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 103 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IKONIK TONIKLIDOCAINE HYDROCHLORIDEIKONIK CARE, LLC122fdfe8-b5fa-46d1-9fd9-3df9887ed3202025-01-14WarningsExact identifier
application number: M017
elp essential MANTECA DE UBREMETHYL SALICYLATE, CAMPHORMiramar Cosmetics, Inc DBA Miramar Labc3964dfe-17fe-4d89-a4c4-cf500f9822592025-01-13WarningsExact identifier
application number: M017
MethyltenMETHYL SALICYLATE 10%Puretek Corporation28f4093f-803f-0e70-e063-6294a90a98a42025-01-13WarningsExact identifier
application number: M017
Refill Bundle 7 Large OfficeBENZALKONIUM CHLORIDECMC Group, Inc.6620a8f3-098d-d045-e053-2a91aa0a0d942025-01-13WarningsExact identifier
application number: M017
Jakwork Numbing CreamNUMBING CREAMGuangzhou Zanming Trading Co., Ltd.2ba1de83-494a-6c54-e063-6294a90a9b2d2025-01-13WarningsExact identifier
application number: M017
Arthritis HotMENTHOL AND METHYL SALICYLATEChattem, Inc.cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd2025-01-13WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b40dda-53ad-0458-e063-6394a90aa8352025-01-11WarningsExact identifier
application number: M017
Re-Lieved Lidocaine PatchLIDOCAINE PATCH 4%Transfer Technology00b47eb7-6b43-d9e2-e063-6294a90a9a382025-01-11WarningsExact identifier
application number: M017
Re-Lieved 4% Lidocaine Fabric TapeLIDOCAINE 4% FABRIC TAPETransfer Technologye9a894b0-54f2-707e-e053-2a95a90a0f0d2025-01-11WarningsExact identifier
application number: M017
Re-Lieved 3 in 1 PatchMENTHOL, CAMPHOR, METHYL SALICYLATE PATCHTransfer Technologye9ab9a03-b9e3-7317-e053-2995a90a99502025-01-11WarningsExact identifier
application number: M017
ASTRAPHARM CHILLI BRANDCAPSAICINDersan Pharmaceutical Co., Ltdb4c2d4fd-7d5d-4156-ac27-e72ebc9671ec2025-01-10WarningsExact identifier
application number: M017
LABOFLEX Lidocaine Pain Relieving PatchLIDOCAINE 4%Laboflex, Inc.31995f31-c272-afdb-e063-6294a90af3f92025-01-10WarningsExact identifier
application number: M017
Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%Chain Drug Marketing Association Inc.2b48cb2f-e6bf-f9de-e063-6394a90a42d42025-01-09WarningsExact identifier
application number: M017
PAIN-XMENTHOLOL PHARMA TECH,LLCb22bb19a-14e5-3d32-e053-2a95a90ae5202025-01-09WarningsExact identifier
application number: M017
MUSCLE RUBMENTHOLOL PHARMA TECH,LLCb22c7999-52d5-25c3-e053-2a95a90a01f52025-01-09WarningsExact identifier
application number: M017
Biofreeze Professional Colorless Roll-OnMENTHOL, UNSPECIFIED FORMA-S Medication Solutionsce392c4f-cc43-484d-9c49-18fa25e4e5e92025-01-09WarningsExact identifier
application number: M017
NEW TEROCINMETHYL SALICYLATE, CAPSAICIN, AND MENTHOLA-S Medication Solutions43e5eb27-5541-4b7b-80de-55a79a4dce552025-01-09WarningsExact identifier
application number: M017
Biofreeze ProfessionalMENTHOL, UNSPECIFIED FORMA-S Medication Solutionscbeac814-59d8-4c13-8e73-bca66f797f8d2025-01-09WarningsExact identifier
application number: M017
Bactine MaxLIDOCAINEWellSpring Pharmaceutical Corporationacd7ae37-7c42-4ec7-a2ef-42e7f628388d2025-01-08WarningsExact identifier
application number: M017
THERABLAST MAXIMUM RELIEFLIDOCAINE, MENTHOLReleaf Technologies LLC09809985-3a88-9bb7-e063-6394a90a2f5f2025-01-08WarningsExact 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