ee-eccd-bcf7-e063-6394a90aea602026-05-21WarningsExact identifier
application number: M017
North Star Nutritionals Soothanol X3 Pain Relieving DropsMENTHOLNEWMARKET HEALTH PRODUCTS, LLC068343b8-0435-40d0-846c-9d8624e8b6c42026-05-21WarningsExact identifier
application number: M017
DO ME DELAYLIDOCAINE HCLProdigy Media Inc5255ee85-6f29-0776-e063-6394a90a525b2026-05-21WarningsExact identifier
application number: M017
Australian Dream Back PainHISTAMINE DIHYDROCHLORIDESombra Cosmetics Inc.5256a63e-e6da-84c1-e063-6294a90a8dff2026-05-21WarningsExact identifier
application number: M017
SINSIN HANBANG FLEXCAMPHOR, MENTHOLSinsin Pharmaceutical co., ltd.525c5d18-bfc1-3002-e063-6394a90a5b1d2026-05-21WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEPreferred Pharmaceuticals Inc.6c9a076e-6316-427b-9ce6-c8fe2d3888372026-05-21WarningsExact identifier
application number: M017
Medi-First Capsaicin CreamCAPSAICINUnifirst First Aid Corporation49eb807b-fa31-3d84-e063-6394a90acfcf2026-05-20WarningsExact identifier
application number: M017
Biofreeze Triple Target Roll-OnCAMPHOR, CAPSAICIN, MENTHOLReckitt Benckiser LLC5089c088-3026-233a-e063-6394a90a93b62026-05-19WarningsExact identifier
application number: M017
Lidocaine Pain Relief PatchLIDOCAINEGERI-CARE PHARMACEUTICAL CORP522f1521-f9f2-4c26-e063-6394a90a9e052026-05-19WarningsExact identifier
application number: M017
Easment 0.1% Capsaicin Roll onCAPSAICIN 0.1%Easment LLC521212d6-57fd-4a7a-e063-6294a90a2a182026-05-18WarningsExact identifier
application number: M017
Burn ReliefLIDOCAINEWALMART INC.15af4557-4baf-c177-e063-6294a90a7a5b2026-05-18WarningsExact identifier
application number: M017
Blistex Maximum Hydration LipCAMPHOR (SYNTHETIC), DIMETHICONE, UNSPECIFIED, MENTHOL, UNSPECIFIED FORM, AND PHENOLBlistex Inc.fed223bc-edf3-46eb-b678-acb906f9ef112026-05-18WarningsExact identifier
application number: M017
Tiger BalmCAMPHOR (SYNTHETIC), MENTHOL, AND CAPSICUMHaw Par Healthcare Ltd.5066dc10-e4d5-49e9-9a5f-0ac220cfbf282026-05-18WarningsExact identifier
application number: M017
Deep Blue MiniMENTHOLdoTERRA International, LLC51dd58a8-1fd5-9cd7-e063-6394a90a1f722026-05-15WarningsExact identifier
application number: M017
Biofreeze Overnight GelMENTHOLReckitt Benckiser LLCf5c8c08b-c7c0-f84d-e053-2a95a90add152026-05-15WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMReckitt Benckiser LLC00bba5d2-b0e0-701c-e063-6294a90a57412026-05-15WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1233196menthol 1.25 % Topical OintmentPSN9a29ad1b-4ba3-403f-90c9-ee7582fe45358
1233201NUMOTIZINE 1.25 % Topical OintmentPSN9a29ad1b-4ba3-403f-90c9-ee7582fe45358
1233201menthol 0.0125 MG/MG Topical Ointment [Numotizine]SBD9a29ad1b-4ba3-403f-90c9-ee7582fe45358
1233196menthol 0.0125 MG/MG Topical OintmentSCD9a29ad1b-4ba3-403f-90c9-ee7582fe45358
1233201Numotizine 0.0125 MG/MG Topical OintmentSY9a29ad1b-4ba3-403f-90c9-ee7582fe45358
1233201Numotizine 1.25 % Topical OintmentSY9a29ad1b-4ba3-403f-90c9-ee7582fe45358

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10546-100-0810546010008228 g in 1 JAR (10546-100-08) 228 g2011-11-300000-00-00NoNoCurrent
10546-100-351054601003599 g in 1 JAR (10546-100-35) 99 g2011-11-300000-00-00NoNoCurrent