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 31 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunburn Relief GelLIDOCAINE HCLAmazon.com Services LLCadb638ec-4a7c-42f2-b249-0ac53a8dd4b22026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLAmazon.com Services LLC2acb1a6a-57e6-4915-b03a-89d1d2db3baf2026-03-03Warnings, Adverse reactionsExact identifier
application number: M017
Diphenhydramine Hydrochloride and Zinc AcetateDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATESTRATEGIC SOURCING SERVICES LLCec0c9602-35cc-4bb6-b853-794a8b5bf42e2026-03-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE 1%PHARMACY CHOICE INC4cdfe8b6-c332-7bf8-e063-6394a90abaec2026-03-03WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.4c06c4a4-557b-8bb1-e063-6294a90a91252026-03-02WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Old East Main Co.49173ec8-c94a-44c9-8a13-0f4b01b96cd62026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCL, ZINC ACETATEOld East Main Co.6d87547f-bf4c-4dda-bd9d-32b576afd8052026-03-02Warnings, Adverse reactionsExact identifier
application number: M017
Still StandingMENTHOL, UNSPECIFIED FORMNatural Essentials Inc.66974aaf-c82f-4fe9-bfb3-3430b80ac9f22026-03-02WarningsExact identifier
application number: M017
Lightning Pain ReliefMENTHOLClinical Resolution Laboratory, Inc.80af21f5-dba8-42b0-8a65-ac5a94d83ca82026-03-02WarningsExact identifier
application number: M017
Icy Hot Lidocaine No-MessLIDOCAINE HYDROCHLORIDEChattem, Inc.347f9a18-8ab6-47d3-9610-5b4e9ca5d53a2026-03-02WarningsExact identifier
application number: M017
Gold Bond Maximum Strength Foot Pain ReliefLIDOCAINE HYDROCHLORIDEGold Bond Co LLC8e469076-2f5a-4de8-8d13-a38c072b9af82026-03-01WarningsExact identifier
application number: M017
HealthWise Pain Relief LidocaineLIDOCAINE HYDROCHLORIDEVeridian Healthcare48ecbab9-13e0-d0fa-e063-6294a90a6ff22026-02-28WarningsExact identifier
application number: M017
NUMBING CREAMSLIDOCAINEYongchun Lihui Trading Co., Ltd.3b5e1a74-5946-4f1f-e063-6394a90a404b2026-02-27WarningsExact identifier
application number: M017
Pain Relieving GelLIDOCAINE HYDROCHLORIDEChain Drug Marketing Associationb55b7253-2fd2-45cc-b94c-e92395ab0d2b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
MEDISTIK PROFESSIONAL DUAL ACTIONMENTHOL, METHYL SALICYLATE, EUCALUPTUSNatureteq Inc.99c7f08a-ab14-4371-9147-189f75cb66332026-02-27WarningsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLWalmart Inc.309dcf5b-7166-976a-e063-6394a90af9522026-02-27Warnings, Adverse reactionsExact identifier
application number: M017
ASYSTEM Radical Relief Gel Roll-OnMENTHOL, METHYL SALICYLATECosco International, Inc.7239733e-5510-4a63-96c3-dd88b4a431a32026-02-27WarningsExact identifier
application number: M017
Icy Hot Pro Pain Massaging BalmCAMPHOR AND MENTHOLChattem, Inc.09e2b0cb-5186-4f9c-b256-edaced4ca0142026-02-27WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFPAI Holdings, LLC dba PAI Pharma963978de-8295-47ee-9b06-64c3521aa9942026-02-26WarningsExact identifier
application number: M017
Tommie Copper Cooling Roller Lavender ScentMENTHOL 4%Tommie Copper, Inc.4bbfd4d1-9036-bc20-e063-6394a90a3feb2026-02-26WarningsExact 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