Analgesic

Product NDC: 61010-8200
11-digit product format: 610108200
Labeler code: 61010
Product ID: 61010-8200_12b7defb-8710-5fd7-e063-6294a90a8a03
Type: HUMAN OTC DRUG
Nonproprietary name: menthol
Dosage form: SPRAY
Route: TOPICAL
Labeler: Safetec of America, Inc.
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-10-26
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 70 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61010-8200-1	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61010-8200-1	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61010-8200-1	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61010-8200-1	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61010-8200-1	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61010-8200-1	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61010-8200-1	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61010-8200-1	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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: Analgesic
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	70 mg/mL

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
1086713	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
b0f4010c-995f-40e1-aa40-92760e697a61	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61010-8200-1	2024-04-09	C162847	48780-1	9d75b9cf-e7c5-f424-e053-dadaa90a57ce	61010-8200, PAIN SPRAY
61010-8200-1	2020-01-31	C162847	48780-1	9d75b9cf-e7c5-f424-e053-dadaa90a57ce	61010-8200, PAIN SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61010-8200-1	Analgesic	118 mL in 1 BOTTLE, SPRAY	SPRAY	118		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
menthol	ACTIVE INGREDIENT	L7T10EIP3A	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
menthol	ACTIVE MOIETY	L7T10EIP3A	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
coconut oil	INACTIVE INGREDIENT	Q9L0O73W7L	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
eucalyptus oil	INACTIVE INGREDIENT	2R04ONI662	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
methyl salicylate	INACTIVE INGREDIENT	LAV5U5022Y	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
peppermint oil	INACTIVE INGREDIENT	AV092KU4JH	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61010-8200	ANALGESIC (MENTHOL) SPRAY [SAFETEC OF AMERICA, INC.]	2	Current NDC, Legacy NDC, 1 package rows	20240410_b0f4010c-995f-40e1-aa40-92760e697a61.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 46 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lidocaine 4% Topical Anesthetic Cream	LIDOCAINE 4%	Oncor Pharmaceuticals	1baaa669-05af-4024-a0ba-ee3451756f6a	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	6834a6de-4d1d-4e40-945d-ec5c267abd14	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	ee8cd550-64ee-432e-98e5-b68083179a3c	2026-01-05	Warnings	Exact identifier application number: M017
REGENECARE HA	LIDOCAINE HCL	MPM Medical LLC	0eee554f-dfe0-433a-9665-8bdb95229888	2026-01-05	Warnings	Exact identifier application number: M017
Pain Relieving Cream	CAMPHOR AND MENTHOL	PAIN WIZARD LIMITED LIABILITY COMPANY	2647bba1-87f4-3c16-e063-6394a90ae0c9	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Lidocaine plus Menthol	LIDOCAINE, MENTHOL	Veridian Healthcare	efddd116-d753-425a-9ded-09b8045024e4	2026-01-05	Warnings	Exact identifier application number: M017
TheraCare Original Menthol	MENTHOL	Veridian Healthcare	ea56e4e1-a758-428b-8758-ee31bb00ca82	2026-01-05	Warnings	Exact identifier application number: M017
Mugwort Patch (Cervical spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e220c-0d35-9ee0-e063-6294a90ab689	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Lumbar spine use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e4b21-6d81-4cd3-e063-6394a90a18fe	2026-01-04	Warnings	Exact identifier application number: M017
Mugwort Patch (Knee use)	2%MENTHOL	YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED	478e86d2-3030-91eb-e063-6394a90a4db0	2026-01-04	Warnings	Exact identifier application number: M017
American Safety and First Aid	HYDROCORTISONE ACETATE	Orazen Inc	4a543f90-d43c-4487-b27e-f43394c6320d	2026-01-04	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	50123bb9-d5d8-4ba6-ab94-8ed95fe0f5a8	2026-01-02	Warnings	Exact identifier application number: M017
Doctor Hoys Pain Relief Gel Roll-On	MENTHOL, CAMPHOR (SYNTHETIC)	Dynamic Blending Specialists, Inc.	bf47acb2-6c90-4d5c-820b-447cac9305a4	2026-01-02	Warnings	Exact identifier application number: M017
Amino Rip Muscle Pain Relief	LIDOCAINE HCL	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	2bed5764-4217-4aa3-9d90-3b5460dcffa3	2026-01-02	Warnings	Exact identifier application number: M017
Menthozen Cream	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	63bb0283-cfbe-4e9c-8772-73062c0c8d05	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen Hydrogel	MENTHOL, CAPSAICIN	Village Pharma LLC	4c979a71-7c8f-4dff-abae-bf4cdf8f67b4	2026-01-01	Warnings	Exact identifier application number: M017
Lidozen Gel	LIDOCAINE HYDROCHLORIDE, MENTHOL	Village Pharma LLC	ffb7831f-4ca9-4d73-8303-e9cd90078982	2026-01-01	Warnings	Exact identifier application number: M017
Sting Relief	BENZOCAINE, ISOPROPYL ALCOHOL	Yiwu Ori-Power Medtech Co.,Ltd.	116ee6dc-9c49-2e11-e063-6394a90a44ed	2026-01-01	Warnings	Exact identifier application number: M017
Menthozen	METHYL SALICYLATE, MENTHOL, CAPSAICIN	Village Pharma LLC	48b1b99e-d0ec-4e5c-b80c-c0d2d87ecb13	2026-01-01	Warnings	Exact identifier application number: M017
NUVALU ICE THERAPY MENTHOL PAIN RELIEVING	MENTHOL	JC SALES	5adf457e-b4d0-30c8-e063-6294a90a64b9	2026-01-01	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
1086713	menthol 7 % Topical Spray	PSN	b0f4010c-995f-40e1-aa40-92760e697a61	2
1086713	menthol 70 MG/ML Topical Spray	SCD	b0f4010c-995f-40e1-aa40-92760e697a61	2
1086713	menthol 7 % Topical Spray	SY	b0f4010c-995f-40e1-aa40-92760e697a61	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
61010-8200-1	61010820001	118 mL in 1 BOTTLE, SPRAY (61010-8200-1)	118 ml	2011-10-26	No	No	Current