TopCare Pain Relieving Roll-On

Product NDC: 36800-290
11-digit product format: 368000290
Labeler code: 36800
Product ID: 36800-290_d6e69347-6255-4460-97e1-754359314327
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL, UNSPECIFIED FORM
Dosage form: GEL
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-09-03
Substance: MENTHOL, UNSPECIFIED FORM
Active strength: 40 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	36800-290-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	36800-290-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	36800-290-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	36800-290-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	36800-290-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	36800-290-01	`1332a3947898…`	`d4bfe170f9cd…`

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: TopCare Pain Relieving Roll-On
Brand name suffix: Topical Analgesic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL, UNSPECIFIED FORM	40 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
415974	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
48589893-ca67-471d-88bc-92014295ab9f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
36800-290-01	2024-11-13	C162847	48780-1	f386c64a-2164-0266-e053-dadaa90a7c1a	TopCare Pain Relieving Roll-On Gel Topical Analgesic
36800-290-01	2023-01-30	C162847	48780-1	f386c64a-2164-0266-e053-dadaa90a7c1a	TopCare Pain Relieving Roll-On Gel Topical Analgesic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-290-01	TopCare Pain Relieving Roll-OnTopical Analgesic	74 mL in 1 BOTTLE, WITH APPLICATOR	GEL	74		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-290	TOPCARE PAIN RELIEVING ROLL-ON TOPICAL ANALGESIC (MENTHOL, UNSPECIFIED FORM) GEL [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 1 package rows	20241115_48589893-ca67-471d-88bc-92014295ab9f.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 129 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Relief	MENTHOL	La Mend, Inc.	1f92de3a-7180-5884-e063-6294a90aebf5	2024-08-01	Warnings	Exact identifier application number: M017
Meijer Medicated Foot Powder	MENTHOL	Meijer Distribution	07ec6c20-73c4-e5e4-e063-6294a90a7e55	2024-07-29	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	e05ec3b7-e9ab-4eaa-8518-86304336697c	2024-07-29	Warnings	Exact identifier application number: M017
Walgreens Roll-On	CAPSAISIN 0.1%	Walgreens Co	1e65bf31-15c7-5e6a-e063-6394a90ac956	2024-07-29	Warnings	Exact identifier application number: M017
Camphotrex	CAMPHOR, MENTHOL	PureTek Corporation	3b6c6eef-e92d-497d-afe8-82356637c2b8	2024-07-26	Warnings	Exact identifier application number: M017
Camphotrol	CAMPHOR, MENTHOL	PureTek Corporation	ccac9f37-a374-4765-e053-2a95a90ad2f7	2024-07-26	Warnings	Exact identifier application number: M017
Real Time Pain Relief Foot	MENTHOL	Real Time Products Inc.	29c8e06d-9b29-44f9-ac21-9160d06475cb	2024-07-24	Warnings	Exact identifier application number: M017
Capsaicin 0.075 Percent	CAPSAICIN	Alexso, Inc	33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	2024-07-22	Warnings	Exact identifier application number: M017
TIDL Pain Relief CRYO Therapy Limited Edition	PAIN RELIEF CRYO THERAPY LIMITED EDITION	Shenzhen Sam Technology Co., Ltd.	1d966b67-fd9c-eab6-e063-6294a90aa75e	2024-07-19	Warnings	Exact identifier application number: M017
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier application number: M017
Ultra Balm	MENTHOL AND METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	de997baf-aa04-474e-b912-3fc67e720d0b	2024-07-19	Warnings	Exact identifier application number: M017
Ling Nam Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	3f16cce3-366f-41f3-8829-6de4082a8c19	2024-07-19	Warnings	Exact identifier application number: M017
Koong Yick Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	bc33e185-3b42-98b5-e053-2995a90a6308	2024-07-18	Warnings	Exact identifier application number: M017
Koong Yick Hung Fa	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	9c8a121d-6da2-4435-a2d7-a0b71d10740d	2024-07-18	Warnings	Exact identifier application number: M017
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	Warnings	Exact identifier application number: M017
Tidl Pain Relief Evening Therapy Spray.	PAIN RELIEF EVENING THERAPY SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a2f4a-7b25-e595-e063-6394a90a00d5	2024-07-13	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
415974	menthol 4 % Topical Gel	PSN	48589893-ca67-471d-88bc-92014295ab9f	4
415974	menthol 0.04 MG/MG Topical Gel	SCD	48589893-ca67-471d-88bc-92014295ab9f	4
415974	menthol 4 % Topical Gel	SY	48589893-ca67-471d-88bc-92014295ab9f	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-290-01	36800029001	74 mL in 1 BOTTLE, WITH APPLICATOR (36800-290-01)	74 ml	2020-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare Pain Relieving Roll-On Gel Topical Analgesic	Topco Associates LLC \| Garcoa, Inc. \| SV Labs Toronto Corporation	2024-11-13	HUMAN OTC DRUG LABEL	4