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 91 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
HEEL PAIN Relief Gel Roll-On	MENTHOL	Guangzhou Zhupuyou E-commerce Co., Ltd	36bacb5f-c1af-2e97-e063-6394a90afe5c	2025-06-04	Warnings	Exact identifier application number: M017
Capsaicin 0.075% Cream	CAPSAICIN	ViolaCare, Inc.	30911225-a6d7-4b2b-9005-b733373e2877	2025-06-04	Warnings	Exact identifier application number: M017
LidoGuard	LIDOCAINE HCL	ViolaCare, Inc.	531383aa-4f0f-4fe0-91f4-d809b39f160f	2025-06-04	Warnings	Exact identifier application number: M017
HealthWise Lidocaine and Menthol	LIDOCAINE AND MENTHOL	Veridian Healthcare	36c27642-f913-1aad-e063-6294a90a4343	2025-06-04	Warnings	Exact identifier application number: M017
HealthWise Ultra OTC Strength Pain Relief Cream	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	Veridian Healthcare	36c3bbf9-a559-4c0d-e063-6394a90a8a1a	2025-06-04	Warnings	Exact identifier application number: M017
Everlight Survival Sting Relief Pad	BENZOCAINE	Yiwu Ori-Power Medtech Co.,Ltd.	364c9882-339e-fe22-e063-6294a90a37f4	2025-06-04	Warnings	Exact identifier application number: M017
LIGHTS Sting Relief Prep Pad	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	4f4d7758-be62-4304-8871-087a90497fa5	2025-06-04	Warnings	Exact identifier application number: M017
Elsophie Nicotine Patches Quit	NICOTINE PATCHES QUIT SMOKING	Shenzhen Xinxin Yunhai Technology Co., Ltd.	36b63da9-94cc-b52a-e063-6394a90a5029	2025-06-03	Warnings	Exact identifier application number: M017
Burn	LIDOCAINE HYDROCHLORIDE	J&A Digital Inc.	d4b09055-b93e-466f-9e24-cae098af6e24	2025-06-02	Warnings	Exact identifier application number: M017
RE-LEVE	MENTHOL	SOMBRA COSMETICS INC.	b4b39d79-0439-41e7-adca-e5ccb8f44e40	2025-05-29	Warnings	Exact identifier application number: M017
PAIN NO MORE THERAPY	MENTHOL CAMPHOR	SOMBRA COSMETICS INC.	f7bacc8e-6a8b-4cd8-bd0e-68890bee5818	2025-05-29	Warnings	Exact identifier application number: M017
DermaD ANTI-ITCH Therapeutic	SALICYLIC ACID	Chen Cohen Industries Inc.	8f4a57cb-0a5b-42b0-a325-1f92f3942ad9	2025-05-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	f7aecfb4-c194-4554-8d05-4e46005e654b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	b679ed7b-9d88-4eff-9743-567affe0fe2b	2025-05-27	Warnings	Exact identifier application number: M017
RockSauce Warming Massage Roll On	MENTHOL, METHYL SALICYLATE	Nantong Health & Beyond Hygienic Products Inc.	28eb8273-5789-4f33-bbbe-3a5ec7bc7929	2025-05-27	Warnings	Exact identifier application number: M017
AUVON Pain Relief Cream	LIDOCAINE	SHENZHEN YUWEN E-COMMERCE CO., LTD.	358c2632-3b90-1c54-e063-6294a90ad461	2025-05-22	Warnings	Exact identifier application number: M017
WelAhead by Welmate Lidocaine 5% Roll-on	LIDOCAINE 5%	OTC PHARM LLC	0b75e83e-8c7b-6247-e063-6294a90ac413	2025-05-21	Warnings	Exact identifier application number: M017
Bliss Republic	LIDOCAINE NUMBING EXTRA STRENGTH CREAM	Sargass Group Limited Liability Company	35aba13a-95e6-a395-e063-6294a90a5bdc	2025-05-21	Warnings	Exact identifier application number: M017
Xpect Stopain Clinical	MENTHOL	Cintas Corporation	e911478f-7153-4700-b945-92ec54972f45	2025-05-21	Warnings	Exact identifier application number: M017
LidoPro Patch (Lidocaine 4%, Menthol 1%)	LIDOCAINE AND MENTHOL PATCH	Preferred Pharmaceuticals Inc.	0976a898-8d79-4b85-b473-c8ad32b4fd00	2025-05-20	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