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 87 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Neighbor Pharmacy Hydrocortisone with Aloe	HYDROCORTISONE	AmerisourceBergen	0c544792-63d9-400c-9888-207c44fdc75e	2025-07-08	Warnings	Exact identifier application number: M017
Good Neighbor Pharmacy Hydrocortisone	HYDROCORTISONE	AmerisourceBergen	58b0b7ba-e547-4e0f-b04d-8e1e6a5d4fcf	2025-07-08	Warnings	Exact identifier application number: M017
Publix Hydro	HYDROCORTISONE	Publix Super Markets Inc	29296b0f-0eed-4bb9-8727-c25c2bcf9fd6	2025-07-08	Warnings	Exact identifier application number: M017
Publix hydro plus	HYDROCORTISONE	Publix Super Markets Inc	a00d82c1-6b09-424a-be78-2603eee3fb9d	2025-07-08	Warnings	Exact identifier application number: M017
Tattoo	TATTOO CREAM	Perfso (HK) Co., Limited	39773cab-12df-4520-e063-6294a90abc5b	2025-07-08	Warnings	Exact identifier application number: M017
Neutrogena Sun Rescue After Sun Medicated Relief	CAMPHOR (SYNTHETIC)	Kenvue Brands LLC	c95c5b64-b90f-1143-e053-2a95a90aa03c	2025-07-07	Warnings	Exact identifier application number: M017
sunmark Hydrocortisone	HYDROCORTISONE	Strategic Sourcing Services LLC	210079e9-3d2f-4489-b468-b96b145034ed	2025-07-07	Warnings	Exact identifier application number: M017
Relief Gel	LIDOCAINE HCL	Good Clean Love, Inc.	e5fa2265-ccb7-750c-e053-2995a90aa51e	2025-07-07	Warnings	Exact identifier application number: M017
Hydrocortisone Plus 12 Moisturizers	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	09ac2749-a60f-4039-8c80-a0d2eaf50c34	2025-07-07	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	2ada9ec2-1c28-4da2-8639-07b3193ffb32	2025-07-03	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE	Sun Pharmaceutical Industries, Inc.	caa2fd64-e262-4d7c-ad8a-69f506feba8c	2025-07-03	Warnings	Exact identifier application number: M017
Stopain Extra Strength	MENTHOL	Troy Manufacturing, Inc.	07e9a235-6d10-4407-8729-beaf936e97ad	2025-07-03	Warnings	Exact identifier application number: M017
Blue Ice Topical Analgesic Gel	ICE GEL	International Wholesale	397cd306-078d-5b7d-e063-6294a90a8bbc	2025-07-03	Warnings	Exact identifier application number: M017
LIDOCAINE	LIDOCAINE, MENTHOL	Vive Health LLC	236ccc6d-21b7-6153-e063-6394a90a4634	2025-07-02	Warnings	Exact identifier application number: M017
AsperFlex MAX	LIDOCAINE 4% WITH MENTHOL 1%	Akron Pharma Inc.	ccf6172b-350a-4b78-b844-f84bf17c491f	2025-07-02	Warnings	Exact identifier application number: M017
METHYL SALICYLATE 25%	METHYL SALICYLATE	Oncora Pharma, LLC	3766e3a9-94a8-4c3e-e063-6394a90aa24a	2025-07-01	Warnings	Exact identifier application number: M017
Diphenhydramine Hydrochloride and Zinc Acetate	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Sun Pharmaceutical Industries, Inc.	c89e3de8-7d71-485c-8fc5-2832d6024f16	2025-07-01	Warnings	Exact identifier application number: M017
Westlake Outdoor Pain and Itch Relieving	LIDOCAINE 4% PAIN AND ITCH RELIEVING	WESTLAKE HB PHARMA	3c563b28-4f4f-9d0c-e063-6294a90adf73	2025-07-01	Warnings	Exact identifier application number: M017
Cortizone 10 Water Resistant	HYDROCORTISONE	Chattem, Inc.	118e55e7-241f-44c4-959e-09bf6221bd77	2025-07-01	Warnings	Exact identifier application number: M017
Quit Smoking Nicotine Patches	NICOTINE TRANSDERMAL PATCHES	Shenzhen Paxi Trading Co., Ltd.	38c1616e-3b09-0669-e063-6294a90a2c86	2025-06-29	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