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		2026-10-23
excluded package	package	59316-111	59316-111-11	D	Discontinued by firm		2026-10-23

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 58 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alocane Max	LIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDE	Quest Products LLC	0a35221a-2fcb-2735-e063-6294a90a88ca	2025-12-04	Warnings	Exact identifier application number: M017
Pain Relieving	TROLAMINE SALICYLATE	CARDINAL HEALTH 110, LLC. DBA LEADER	b813262e-57c6-4d2c-8cc0-7a17f6f59343	2025-12-04	Warnings	Exact identifier application number: M017
Gold Bond Medicated Extra Strength Body	MENTHOL	Gold Bond Co LLC	7b75b7de-9c0b-4edf-b923-320f7d2bb1e6	2025-12-04	Warnings	Exact identifier application number: M017
Lidocaine Patch	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	38767081-7011-6602-e063-6394a90a2784	2025-12-03	Warnings	Exact identifier application number: M017
4% Lidocaine Maximum Strength Pain Relief	LIDOCAINE	Shenzhen Finona Information Technology Co., Ltd	3e5a5165-a773-0501-e063-6294a90ae2f4	2025-12-03	Warnings	Exact identifier application number: M017
Leader Lidocaine	LIDOCAINE HCL	CARDINAL HEALTH	cece6765-0e2f-5ce9-e053-2995a90a3758	2025-12-03	Warnings	Exact identifier application number: M017
Westlake Lidocaine	LIDOCAINE HCL	Westlake Pharma LLC	0c586a14-1a2a-9f42-e063-6294a90a16c1	2025-12-03	Warnings	Exact identifier application number: M017
CVS Lidocaine Maximum Strength	LIDOCAINE HCL	CVS Pharmacy	87490c0f-a4d9-740e-e053-2a95a90a4724	2025-12-03	Warnings	Exact identifier application number: M017
CVS Maximum Strength Burn	LIDOCAINE HYDROCHLORIDE 4%	CVS Pharmacy	4510f379-c5a4-92c3-e063-6294a90a0a32	2025-12-03	Warnings	Exact identifier application number: M017
LidoPatch Pain Relief	LIDOCAINE, MENTHOL	JAR Laboratories	07289aa1-43ed-df31-e063-6394a90a764a	2025-12-03	Warnings	Exact identifier application number: M017
Equate Pain Relief Cream	4% LIDOCAINE HCL	Walmart, Inc	7d8e8a9a-5474-4c7b-e053-2991aa0a29f5	2025-12-03	Warnings	Exact identifier application number: M017
Solarcaine Burn Pain Relief 4oz	SOLARCAINE BURN PAIN RELIEF 4OZ	WellSpring Pharmaceutical Corporation	14f23c28-c713-4868-9f46-66363bf94b2c	2025-12-03	Warnings	Exact identifier application number: M017
ElixirCortiRelief	HYDROCORTISONE	ELIXIR HEALTHCARE USA, LLC.	a6ca66f3-9759-4c98-a758-45700bc08352	2025-12-02	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE 4%	Trifecta Pharmaceuticals USA, LLC.	12a27ce7-c547-7134-e063-6394a90a94bd	2025-12-02	Warnings	Exact identifier application number: M017
5Kind DMSO	MENTHOL, METHYL SALICYLATE	5KIND TRADING LTD	6a6c7241-f544-4784-9581-f5b172fdbec7	2025-12-02	Warnings	Exact identifier application number: M017
PEDIADERMICS ECZEMA 2	HYDROCORTISONE	RENU LABORATORIES, LLC	da840bf6-ed65-bafc-e053-2a95a90a92d5	2025-12-02	Warnings	Exact identifier application number: M017
Thera Plus Maximum Strength Hydrocortisone	HYDROCORTISONE	Fourstar Group USA, Inc	7d4e21d1-2914-4690-9084-a52abeab0958	2025-12-02	Warnings	Exact identifier application number: M017
Rugby Capsaicin Cream	CAPSAICIN	Rugby Laboratories	9eca34f1-e91a-3ac1-e053-2a95a90a9bd9	2025-12-02	Warnings	Exact identifier application number: M017
Leader Capsaicin Pain Relief Cream	CAPSAICIN	Cardinal Health 110 dba LEADER	a5620709-0fed-4979-e053-2a95a90ac654	2025-12-02	Warnings	Exact identifier application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)	HYDROCORTISONE ACETATE	Sun Pharmaceutical Industries, Inc.	9f0b09e7-6cfd-4fd6-8631-67799edf4e08	2025-12-02	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