Pain Relieving Roll-On

Product NDC: 61010-1550
11-digit product format: 610101550
Labeler code: 61010
Product ID: 61010-1550_10a91ff8-4d59-15dd-e063-6394a90a3aad
Type: HUMAN OTC DRUG
Nonproprietary name: menthol, unspecified form
Dosage form: GEL
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-07
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 7 g/100mL
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 Roll-On
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	7 g/100mL

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
311509	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
80118260-9c88-402d-9a90-ecfe62b4b54f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-1550-1	2024-02-13	C162847	48780-1	1030e365-516c-111a-e063-dadaa90a10e2	61010-1550-1, Pain Relieving Roll-on
61010-1550-1	2024-01-30	C162847	48780-1	1030e365-516c-111a-e063-dadaa90a10e2	61010-1550-1, Pain Relieving Roll-on

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-1550-1	Pain Relieving Roll-On	88 mL in 1 BOTTLE	GEL	88		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-1550	PAIN RELIEVING ROLL-ON (MENTHOL, UNSPECIFIED FORM) GEL [SAFETEC OF AMERICA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240214_80118260-9c88-402d-9a90-ecfe62b4b54f.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 81 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LILAS PERIOD	MENTHOL	Lilas Wellness, Inc.	5ea53b4b-45e6-48a7-8090-09c3a21e7f63	2025-08-11	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Gel Roll-On	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	31639407-0f11-bde2-e063-6294a90af694	2025-08-10	Warnings	Exact identifier application number: M017
Chinese Red Tiger Lidocaine Patches	LIDOCAINE	Guangzhou Zhupuyou E-commerce Co., Ltd	20cd369c-3e98-3d8f-e063-6394a90a0824	2025-08-10	Warnings	Exact identifier application number: M017
Treatonic LIDOCAINE PAIN RELIEF	LIDOCAINE 4%	100 KARMA INC	3bd66b03-ac82-2d45-e063-6294a90a610a	2025-08-08	Warnings	Exact identifier application number: M017
Capsaicin 0.025%	CAPSAICIN 0.025%	Advanced Rx of Tennessee, LLC	3bdcef94-d06f-9152-e063-6294a90a6072	2025-08-08	Warnings	Exact identifier application number: M017
MENTHOL 5%	MENTHOL 5%	Advanced Rx of Tennessee, LLC	3bdd0c52-29d8-ab67-e063-6294a90a9c45	2025-08-08	Warnings	Exact identifier application number: M017
Methyl Salicylate 25% Cream	METHYL SALICYLATE	Advanced Rx of Tennessee, LLC	3bdd3015-349a-0fac-e063-6394a90afe41	2025-08-08	Warnings	Exact identifier application number: M017
LIDOCAINE 4%	LIDOCAINE 4%	Advanced Rx of Tennessee, LLC	3bdd6b3d-7180-288c-e063-6394a90a1785	2025-08-08	Warnings	Exact identifier application number: M017
Good Sense Pain Relief Roll On	LIDOCAINE HCL	Geiss, Destin & Dunn, Inc	38e76fd6-e5fb-493c-e063-6294a90afed4	2025-08-08	Warnings	Exact identifier application number: M017
Aruba Aloe Alcoholada	LIDOCAINE HYDROCHLORIDE	Aruba Aloe Balm NV	f56c62b0-75db-4499-858e-54e10b0e140a	2025-08-07	Warnings	Exact identifier application number: M017
SurviveX Hydrocortisone Cream	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	3bd1da8d-5142-798c-e063-6294a90a7be6	2025-08-07	Warnings	Exact identifier application number: M017
Arthcal SOOTHING PAIN RELIEF MASSAGE	SOOTHING PAIN RELIEF MASSAGE	Beijing JUNGE Technology Co., Ltd.	3524ad62-0ed6-f2e5-e063-6394a90a3283	2025-08-06	Warnings	Exact identifier application number: M017
Alumier MD Intensive Recovery	HYDROCORTISONE	Alumier Labs	d9b79ea1-6558-543c-e053-2995a90ae53e	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Pain Relief	LIDOCAINE HCL	Amerisource Bergen	a0c3adbf-fa35-47c0-9db3-459ce9a106ac	2025-08-06	Warnings	Exact identifier application number: M017
Good Neighbor Roll-on Menthol Pain Relief Gel	MENTHOL	Amerisource Bergen	bd557323-0003-4ee6-b22d-a72d621c7de4	2025-08-05	Warnings	Exact identifier application number: M017
Earthmed FS Pain relieving balm	MENTHOL	Earthmed LLC	3ba4e769-fec6-52d9-e063-6394a90a65d4	2025-08-05	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	HF Acquisition Co LLC, DBA HealthFirst	3ba6a5ec-fda2-b2a6-e063-6294a90ac9b6	2025-08-05	Warnings	Exact identifier application number: M017
Kocowo Lidocaine Pain Relief Gel-Patch	LIDOCAINE PAIN RELIEF GEL-PATCH	Henan Enokon Medical Instrument Co., Ltd.	3b82989d-7cc3-23d3-e063-6294a90ae2a3	2025-08-03	Warnings	Exact identifier application number: M017
Menthol pain relief patches	MENTHOL	Menthol pain relief patch	3b5fd718-3f86-f7a7-e063-6294a90a8c52	2025-08-02	Warnings	Exact identifier application number: M017
Graphene Far Infrared Herbal Pain Relief Patches	CORYDALIS RHIZOME	Changsha Maocheng Trading Co., Ltd	3b604a3c-fe91-7096-e063-6394a90afe04	2025-08-02	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311509	menthol 7 % Topical Gel	PSN	80118260-9c88-402d-9a90-ecfe62b4b54f	2
311509	menthol 0.07 MG/MG Topical Gel	SCD	80118260-9c88-402d-9a90-ecfe62b4b54f	2
311509	menthol 7 % Topical Gel	SY	80118260-9c88-402d-9a90-ecfe62b4b54f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61010-1550-1	61010155001	88 mL in 1 BOTTLE (61010-1550-1)	88 ml	2019-10-07	0000-00-00	No	No	Current