Medicated Pain Relief Patches

Product NDC: 63868-124
Requested package NDC: 63868-124-20
11-digit product format: 638680124
Labeler code: 63868
Product ID: 63868-124_1289a099-6246-435f-8545-7084a73600e0
Type: HUMAN OTC DRUG
Nonproprietary name: CAMPHOR, MENTHOL, METHYL SALICYLATE
Dosage form: PATCH
Route: TOPICAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: CAMPHOR (SYNTHETIC); MENTHOL; METHYL SALICYLATE
Active strength: 3 g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63868-124	63868-124-20	I	Inactivated by FDA		2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-124-20	2025-01-30	C162847	48780-1	2cef2736-8ca1-d83d-e063-dadaa90ab31f	QUALITY CHOICE Medicated Pain Relief Patches
63868-124-60	2025-01-30	C162847	48780-1	2cef2736-8ca1-d83d-e063-dadaa90ab31f	QUALITY CHOICE Medicated Pain Relief Patches

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63868-124-20	Medicated Pain Relief Patches	20 in 1 BOX	PATCH	20	2
63868-124-20	Medicated Pain Relief Patches	9 g in 1 PATCH	PATCH	9	2
63868-124-60	Medicated Pain Relief Patches	60 in 1 BOX	PATCH	60	2
63868-124-60	Medicated Pain Relief Patches	9 g in 1 PATCH	PATCH	9	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-124-60	EA - Each	63868-124	1e3b001c-8984-4e2d-870c-65ef47d595fd	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-124	MEDICATED PAIN RELIEF PATCHES (CAMPHOR, MENTHOL, METHYL SALICYLATE) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2	Legacy NDC, 4 package rows	20200225_08bf26f5-8fbd-44b9-9f79-5044ba71eb70.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5TJD82A1ET	CAMPHOR (SYNTHETIC)	76-22-2	CAMPHOR (SYNTHETIC)
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1793147	camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated Patch	PSN	08bf26f5-8fbd-44b9-9f79-5044ba71eb70	2
1793147	camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated Patch	SCD	08bf26f5-8fbd-44b9-9f79-5044ba71eb70	2
1793147	camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated Patch	SY	08bf26f5-8fbd-44b9-9f79-5044ba71eb70	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-124-20	63868012420	20 PATCH in 1 BOX (63868-124-20) > 9 g in 1 PATCH	20 patch	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
QUALITY CHOICE Medicated Pain Relief Patches	QUALITY CHOICE (Chain Drug Marketing Association) \| Foshan Aqua Gel Biotech Co.,Ltd.	2017-09-14	HUMAN OTC DRUG LABEL	2