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 144 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr PAINES Pain Relief	MENTHOL	DOCTOR PAINE'S MEDICAL, LLC	79d2b332-051e-48c1-afe8-6d4468cd1878	2023-11-11	Warnings	Exact identifier application number: M017
INTIMALE Maximum Strength Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25b9ade3-72b0-4b86-8c48-90310a26806f	2023-11-11	Warnings	Exact identifier application number: M017
POWERECT Max Power Male Delay	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	25a1c926-9543-44a7-865e-a4b6e1a40cbe	2023-11-11	Warnings	Exact identifier application number: M017
SKINS DELAY Maximum Strength Lidocaine	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	172efe5d-28b8-443c-b3f9-429669189081	2023-11-11	Warnings	Exact identifier application number: M017
GASPARI Ageless Pain Relief Cream	MENTHOL	GASPARI ANTI-AGING LLC	ea806089-688b-4944-ad69-86f366509eb5	2023-11-11	Warnings	Exact identifier application number: M017
ZENSEZONE Arthmed Temporary Pain Relief Cream	CAPSAICIN, MENTHOL, METHYL SALICYLATE	ZENSEZONE LLC	c5778f22-c411-4bd7-b2af-45e3fee15fd2	2023-11-11	Warnings	Exact identifier application number: M017
PRFC HEMP Topical Analgesic	MENTHOL	DOBEST INC	722da9d1-91d7-45be-adb1-8d6a22aa83ac	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	84ea496e-ab54-4882-93ef-600f8eb33cb4	2023-11-11	Warnings	Exact identifier application number: M017
AMP RELIEF Pain Relief Cream	MENTHOL	COASTAL FORMULAS LLC	39564c67-49ab-42d4-a391-792ac69180c0	2023-11-11	Warnings	Exact identifier application number: M017
LIDOSOLVE PAIN RELIEF	LIDOCAINE HYDROCHLORIDE	HENNIKA HEALTH, LLC	3a9e4e0c-362d-4e66-bb5f-984fe1c9d4e2	2023-11-11	Warnings	Exact identifier application number: M017
AMINO ACTIVE Topical Analgesic Cream	HISTAMINE DIHYDROCHLORIDE	VIREO SYSTEMS, INC.	591b1e7e-a8c0-4640-a592-4e0f3538a40e	2023-11-11	Warnings	Exact identifier application number: M017
NERVE ACTIVE Pain Relief Cream	MENTHOL	TOP DOG DIRECT, LLC	a8b85dcb-fd3e-4340-a945-609fc741443c	2023-11-11	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back	LIDOCAINE	Geri-Gentle Corporation	e4427928-c063-9ca6-e053-2995a90a1aa1	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and Neck	MENTHOL	Geri-Gentle Corporation	e4429f70-667e-662b-e053-2a95a90a62ba	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Back	MENTHOL	Geri-Gentle Corporation	e442b8ec-a3de-65e8-e053-2995a90af3ec	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	9f948fb4-4275-4a1f-83f8-cd708db4a296	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF PAIN RELIEF	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	b4278b70-e9a6-4d1f-bbad-257fe437b86a	2023-11-10	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain Relief	MENTHOL, CAPSAICIN	BLUE SPRING WELLNESS, L.L.C.	2f9cf514-48be-49ec-b424-0b228b4b874a	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	1231ddd2-7661-45b2-ab15-32f7fdc078a8	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE Stuff Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	7779b26b-ae3b-4639-a6b0-826c7ab37a86	2023-11-10	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