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 64 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Painless Tattoo 1	BENZOCAINE	Sambria Pharmaceuticals, LLC	2f8fdcac-b87a-4191-9504-480a473f95cc	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 2	LIDOCAINE	Sambria Pharmaceuticals, LLC	180b2899-7699-40e2-974a-081a6ce2bca2	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo 3	TETRACAINE	Sambria Pharmaceuticals, LLC	9c24dcff-3988-40eb-821a-fd4b0c85f528	2025-11-12	Warnings	Exact identifier application number: M017
Tattoo Numbing Cream Co	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	2a64b3ef-ed2d-49db-996d-f63ffecb5a1e	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo Numbing	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	efd3289f-dfb2-487c-a76f-00fe8af414e3	2025-11-12	Warnings	Exact identifier application number: M017
Now Numb Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	fed833f5-4f76-46e8-8ae1-655a9e576f70	2025-11-12	Warnings	Exact identifier application number: M017
Painless Tattoo Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	852504ec-d4fa-4cae-ba89-7ffb57df8efe	2025-11-12	Warnings	Exact identifier application number: M017
Arte Maximum strength Numbing Cream	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	e612a256-3f44-46db-bb6a-e550c2216fdc	2025-11-12	Warnings	Exact identifier application number: M017
Hello Sugar	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	5f30254d-a28f-443d-8729-5c5dde4a0217	2025-11-12	Warnings	Exact identifier application number: M017
YULAM DIE DA WAN HUA PAIN RELIEVING	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	1ba3c31b-2737-4b55-a0ea-90013a1d8cf4	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: M017
TattooNumb	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	d9c4d664-54de-40c2-8836-72b60e6d9ac0	2025-11-12	Warnings	Exact identifier application number: M017
BeardedMoney	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	35ff688b-75c5-4780-b294-192af780d705	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed 7 Topical Pain Relief	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals, LLC	f199f56b-d971-4cf8-834d-babb5c2ff81a	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	8a2b6b76-6bcc-4f52-b037-e6cbc74f8377	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Anesthetic 7	LIDOCAINE HYDROCHLORIDE	Sambria Pharmaceuticals	67b25c37-db32-4980-88b0-b07712345939	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed Topical Analgesic LA	TETRACAINE HCL	Sambria Pharmaceuticals, Inc.	3c1e3a1d-f42b-499d-a445-1d1d3dd26c19	2025-11-12	Warnings	Exact identifier application number: M017
NeuroMed FA	BENZOCAINE	Sambria Pharmaceuticals, Inc.	97345ed4-51c3-4221-852c-2cd563f33317	2025-11-12	Warnings	Exact identifier application number: M017
ZHENG GU SHUI	CAMPHOR, MENTHOL	GUANGXI YULIN PHARMACEUTICAL GROUP CO LTD	17552943-4f11-42d6-ad41-fbc53f2bbd9a	2025-11-12	Warnings, Adverse reactions	Exact identifier application number: M017
NeuroMed FA	BENZOCAINE	Sambria Pharmaceuticals, Inc.	605fc242-ad31-4aa9-bd86-fba4ddf0d305	2025-11-12	Warnings	Exact identifier application number: M017
CAPZIX	CAPSAICIN	Toprail Chp Llc.	a4555840-cf8f-45d8-90bb-3581102b58a7	2025-11-12	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