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		2026-10-15
excluded package	package	59316-111	59316-111-11	D	Discontinued by firm		2026-10-15

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 4 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXIMUM STRENGTH Lidocaine Plus Menthol	LIDOCAINE, MENTHOL	ARMY AND AIR FORCE EXCHANGE SERVICE	60f72061-d264-424e-b396-5a609076d352	2026-08-20	Warnings	Exact identifier application number: M017
MENTHOL, CAMPHOR	MENTHOL, CAMPHOR	SUNSET PAIN RELIEF	5980c527-6bcb-a846-e063-6294a90a0788	2026-08-20	Warnings	Exact identifier application number: M017
Pain Relief Patches	CAMPHOR, MENTHOL, METHYL SALICYLATE	Amerisource Bergen	5fb5e5ce-b268-4444-8b63-ea7ea6abf269	2026-08-20	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	58c2b35c-e1ed-7ea8-e063-6294a90a1494	2026-08-19	Warnings	Exact identifier application number: M017
Dr. Scholls Blister Pain Relief Complete Kit	LIDOCAINE	Scholl's Wellness Company LLC	585e740b-e4fa-d2aa-e063-6294a90a0982	2026-08-19	Warnings	Exact identifier application number: M017
Eagle Brand Muscular Balm	MENTHOL, METHYL SALICYLATE	PT. EAGLE INDO PHARMA	0822bcde-a8ad-be95-e063-6294a90ad208	2026-08-19	Warnings	Exact identifier application number: M017
ANTI ITCH	HYDROCORTISONE	HyVee Inc	1ab6bbb8-2b91-4c53-9168-b1e85ac296e9	2026-08-19	Warnings	Exact identifier application number: M017
hydrocortisone 1	HYDROCORTISONE	Kroger Company	f05edff2-2dc5-427c-b52c-518e0aaef4e0	2026-08-19	Warnings	Exact identifier application number: M017
MedPride	HYDROCORTISONE	Shield Line LLC	2f15d3b3-d1e6-4742-9eac-f956c0ffbba4	2026-08-18	Warnings	Exact identifier application number: M017
Pain Relieving Cream Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Garcoa, Inc.	2f736307-5cd4-4a76-9044-4aeecba096cc	2026-08-18	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll on	PAIN RELIEF ROLL ON	NeilMed Pharmaceuticals Inc	58ff9d2d-99e6-8f98-e063-6394a90a8de7	2026-08-17	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1/2%	Sun Pharmaceutical Industries, Inc.	59337940-c9be-58af-e063-6394a90abe13	2026-08-16	Warnings	Exact identifier application number: M017
SIERQ Numbing	MENTHOL	Putian Licheng District Zhijiancheng Trading Co., Ltd.	5936c070-d8e4-56e8-e063-6294a90a5600	2026-08-16	Warnings	Exact identifier application number: M017
Jakwork Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	5911d9b0-1acb-3546-e063-6294a90adb3a	2026-08-15	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	59072f05-eefa-d823-e063-6394a90a0e1a	2026-08-14	Warnings	Exact identifier application number: M017
JJ Care First Aid Burn	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Nantong Health & Beyond Hygienic Products Inc.	c41621fb-c549-4394-a4cb-cb81ef8c98df	2026-08-13	Warnings	Exact identifier application number: M017
JJ Care	HYDROCORTISONE	Nantong Health & Beyond Hygienic Products Inc.	c88fa151-f8a8-4de2-98c9-71319bf53e36	2026-08-13	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	Safetec of America, Inc.	da2b3b2c-11e0-401b-bbd2-d019271d1b3d	2026-08-13	Warnings	Exact identifier application number: M017
CVS Pain Relief Roll-On Lidocaine with Lavender	LIDOCAINE HYDROCHLORIDE	CVS Pharmacy	4aa53176-2103-b47b-e063-6394a90ac735	2026-08-12	Warnings	Exact identifier application number: M017
JUST CBD SOOTHING	MENTHOL, CAMPHOR	Just Brands LLC	5384e80f-c242-76a1-e063-6294a90aba0b	2026-08-12	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