PERFORM COOL and SOOTHING PAIN RELIEVING

Product NDC: 59316-111
11-digit product format: 593160111
Labeler code: 59316
Product ID: 59316-111_51e0a9b2-bf58-7444-e063-6394a90a3e3a
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Reckitt Benckiser LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-05-18
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 35 mg/mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59316-111	59316-111-10	D	Discontinued by firm		2026-10-16
excluded package	package	59316-111	59316-111-11	D	Discontinued by firm		2026-10-16

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	59316-111-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	59316-111-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-111-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	59316-111-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-111-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	59316-111-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-111-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	59316-111-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-111-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	59316-111-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-111-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	59316-111-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-111-11	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	59316-111-10	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-111-11	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	59316-111-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-111-11	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	59316-111-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-111-11	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	59316-111-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-111-11	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	59316-111-10	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-111-11	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	59316-111-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: PERFORM COOL and SOOTHING PAIN RELIEVING
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	35 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
808955	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
ef158f63-2d75-47a3-b94a-2d821d511863	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59316-111-10	PERFORM COOL and SOOTHING PAIN RELIEVING	3 mL in 1 TUBE	GEL	3	9
59316-111-11	PERFORM COOL and SOOTHING PAIN RELIEVING	30 mL in 1 BOTTLE	GEL	30	9
59316-111-20	PERFORM COOL and SOOTHING PAIN RELIEVING	1 in 1 CARTON	GEL	1	9
59316-111-20	PERFORM COOL and SOOTHING PAIN RELIEVING	118 mL in 1 TUBE	GEL	118	9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ARNICA MONTANA FLOWER	INACTIVE INGREDIENT	OZ0E5Y15PZ	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
EUCALYPTUS OIL	INACTIVE INGREDIENT	2R04ONI662	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
HYPERICUM OIL	INACTIVE INGREDIENT	OZU2FC70HY	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ILEX PARAGUARIENSIS LEAF	INACTIVE INGREDIENT	1Q953B4O4F	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
LAVANDIN OIL	INACTIVE INGREDIENT	9RES347CKG	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
LIME OIL	INACTIVE INGREDIENT	UZH29XGA8G	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
NUTMEG OIL	INACTIVE INGREDIENT	Z1CLM48948	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
PEPPERMINT OIL	INACTIVE INGREDIENT	AV092KU4JH	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
PINE NEEDLE OIL (PINUS SYLVESTRIS)	INACTIVE INGREDIENT	5EXL5H740Y	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
THYME OIL	INACTIVE INGREDIENT	2UK410MY6B	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [PERFORMANCE HEALTH, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59316-111	PERFORM COOL AND SOOTHING PAIN RELIEVING (MENTHOL) GEL [RB HEALTH (US) LLC]	8	Current NDC, Legacy NDC, 4 package rows	20241228_ef158f63-2d75-47a3-b94a-2d821d511863.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 10 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gaayou Numbing	DIBUCAINE HYDROCHLORIDE 0.5% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4c290118-7880-2a98-e063-6294a90a4c03	2026-07-21	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare Pain Relieving Cold Gel	CAMPHOR, MENTHOL	Active and Innovative	572792bb-2819-36c3-e063-6394a90aa504	2026-07-21	Warnings	Exact identifier application number: M017
SYLVIRENE NUMBING	LIDOCAINE 4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a36edc5-5a89-afb5-e063-6294a90a02dd	2026-07-21	Warnings	Exact identifier application number: M017
REINREUDE PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	LIDOCAINE 4% PROVIDES TEMPORARY RELIEF FOR MINOR MUSCLE AND JOINT PAIN	Jiangxi Yudexi Pharmaceutical Co., LTD	4a45c1cb-c5ab-d872-e063-6394a90aab5d	2026-07-21	Warnings	Exact identifier application number: M017
SERYNTH Muscle Comfort	ARNICA MONTANA HPUS 7% MUSCLE COMFORT	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4c10cd-f0c4-8731-e063-6394a90a10a5	2026-07-21	Warnings	Exact identifier application number: M017
DERMFREE MEDICATED LIP	CAMPHOR 2.0% MEDICATED LIP	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4d62fb-8dfa-404a-e063-6294a90a385d	2026-07-21	Warnings	Exact identifier application number: M017
NATUHEAL RELIEF Cream FOR ECZEMA	HYDROCORTISONE ACETATE 1% RELIEF CREAM FOR ECZEMA	Jiangxi Yudexi Pharmaceutical Co., LTD	4c92fed1-a8b4-bda8-e063-6394a90a8a33	2026-07-20	Warnings	Exact identifier application number: M017
REDCOOL Arnica Bruise	ARNICA MONTANA HPUS 7% ARNICA BRUISE	Jiangxi Zhongletang Pharmaceuticals Co.,Ltd.	49911392-e55e-1a6b-e063-6394a90a9af0	2026-07-20	Warnings	Exact identifier application number: M017
Vamy HEMORRHOID	LIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	499197aa-f872-3abf-e063-6294a90aeda2	2026-07-20	Warnings	Exact identifier application number: M017
Subleef NUMBING	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4a201a6b-adde-c0a8-e063-6394a90a8285	2026-07-20	Warnings	Exact identifier application number: M017
PUVIDA NUMBING	MENTHOL 5% (W/W) NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4de4e317-2f4f-e5d6-e063-6394a90a0611	2026-07-20	Warnings	Exact identifier application number: M017
Careland Lidocaine Plus Menthol Pain Relieving Gel Patches	LIDOCAINE, MENTHOL	Planet (Anhui) Pharmaceutical Co., Ltd.	8b607c03-a98f-445a-a69e-7625a76ac44b	2026-07-20	Warnings	Exact identifier application number: M017
Yodo Salil	OINTMENT	Laboratorio Neo Farmaco del Ecuador Neofarmaco Cia. LTDA.	56812625-7eab-6a25-e063-6294a90a23fe	2026-07-20	Warnings	Exact identifier application number: M017
VBBV Numbing	LIDOCAINE	Jiashen International Trade Limited	5716c36b-6e97-c294-e063-6394a90aaf5c	2026-07-20	Warnings	Exact identifier application number: M017
Burn Relief	LIDOCAINE	Premier Brands of America Inc.	560c29cc-2453-5d14-e063-6394a90a844f	2026-07-17	Warnings	Exact identifier application number: M017
4% Lidocaine Pain Relief Patch	LIDOCAINE 4%	Guangxi Keyun E-commerce Co., Ltd.	4981e9c3-2a19-aed8-e063-6294a90af216	2026-07-17	Warnings	Exact identifier application number: M017
endurance wipe	BENZOCAINE	Absorption Pharmaceuticals, LLC	303db1de-94fc-4543-e063-6294a90a01b9	2026-07-17	Warnings	Exact identifier application number: M017
Professional Therapy MuscleCare pain relieving gel Extra Strength	CAMPHOR, MENTHOL	Active and Innovative Inc.	56d30c33-ef5a-c63d-e063-6294a90acd29	2026-07-17	Warnings	Exact identifier application number: M017
Mineral Ice Extreme Gel Alpine Fresh Scent	MENTHOL	Carlin Consumer Health LLC	56d3ca3d-21e1-a40a-e063-6294a90a9ff4	2026-07-17	Warnings	Exact identifier application number: M017
DRAVYNOR TOPICAL ANALGESIC HEAT Patch	MENTHOL 24MG CAPSAICIN 16MG TOPICAL ANALGESIC HEAT PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	56b83ee8-8d86-9436-e063-6294a90a0c25	2026-07-16	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
808955	menthol 3.5 % Topical Gel	PSN	ef158f63-2d75-47a3-b94a-2d821d511863	9
808955	menthol 0.035 MG/MG Topical Gel	SCD	ef158f63-2d75-47a3-b94a-2d821d511863	9
808955	menthol 3.5 % Topical Gel	SY	ef158f63-2d75-47a3-b94a-2d821d511863	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59316-111-10	59316011110	3 mL in 1 TUBE (59316-111-10)	3 ml	2015-05-18	2023-12-31	No	No	Current
59316-111-11	59316011111	30 mL in 1 BOTTLE (59316-111-11)	30 ml	2015-05-18	2023-12-31	No	No	Current
59316-111-20	59316011120	1 TUBE in 1 CARTON (59316-111-20) / 118 mL in 1 TUBE	1 tube	2015-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PERFORM ® COOL and SOOTHING PAIN RELIEVING	Reckitt Benckiser LLC	2026-05-15	HUMAN OTC DRUG LABEL	9