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 129 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier application number: M017
Ultra Balm	MENTHOL AND METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	de997baf-aa04-474e-b912-3fc67e720d0b	2024-07-19	Warnings	Exact identifier application number: M017
Ling Nam Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	3f16cce3-366f-41f3-8829-6de4082a8c19	2024-07-19	Warnings	Exact identifier application number: M017
Koong Yick Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	bc33e185-3b42-98b5-e053-2995a90a6308	2024-07-18	Warnings	Exact identifier application number: M017
Koong Yick Hung Fa	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	9c8a121d-6da2-4435-a2d7-a0b71d10740d	2024-07-18	Warnings	Exact identifier application number: M017
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY ROLL-ON	PAIN RELIEF HEAT THERAPY ROLL-ON	Shenzhen Sam Technology Co., Ltd.	1d0b7b8f-9e5d-00f7-e063-6394a90af87c	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY original formula Spray.	PAIN RELIEF CRYO THERAPY ORIGINAL FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0b94ec-f956-dff2-e063-6294a90aca4a	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY MAX Strength Spray.	PAIN RELIEF CRYO THERAPY MAX STRENGTH SPRAY	Shenzhen Sam Technology Co., Ltd.	1d0bf4f9-6b02-6cec-e063-6294a90a36c7	2024-07-12	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE HCI 2.0%	Trifecta Pharmaceuticals USA, LLC.	e5e524cd-bb22-715f-e053-2995a90ab5d3	2024-07-12	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	1d10e3ca-dc93-8e1a-e063-6394a90a47c0	2024-07-12	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF HEAT THERAPY Spray.	PAIN RELIEF HEAT THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d199826-1b27-b6e7-e063-6394a90a69ad	2024-07-12	Warnings	Exact identifier application number: M017
Tidl Pain Relief Morning Therapy Spray.	PAIN RELIEF MORNING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d19d070-3818-73de-e063-6394a90a8958	2024-07-12	Warnings	Exact identifier application number: M017
Hydrocortisone with aloe	HYDROCORTISONE WITH ALOE ANTI ITCH	NeilMed Pharmaceuticals Inc.	032b9f58-5f64-04dd-e063-6294a90a6bb9	2024-07-10	Warnings	Exact identifier application number: M017
Octagon Pain Relief	MENTHOL, UNSPECIFIED FORM	NATURAL ESSENTIALS, INC.	9926f733-1506-4224-9d70-b1813cd81ec3	2024-07-08	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