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 25 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LidoTape	LIDOCAINE 4%	V2 Pharma LLC	ed18b4f7-6a2c-4dce-9b53-e485569093c5	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Lidocaine Pain Relief	LIDOCAINE	Veridian Healthcare	4f112ab2-b67a-a3e2-e063-6394a90acb60	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Pain Relief	MENTHOL	Veridian Healthcare	4f11aa1e-de53-a3b0-e063-6294a90a2fe4	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare 2X Medicated Pain Relief	LIDOCAINE, MENTHOL	Veridian Healthcare	4f11fca1-1949-ab8e-e063-6394a90ac627	2026-04-09	Warnings	Exact identifier application number: M017
TheraCare Medicated Pain Relief	CAMPHOR, MENTHOL, METHYL SALICYLATE	Veridian Healthcare	4f125062-af89-40d3-e063-6394a90a27ef	2026-04-09	Warnings	Exact identifier application number: M017
DRMITSUI ECZEMA RELIEF	HYDROCORTISONE 1% ECZEMA RELIEF	Jiangxi Yudexi Pharmaceutical Co., LTD	4eee7637-3a28-e0bd-e063-6294a90ae1a4	2026-04-08	Warnings	Exact identifier application number: M017
SINSIN MULPAS	L-MENTHOL, METHYL SALICYLATE, DL-CAMPHOR	Sinsin Pharmaceutical Co., Ltd.	47c077c2-6e34-8e7a-e063-6294a90a21b5	2026-04-08	Warnings	Exact identifier application number: M017
Yi Tiao Gen Pain Patch	PAIN PATCH	Sheng Chang Pharmaceutical Co, Ltd. Zhongli Factory	4828fe70-f6f8-45e4-9c9a-a9e486dc65e5	2026-04-07	Warnings	Exact identifier application number: M017
Dermatool Nerve Care	LIDOCAINE HCL, MENTHOL	Papalo Group, LLC	4ee40c96-9350-4c68-e063-6294a90ac812	2026-04-07	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	CVS Pharmacy, Inc.	42b3c341-f422-b2b4-e063-6294a90a47b2	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Pain Relieving Topical Analgesic	MENTHOL	Phoenix Bioperformance Products LLC	bb4c9e73-e62d-4b8c-a16c-b90db1a8b2a7	2026-04-06	Warnings	Exact identifier application number: M017
KinetiCream Anti-Inflammatory and Pain Relief	MENTHOL	Phoenix Bioperformance Products LLC	39a6d26b-b5f4-45d7-a9b5-6edbf42d7500	2026-04-06	Warnings	Exact identifier application number: M017
Dr. Blue PainZaway Pain Relieving Roll-On	MENTHOL	Indiana Botanic Gardens	4ecc8241-5a87-2f45-e063-6294a90aa30a	2026-04-06	Warnings	Exact identifier application number: M017
Sunburn Relief Gel	LIDOCAINE HCL	CVS Pharmacy, Inc.	d7f52394-5cc1-48a6-ae89-9fc63b515758	2026-04-06	Warnings, Adverse reactions	Exact identifier application number: M017
Pain-Relieving Patch	CAMPHOR, MENTHOL, METHYL SALICYLATE	CVS Pharmacy	4ecf4a6e-5c0f-7943-e063-6394a90a81cc	2026-04-06	Warnings	Exact identifier application number: M017
RAPID RELIEF	0.025% CAPSAICIN PAIN PATCH	RAPID AID VIET NAM COMPANY LIMITED	4edbaa1a-6e44-4865-e063-6394a90a8cc3	2026-04-06	Warnings	Exact identifier application number: M017
Capsaicin 0.1% Cream	CAPSAICIN 0.1%	Puretek Corporation	4e83441b-cb6a-beb0-e063-6394a90a1b54	2026-04-03	Warnings	Exact identifier application number: M017
NeroCare Capsaicin Neuropathy Relief Cream	CAPSAICIN	Guangzhou Tata Biotechnology Co., Ltd.	4e89b7eb-0d84-dc57-e063-6394a90a7dd9	2026-04-03	Warnings	Exact identifier application number: M017
TheraCare Pain Relief Patch	LIDOCAINE 4%	Veridian Healthcare	4e91da65-8191-6261-e063-6394a90a6bd5	2026-04-03	Warnings	Exact identifier application number: M017
HealthWise Roll-On	LIDOCAINE, MENTHOL	Veridian Healthcare	4e9306b5-949e-f7a9-e063-6394a90ae13a	2026-04-03	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