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 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

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