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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9a29ad1b-4ba3-403f-90c9-ee7582fe4535	Available on FDA.report

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#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
CREOSOL	INACTIVE INGREDIENT	W9GW1KZG6N	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
GUAIACOL	INACTIVE INGREDIENT	6JKA7MAH9C	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
KAOLIN	INACTIVE INGREDIENT	24H4NWX5CO	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
METHYL SALICYLATE	INACTIVE INGREDIENT	LAV5U5022Y	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NUMOTIZINE (MENTHOL) OINTMENT [HOBART LABORATORIES, INC.]	4

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 30 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RICHTOFIT RAPID ACTIVE ARTHRITIS	MENTHOL AND CAMPHOR	RICHTOFIT LIMITED LIABILITY COMPANY	4b1cdab1-3e50-4ec3-e063-6394a90af75e	2026-03-12	Warnings	Exact identifier application number: M017
5Kind DMSO 4 Lidocaine HCl Pain Relieving	LIDOCAINE HYDROCHLORIDE, MENTHOL	5KIND TRADING LTD	67d8d045-7fa0-46c2-8072-645d8823903b	2026-03-11	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca541b4-7afe-77c5-e063-6294a90ad692	2026-03-10	Warnings	Exact identifier application number: M017
Lidocaine Cream, 4%	LIDOCAINE	IPG PHARMACEUTICALS, INC.	7775bfdd-7eac-4f09-b83f-fc4a16a24558	2026-03-10	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	CHEMCO CORPORATION	4c989283-9a27-e8d2-e063-6294a90a8bfa	2026-03-09	Warnings	Exact identifier application number: M017
Prequel Anti-Itch Solution Medicated Calming	MEDICATED CALMING LOTION	The Center Brands, LLC	419fa45b-992b-676e-e063-6394a90add81	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	1fda69f7-2bb6-42fc-bcef-677e7b3d7f01	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee	MENTHOL, LAUROCAPRAM	Planet (Anhui) Pharmaceutical Co., Ltd.	7577625c-87eb-4639-aeab-8a2ab97033fd	2026-03-09	Warnings	Exact identifier application number: M017
Careland Lidocaine Pain Relieving	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4	2026-03-09	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4%	RAPID AID VIET NAM COMPANY LIMITED	4ca35030-958c-8f62-e063-6294a90a4d63	2026-03-09	Warnings	Exact identifier application number: M017
Welmate Lidocaine Pain Relieving Patch	LIDOCAINE	YYBA Corp	cff71b75-fc4e-29ac-e053-2995a90abd50	2026-03-06	Warnings	Exact identifier application number: M017
Heal and Rescue Bunion Pain Relief	LIDOCAINE HCL, MENTHOL	Rooftop Consumer Health, Inc	4c60d4d3-e0a9-6f93-e063-6394a90a16af	2026-03-06	Warnings	Exact identifier application number: M017
JUST CBD - PAIN RELIEF	MENTHOL, CAMPHOR	Just Brands LLC	4c493c0b-c58e-cb56-e063-6394a90a9395	2026-03-05	Warnings	Exact identifier application number: M017
Hug a BooBoo Medicated booboo Wipes	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	509aaafc-2ef7-4205-818c-7ff5b146e159	2026-03-04	Warnings	Exact identifier application number: M017
CVS Foot Pain	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4c3350c3-2e3e-093c-e063-6394a90a3475	2026-03-04	Warnings	Exact identifier application number: M017
Game On Sport	MENTHOL	Natural Essentials, Inc	4c3411dc-5378-bd93-e063-6394a90a8406	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	f4d4a56b-b4b7-9a07-e053-2a95a90ad853	2026-03-04	Warnings	Exact identifier application number: M017
Hydrocortisone 1%	HYDROCORTISONE	Trifecta Pharmaceuticals Usa Llc	9987165c-1a0f-dd57-e053-2a95a90ae735	2026-03-04	Warnings	Exact identifier application number: M017
Walgreens Unscented Pain Relieving	LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL	Walgreen Co.	41eadb4f-2ca5-42a1-e063-6294a90ab4e2	2026-03-04	Warnings	Exact identifier application number: M017
Careland Pain Relief Patch Plus	LIDOCAINE	Planet (Anhui) Pharmaceutical Co., Ltd.	d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3	2026-03-04	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1233196	menthol 1.25 % Topical Ointment	PSN	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	NUMOTIZINE 1.25 % Topical Ointment	PSN	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	menthol 0.0125 MG/MG Topical Ointment [Numotizine]	SBD	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233196	menthol 0.0125 MG/MG Topical Ointment	SCD	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	Numotizine 0.0125 MG/MG Topical Ointment	SY	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8
1233201	Numotizine 1.25 % Topical Ointment	SY	9a29ad1b-4ba3-403f-90c9-ee7582fe4535	8

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