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 133 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	1dc21c95-b419-4175-85f8-040b73060d37	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Roll-On Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	d94ae654-ce25-4bff-b9bd-24a0e0e8568a	2024-03-20	Warnings	Exact identifier application number: M017
Pain Relief Muscle	CAMPHOR (NATURAL)	J.R. Watkins, LLC.	f8bff018-fb4f-47b4-b8f8-4a496aede346	2024-03-20	Warnings	Exact identifier application number: M017
Rugby Arthritis Pain Relieving Topical Analgesic	CAPSAICIN	Rugby Laboratories	8f1bc075-97ac-4154-8768-0d878104c3ba	2024-03-14	Warnings	Exact identifier application number: M017
Rugby Ice Blue External Analgesic	MENTHOL, UNSPECIFIED FORM	Rugby Laboratories	2b65cb6a-4364-4770-b7b9-5c4637edd01a	2024-03-14	Warnings	Exact identifier application number: M017
Leader Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	fd06d17f-4dff-42a9-a84f-904809ceb981	2024-03-13	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	EROS GLOBAL	b3495c95-ba4b-9459-e053-2a95a90a710f	2024-03-12	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	1369e70f-7a61-7078-e063-6394a90a9a88	2024-03-11	Warnings	Exact identifier application number: M017
Pain Reliever Cream	MENTHOL 10%, METHYL SALICYLATE 15%	Trifecta Pharmaceuticals USA, LLC.	130665d6-3de8-cb91-e063-6294a90a2083	2024-03-06	Warnings	Exact identifier application number: M017
Dermachange Aid Anti-Itch	DIPHENHYDRAMINE HCL	Private Label Beauty and Wellness	12ed906c-d028-0ff7-e063-6394a90aaa52	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	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