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 101 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magsoothium CBD Cooling Roll on Relief	MENTHOL	Ubu/Elements, Inc.	2cf05dcd-6a44-de08-e063-6394a90aaba0	2025-01-30	Warnings	Exact identifier application number: M017
Meijer Vagicaine	20% BENZOCAINE AND 3% RESORCINOL CREAM	Meijer, Inc.	dac73a07-7569-4788-977a-f10d098da75d	2025-01-30	Warnings	Exact identifier application number: M017
ZCort Ultra	HYDROCORTISONE ACETATE 1%	RxDino, LLC	b68f8ada-58e8-e8e4-e053-2a95a90ab02d	2025-01-29	Warnings	Exact identifier application number: M017
Lidocaine Pain Relieving Gel-Patch	LIDOCAINE 4%	Noble OTC LLC	12a3ce63-6fce-0993-e063-6294a90a40d5	2025-01-28	Warnings	Exact identifier application number: M017
INTIMALE LIDOCAINE DELAY	LIDOCAINE HYDROCHLORIDE	SKINS SEXUAL HEALTH LIMITED	5ddd7d56-bf51-462b-afcd-944861e49781	2025-01-28	Warnings	Exact identifier application number: M017
CBD Clinic Relax Massage	CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0eae24e-09cf-0d2d-e053-2a95a90acedc	2025-01-28	Warnings	Exact identifier application number: M017
CBD Clinic Pain Relief - Level 5	MENTHOL, CAMPHOR	ABACUS HEALTH PRODUCTS, INC.	f0ebbc0f-9888-b812-e053-2a95a90a5d3d	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Arthritis Aches and Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec7255-bb36-41cd-e053-2a95a90aeac4	2025-01-28	Warnings	Exact identifier application number: M017
CBDMEDIC Back and Neck Pain Relief	CAMPHOR AND MENTHOL	ABACUS HEALTH PRODUCTS, INC.	f0ec8fc9-c401-5f23-e053-2995a90acb1c	2025-01-28	Warnings	Exact identifier application number: M017
Muscle Therapy	METHYL SALICYLATE, CAMPHOR	Everlaan Organics Inc	0890a683-9a66-fdbd-e063-6294a90ae526	2025-01-27	Warnings	Exact identifier application number: M017
Joint Therapy	CAMPHOR	Everlaan Organics Inc	08904b77-d6db-8b82-e063-6394a90ace4f	2025-01-27	Warnings	Exact identifier application number: M017
Warrior Arthritis Relief	TROLAMIN SALICYLATE 10%	Derma Care Research Labs, LLC	013f48b9-913f-b283-e063-6394a90abd73	2025-01-27	Warnings	Exact identifier application number: M017
DCH Cool and Heat	MENTHOL 16%	Derma Care Research Labs, LLC	ff323282-612c-eaf8-e053-6394a90ab779	2025-01-27	Warnings	Exact identifier application number: M017
Gerigentle	HYDROCORTISONE	GERI-GENTLE CORPORATION	0adfa2f0-9758-5c54-e063-6294a90a461f	2025-01-25	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving	MENTHOL, CAMPHOR	Active and Innovative Inc.	42f1abeb-f6d7-01c3-e054-00144ff88e88	2025-01-23	Warnings	Exact identifier application number: M017
FORTHiQ Pain Relief Lidocaine Patch	PAIN RELIEF LIDOCAINE PATCH	Henan Enokon Medical Instrument Co., Ltd.	2c593420-5788-3422-e063-6394a90a1890	2025-01-22	Warnings	Exact identifier application number: M017
RETALIEF LIDOCAINE 5	LIDOCAINE	Reliable 1 Laboratories LLC	2c262f3c-8cb2-4384-e063-6294a90a436d	2025-01-20	Warnings	Exact identifier application number: M017
Eagle Brand Medicated Roll On Aromatic	CAMPHOR, MENTHOL, METHYL SALICYLATE	Borden Company (Private) Limited	1c3e5068-dd61-ebdb-e063-6294a90a97cc	2025-01-20	Warnings	Exact identifier application number: M017
PROHEAL BURN	LIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE	Nantong Health & Beyond Hygienic Products Inc.	bbc0a5d6-1de6-4ca3-9bb4-a45662b5eab1	2025-01-19	Warnings	Exact identifier application number: M017
HERSTAT PLUS Cold Sore Treatment	CAMPHOR, MENTHOL	Herstat (USA) Inc.	e20ea714-663d-c4ac-e053-2a95a90a5ecc	2025-01-18	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