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 63 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4x Medicated Toothache and Gum Cream	BENZOCAINE	Kroger	a8c5090a-24f9-4e73-e053-2a95a90acca0	2025-11-14	Warnings	Exact identifier application number: M017
PM Toothache Relief	BENZOCAINE	CVS	0a5a8cd0-d680-8a0f-e063-6294a90aa65c	2025-11-14	Warnings	Exact identifier application number: M017
PM Toothache Relief	BENZOCAINE	Walgreens	e816f742-fba9-3c12-e053-2a95a90a192f	2025-11-14	Warnings	Exact identifier application number: M017
4x Medicated Toothache and Gum Cream	BENZOCAINE	Walgreens	a71c2092-4ece-b82e-e053-2995a90ac933	2025-11-14	Warnings	Exact identifier application number: M017
After Bite Outdoor	DIPHENHYDRAMINE HCL	Tender Corporation d/b/a Adventure Ready Brands	22b891a9-6386-dee1-e063-6394a90a5c2f	2025-11-14	Warnings	Exact identifier application number: M017
QR PAIN	ANALGESIC	MARYHELENE ENTERPRISES INC	8f8f53e3-fe31-e7b5-e053-2995a90a710d	2025-11-14	Warnings	Exact identifier application number: M017
QR PAIN	ANALGESIC	MARYHELENE ENTERPRISES INC	9984a510-30be-4013-e053-2995a90a841e	2025-11-14	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Kroger	3f881349-fcdd-e276-e063-6394a90ae49e	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	434cb8b2-a996-5360-e063-6394a90ada03	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	COLD RELIEF PATCH 5% MENTHOL	RAPID AID VIET NAM COMPANY LIMITED	4360e3ec-7a4b-b28e-e063-6294a90a0bd6	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH CAMPHOR 110MG MENTHOL 33MG CAPSICUM EXTRACT 22MG	RAPID AID VIET NAM COMPANY LIMITED	4360e3be-0ec4-cd57-e063-6394a90aca63	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PAIN RELIEF PATCH LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	43616ad7-58bb-e5ad-e063-6394a90a192b	2025-11-13	Warnings	Exact identifier application number: M017
4x Medicated Severe Toothache and Gum Gel	BENZALKONIUM CHLORIDE	Meijer	97ce7890-5093-1763-e053-2a95a90afae7	2025-11-13	Warnings	Exact identifier application number: M017
Pain Reliever	CAMPHOR, MENTHOL	Kool 'N Fit Inc.	2253f6bd-5707-b993-e063-6394a90aa74a	2025-11-13	Warnings	Exact identifier application number: M017
Rapid Relief	PLANTAR FASCIITIS PAIN RELIEF LIDOCAINE 4% MENTHOL 1%	RAPID AID VIET NAM COMPANY LIMITED	4360e0d1-46cd-ab4b-e063-6394a90a55e1	2025-11-12	Warnings	Exact identifier application number: M017
CVS Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	CVS	8723e097-296f-784a-e053-2991aa0a552e	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	154d8821-3e76-b0e2-e063-6294a90ae077	2025-11-12	Warnings	Exact identifier application number: M017
Good neighbor Pharmacy Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	AMERISOURCEBERGEN DRUG CORPORATION	87395273-380c-7cef-e053-2991aa0a54c6	2025-11-12	Warnings	Exact identifier application number: M017
Quality Choice Itch Relief	DIPHENHYDRAMINE HCL, ZINC ACETATE	Chain Drug Marketing Association	8735b298-83f3-0b5d-e053-2a91aa0a8292	2025-11-12	Warnings	Exact identifier application number: M017
Dragon Pain Relieving Balm	CAMPHOR, MENTHOL	Americanna Wellness, Inc.	1550e794-b3c0-4769-e063-6294a90a8c2d	2025-11-12	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
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