Pain Relieving

Product NDC: 61010-4403
11-digit product format: 610104403
Labeler code: 61010
Product ID: 61010-4403_10aa8eb6-5d50-bea9-e063-6394a90a3623
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: GEL
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-11-01
Substance: MENTHOL
Active strength: 4 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: Pain Relieving
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	4 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
415974	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
52ebf64d-095f-467e-bf51-dd8d33b58c7d	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-4403-1	2024-02-13	C162847	48780-1	1030e365-2c4c-111a-e063-dadaa90a10e2	61010-4403-1
61010-4403-1	2024-01-30	C162847	48780-1	1030e365-2c4c-111a-e063-dadaa90a10e2	61010-4403-1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-4403-1	Pain Relieving	113.4 g in 1 TUBE	GEL	113.4		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-4403	PAIN RELIEVING (MENTHOL) GEL [SAFETEC OF AMERICA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240214_52ebf64d-095f-467e-bf51-dd8d33b58c7d.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 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
LidoReal Patch	LIDOCAINE AND MENTHOL	FORREAL PHARMACEUTICALS LLC	19f1c037-b4b8-47b0-b0f9-036691c1d307	2024-07-05	Warnings	Exact identifier application number: M017
Lip Medex Lip Balm	PETROLATUM, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL	Blistex Inc.	988f97e8-a59f-4bc0-9d71-60607364a686	2024-07-01	Warnings	Exact identifier application number: M017
Maybelline New York BABY LIPS DR RESCURE MENTHOL EXTERNAL ANALGESIC MEDICATED BALM	MENTHOL	L'Oreal USA Products Inc	d580982f-dda6-4b03-bf84-342b9f2c6d93	2024-06-29	Warnings	Exact identifier application number: M017
Lip Medex Cherry	PETROLATUM, CAMPHOR (SYNTHETIC), AND MENTHOL, UNSPECIFIED FORM	Blistex Inc.	fa8b3fb1-08e5-4876-9c4a-6aa8c9f23af8	2024-06-28	Warnings	Exact identifier application number: M017
10% Methyl Salicylate Pain Relief Patch	10% METHYL SALICYLATE	Akron Coating & Adhesives	1be1f1ce-3238-a8ed-e063-6294a90a5aed	2024-06-27		Exact identifier application number: M017
Genuine First Aid Alcohol Cleansing Pad	BENZOCAINE, ALCOHOL	GFA Production (Xiamen) Co., Ltd.	c39c4d80-9718-459f-8ae4-ada043bba5b7	2024-06-26	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	1bd5cf69-9a08-5e2e-e063-6394a90a03cd	2024-06-26	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	2c0389db-ceb2-422b-9575-bdb8fe649a1e	2024-06-26	Warnings	Exact identifier application number: M017
astonea	HYDROCORTISONE	ASTONEA LABS PRIVATE LIMITED	de09e859-c5fd-0cc5-e053-2a95a90a147e	2024-06-25	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Lidocaine Patch	LIDOCAINE 4%	Veridian Healthcare	0190196d-5f78-042b-e063-6294a90a3714	2024-06-25	Warnings	Exact identifier application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
415974	menthol 4 % Topical Gel	PSN	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2
415974	menthol 0.04 MG/MG Topical Gel	SCD	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2
415974	menthol 4 % Topical Gel	SY	52ebf64d-095f-467e-bf51-dd8d33b58c7d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-4403-1	61010440301	113.4 g in 1 TUBE (61010-4403-1)	113.4 g	2019-11-01	0000-00-00	No	No	Current