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		2026-10-21
excluded package	package	59316-111	59316-111-11	D	Discontinued by firm		2026-10-21

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 54 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
equate hydrocortisone	HYDROCORTISONE	Wal-Mart Stores Inc	70f4636d-4137-498b-ab81-0330de883e53	2025-12-15	Warnings	Exact identifier application number: M017
SALONPAS-HOT CAPSICUM	CAPSAICIN	Hisamitsu Pharmaceutical Co., Inc.	ef5373aa-9857-4d01-95af-2d7716e54ae4	2025-12-15	Warnings	Exact identifier application number: M017
First Aid Burn Cream	FIRST AID BURN CREAM	ProStat First Aid LLC	f70a442e-7ba7-4860-e053-6394a90ac2bd	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease, 3.5g	BURN EASE, 3.5G	ProStat First Aid LLC	004aa18f-3a97-f454-e063-6394a90afcff	2025-12-15	Warnings	Exact identifier application number: M017
PS-3866 Burn Ease, 0.9g	PS-3866 BURN EASE, 0.9G	ProStat First Aid LLC	004d00a5-9cff-29ff-e063-6294a90aeb8c	2025-12-15	Warnings	Exact identifier application number: M017
First Aid Burn Cream	FIRST AID BURN CREAM	ProStat First Aid LLC	0037a1a4-d747-2567-e063-6394a90a721c	2025-12-15	Warnings	Exact identifier application number: M017
PS-3885 Burn Ease, 3.5g	PS-3885 BURN EASE, 3.5G	ProStat First Aid LLC	004c6deb-2844-a0d0-e063-6394a90ae5e4	2025-12-15	Warnings	Exact identifier application number: M017
2677 First Aid Burn Cream	2677 FIRST AID BURN CREAM	ProStat First Aid LLC	ff5bb628-8ef7-4540-e053-6394a90a55ed	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71b98b4-22d0-0124-e053-6394a90ae4cf	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	f71eb4f5-2280-5867-e053-6394a90aac57	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8e6842-c889-d5d3-e063-6394a90af880	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f8c59fb-3622-2bb7-e063-6294a90adc6e	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	Front Line Safety	0e34cb09-d8c6-f8c0-e063-6294a90a0be0	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease 3.5g	BURN EASE 3.5G	Front Line Safety	0f52021f-af8a-5b95-e063-6294a90a2c2a	2025-12-15	Warnings	Exact identifier application number: M017
Burn Ease	BURN EASE	ProStat First Aid LLC	0e25c936-e40a-e23c-e063-6294a90ac0e4	2025-12-15	Warnings	Exact identifier application number: M017
Sting Relief Wipes	STING RELIEF WIPES	ProStat First Aid LLC	0e20252a-5ecb-2526-e063-6294a90a8cde	2025-12-15	Warnings	Exact identifier application number: M017
First Aid Burn Cream	FIRST AID BURN CREAM	Front Line Safety	0f4ce2c2-f306-d95f-e063-6394a90ae7b3	2025-12-15	Warnings	Exact identifier application number: M017
Magsoothium Body	MENTHOL, CAPSAICIN	Ubu/Elements, Inc.	f604d30c-b17c-ec01-e053-2a95a90aa304	2025-12-15	Warnings	Exact identifier application number: M017
Salonpas pain relieving JET	MENTHOL, METHYL SALICYLATE	Hisamitsu Pharmaceutical Co., Inc.	dd1ea3bf-891a-402e-8f43-14302bc9c3e5	2025-12-15	Warnings	Exact identifier application number: M017
Herbal Tendon Bone Relief	CAMPHOR MINT	Guchutang Biotechnology (Longyan) Co., Ltd.	45cf4040-9751-d24b-e063-6294a90aff27	2025-12-13	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