Home NDC 10546-100 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 Ingredient Strength MENTHOL 1.25 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1233196 Internal RxNorm lookup 1233201 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10546-100-08 NUMOTIZINE 228 g in 1 JAR OINTMENT 228 8 10546-100-35 NUMOTIZINE 99 g in 1 JAR OINTMENT 99 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10546-100 NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.] 8 Current NDC, Legacy NDC, 2 package rows 20231021_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 99 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrocortisone with aloe HYDROCORTISONE Encube Ethicals, Inc. 12a1774d-a97e-4787-b6b1-8e8cd40b7b70 2025-02-26 Warnings Exact identifier application number: M017 Thera Plus Maximum Strength Feminine Anti-Itch BENZOCAINE, RESORCINOL FOURSTAR GROUP USA, INC. 0007e3ea-882b-4000-8e70-2bcec2c08613 2025-02-26 Warnings Exact identifier application number: M017 Tattoo numbing cream LIDOCAINE BLOOMWELL GARDENS LLC 2ea9d34e-408d-f8d6-e063-6394a90a72a4 2025-02-26 Warnings Exact identifier application number: M017 Icy Hot Pro No-Mess CAMPHOR, MENTHOL Chattem, Inc. 9e8fedf5-fb59-4531-b288-715f851ee05b 2025-02-26 Warnings Exact identifier application number: M017 Family Wellness Max Strength 1 Hydrocortisone Cream HYDROCORTISONE Family Dollar Stores, Inc bca5ac2c-45cd-44e3-98f1-317a04e44d7d 2025-02-25 Warnings Exact identifier application number: M017 Tylenol Precise Nighttime Pain Relieving CAMPHOR, MENTHOL Kenvue Brands LLC 2ef4fe16-0820-6aad-e063-6294a90a8449 2025-02-25 Warnings Exact identifier application number: M017 LidoPro Pain Relief CAPSAICIN AND LIDOCAINE Preferred Pharmaceuticals Inc. c259ef92-5d07-4590-adf1-3a106333eee0 2025-02-21 Warnings Exact identifier application number: M017 Cortizone 10 Ultra Soothing Itch Relief HYDROCORTISONE Chattem, Inc. 8a9e2d32-a65f-4253-8041-4146f4e3b738 2025-02-21 Warnings Exact identifier application number: M017 AVCOO Pain Relief Roll On MENTHOL ADP Health Limited 420d8cdc-f47f-4d33-bf25-9033ff266c49 2025-02-19 Warnings Exact identifier application number: M017 AVCOO Pain Relief MENTHOL ADP Health Limited 700ce2cf-749e-40be-91c3-850d9b2168ca 2025-02-19 Warnings Exact identifier application number: M017 Sunburn Relief Gel LIDOCAINE HCL Jell Pharmaceuticals Pvt. Ltd 2e7c49de-5438-4858-e063-6294a90ad98c 2025-02-19 Warnings Exact identifier application number: M017 VTROUY Tattoo Numbing Cream TATTOO NUMBING CREAM Guangzhou Zanming Trading Co., Ltd. 2e899851-b3cd-0758-e063-6294a90afea8 2025-02-19 Warnings Exact identifier application number: M017 Pomada Dragon Pain Relief MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND METHYL SALICYLATE Genomma Lab USA 9d98f48b-6d88-4df9-9459-7cf7ba5de044 2025-02-19 Warnings Exact identifier application number: M017 Pain Relieving Cream HISTAMINE DIHYDROCHLORIDE Mediapower, Inc. DBA Dr Newton's And Naturals 9eeea033-ae87-4d83-85d0-b8fa653a0806 2025-02-19 Warnings Exact identifier application number: M017 Sure Complete Confidence Antiperspirant Deodorant Aerosol, Regular ALUMINUM CHLOROHYDRATE Sodalis USA, LLC 7839cf53-dbd2-4dbb-a309-1581d51f8adc 2025-02-18 Warnings Exact identifier application number: M017 CANNA NUMB Roll On LIDOCAINE HYDROCHLORIDE, MENTHOL Cannanumb LLC c1eb0348-3b0e-4f1c-a46b-1ff4aa165fb4 2025-02-17 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 7173b141-123e-6cd4-e053-2a95a90a8600 2025-02-12 Warnings Exact identifier application number: M017 Vaporizing Chest Rub 4 oz. 3 pk CAMPHOR, EUCALYPTUS OIL, MENTHOL Rejoice International Inc. 71c186a1-8283-2482-e053-2995a90acc1f 2025-02-12 Warnings Exact identifier application number: M017 Roman Swipes BENZOCAINE Roman Health Ventures Inc. 7f0eac8c-7235-99d8-e053-2a91aa0a634e 2025-02-12 Warnings Exact identifier application number: M017 SANAR NATURAL-ARNICA ROLL ON ARNICA PAIN RELIEVING WITH CAMPHOR EVI LABS EVI LABS 2df7658d-83d3-41ac-e063-6294a90ab1dd 2025-02-12 Warnings Exact identifier application number: M017
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10546-100-08 10546010008 228 g in 1 JAR (10546-100-08) 228 g 2011-11-30 0000-00-00 No No Current 10546-100-35 10546010035 99 g in 1 JAR (10546-100-35) 99 g 2011-11-30 0000-00-00 No No Current