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 66 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MENTHOL AND METHYL SALICYLATE	ELECTRIC MEDICATED BALM ULTRA STRENGTH	FEI FAH MEDICAL MANUFACTURING PTE LTD	91e6d3b9-25bb-4015-9d96-bd27f93e5ada	2025-11-10	Warnings	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR, MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	bda1e7c1-42df-4126-a512-80f843b07fd0	2025-11-10	Warnings	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEVING	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	9850754b-ac94-4ec6-b75a-8096e5ac9456	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
TONG FENG DING PAIN RELIEF	CAMPHOR AND MENTHOL	Zhejiang Dingtai Pharmaceutical Co., Ltd	fe87b864-b3ee-4a4b-8e5a-e1ee6493de0d	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	5ef90782-8201-47d1-b57f-f032d4c9b06a	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Pain Relieving	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	1388ab3a-c26f-427d-898d-0d88411a5fba	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Solstice Capsaicin Patch Hot	CAPSAICIN	MADISON ONE ACME INC	f74db6e0-853a-4eb3-a4b5-9da2cd3d95cf	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
Lung Choy Shung Pain Relief Liquid	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	4842c6ec-7823-4f6b-afc4-258fce2c2391	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
701 DIEDA ZHENGTONG YAOGAO MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	115041ff-5046-4ca4-b54b-5652037e74bd	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
EXTRA STRENGTH HUA TUO PAIN RELIEF	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	0f269a41-4b56-4e22-b9cb-17d99bf76a57	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
ZANG HONG HUA PAIN RELIEVING	CAMPHOR, CAPSAICIN, AND METHYL SALICYLATE	MADISON ONE ACME INC	e0a8811c-07cf-4dee-a0e5-13b8af1b27b6	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
NECK AND LUMBAR PAIN RELIEVING BALM	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	d06f0650-a5f6-4bc1-a70b-b0fc16968fa9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
SHU JIN HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	ccb6740d-3399-4a2b-ae65-15ca557ba83b	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
GuruNanda Pain Relief	LIDOCAINE HYDROCHLORIDE	GuruNanda, LLC.	3ab6a133-8dca-e14e-e063-6394a90a85e7	2025-11-10	Warnings	Exact identifier application number: M017
HUO LUO PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	65581716-5a2c-4ee8-816d-00caed7b95b4	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
JOSEPHS LION PAIN RELIEVING	CAMPHOR, MENTHOL, METHYL SALICYLATE	MADISON ONE ACME INC	69b88e21-2001-4fb2-b6eb-17f2d6e0ef2e	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
QIAN LI ZHUI FENG PAIN RELIEVING	CAMPHOR, MENTHOL, AND METHYL SALICYLATE	MADISON ONE ACME INC	03a4fb7c-2328-409d-99c8-cbcf2b4a451f	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
WU YANG BRAND PAIN RELIEVING MEDICATED	MENTHOL AND CAMPHOR	MADISON ONE ACME INC	05c6b95a-aeb6-4234-97c7-8d77eccb38d8	2025-11-10	Warnings	Exact identifier application number: M017
HEI GUI PAIN RELIEVING	CAMPHOR AND METHYL SALICYLATE	MADISON ONE ACME INC	4140c404-edab-4923-941d-f74125e943a9	2025-11-10	Warnings, Adverse reactions	Exact identifier application number: M017
E MEI SHAN MEDICATED	CAMPHOR AND MENTHOL	MADISON ONE ACME INC	ddcc814e-fcc4-4232-9ab4-826b8aac35f0	2025-11-10	Warnings, Adverse reactions	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