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 76 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FL Burn Ease, 0.9g	LIDOCAINE	ProStat First Aid LLC	4dc0d579-ab42-4ea5-9788-5e54d7d318a3	2025-10-01	Warnings	Exact identifier application number: M017
Carmex Classic Lip Balm Medicated	CAMPHOR (SYNTHETIC), WHITE PETROLATUM	Carma Laboratories, Inc.	c7a7626c-cf82-4301-af79-c5e85367e777	2025-10-01	Warnings	Exact identifier application number: M017
Viaderma Calm Anti-Itch	HYDROCORTISONE	ViaDerma Distribution, Inc.	7afa2ccd-bfc6-48fc-9a14-a0c6d645844e	2025-10-01	Warnings	Exact identifier application number: M017
AsperFlex Advance	CAMPHOR, MENTHOL, METHYL SALICYLATE	Akron Pharma Inc.	d23d7f2b-4dcd-4c31-9d12-340f233018b4	2025-10-01	Warnings	Exact identifier application number: M017
HEATING PAIN RELIEF	METHYL SALICYLATE, MENTHOL	SUNSET NOVELTIES, INC	4024d604-c8c7-2d73-e063-6294a90a2e80	2025-10-01	Warnings	Exact identifier application number: M017
DR AMIN JAVID Botanical-Complex Pain-Relieving Balm, 30 ml/1.0 fl oz	MENTHOL, CAMPHOR, METHYL SALICYLATE, CAPSICUM OLEORESIN (CONTAINING CAPSAICIN)	BH GLOBAL HOLDINGS LLC	1ddddbb6-2d01-c894-e063-6394a90acd58	2025-10-01	Warnings	Exact identifier application number: M017
Tylenol Precise Pain Relieving Lidocaine 4%	LIDOCAINE	Kenvue Brands LLC	36a95afd-97e5-2271-e063-6394a90aea18	2025-09-30	Warnings	Exact identifier application number: M017
Capsaicin Heat	CAPSAICIN	Universal Distribution Center LLC	b3b40f77-3b0b-4111-968b-f3a87a5701fa	2025-09-29	Warnings	Exact identifier application number: M017
Caring Mills Menthol 4% Roll-On	MENTHOL	Veridian Healthcare	f4308c74-0860-4265-aeaf-a01301cca27a	2025-09-29	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED LARGE	MENTHOL	Universal Distribution Center LLC	d6780230-aa96-4055-b054-be41358568b6	2025-09-29	Warnings	Exact identifier application number: M017
COLD AND HOT MEDICATED	MENTHOL	Universal Distribution Center LLC	c19aa620-401d-43c4-804c-3611cc39e9f2	2025-09-29	Warnings	Exact identifier application number: M017
UniShield First Aid Burn	LIDOCAINE HCL	Unishield	f729c557-da4b-3fb5-e053-6394a90a4196	2025-09-28	Warnings	Exact identifier application number: M017
Xpect Hydrocortisone	HYDROCORTISONE	Cintas Corporation	45ef9be4-54c4-4d85-966b-27708313ded4	2025-09-26	Warnings	Exact identifier application number: M017
Zhuifeng Gao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	3f12da60-26d1-4407-8e02-c3213ea3ad2a	2025-09-26	Warnings	Exact identifier application number: M017
Gutong Tiegao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	5a5c3759-90e0-4a93-99cf-ddbf00aba10d	2025-09-26	Warnings	Exact identifier application number: M017
Zhuanggu Gao Pain Relieving	MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	e3e98530-ce4d-47b9-9383-3088814034eb	2025-09-26	Warnings	Exact identifier application number: M017
GUTONG TIEGAO PAIN RELIEVING	CAMPHOR AND MENTHOL	GUILIN CHINA RESOURCES TIANHE PHARMACEUTICAL CO LTD	3adfac16-ea7b-47df-89f5-91bbd09c4fe1	2025-09-26	Warnings	Exact identifier application number: M017
Xpect Sting Wipes	BENZOCAINE 6%	Cintas Corporation	feeae00d-e266-4ae4-90d2-524da38fa813	2025-09-26	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Walgreens Company	0b4053a8-6c1c-621d-e063-6394a90a4f56	2025-09-25	Warnings	Exact identifier application number: M017
Unishield 1%	HYDROCORTISONE	Unishield	4871a67f-fbb8-4a6b-ace4-d34349028908	2025-09-24	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