Quality Choice Ultra Strength Pain Relieving Cream

Product NDC: 63868-692
11-digit product format: 638680692
Labeler code: 63868
Product ID: 63868-692_be62bd1e-5a06-f775-e053-2995a90aba63
Type: HUMAN OTC DRUG
Nonproprietary name: camphor, menthol, methyl salicylate
Dosage form: CREAM
Route: TOPICAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: part348
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-01
Marketing end: 0000-00-00
Substance: CAMPHOR (NATURAL); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE
Active strength: 40 mg/g; mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63868-692		I	Inactivated by FDA		2026-10-05
excluded package	package	63868-692	63868-692-04	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 · 4 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63868-692-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	63868-692-04	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63868-692-04	2025-07-29	C162847	48780-1	3b156c62-3465-fb37-e063-e6dba90a4e07	Quality Choice Ultra Strength Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-692-04	Quality Choice Ultra Strength Pain Relieving CreamUltra Strength	1 in 1 CARTON	CREAM	1		2
63868-692-04	Quality Choice Ultra Strength Pain Relieving CreamUltra Strength	113 g in 1 TUBE	CREAM	113		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-692-04	GM - Gram	63868-692	da4685f6-88f7-4e71-bacf-936f90192c77	1	2021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-692	QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	2	Legacy NDC, 2 package rows	20241220_be62b6ea-09ac-0d4b-e053-2a95a90ada65.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N20HL7Q941	CAMPHOR (NATURAL)	464-49-3	CAMPHOR (NATURAL)
L7T10EIP3A	MENTHOL, UNSPECIFIED FORM	1490-04-6	MENTHOL, UNSPECIFIED FORM
LAV5U5022Y	METHYL SALICYLATE	119-36-8	METHYL SALICYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
283083	camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream	PSN	be62b6ea-09ac-0d4b-e053-2a95a90ada65	2
283083	camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical Cream	SCD	be62b6ea-09ac-0d4b-e053-2a95a90ada65	2
283083	camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical Cream	SY	be62b6ea-09ac-0d4b-e053-2a95a90ada65	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-692-04	63868069204	1 TUBE in 1 CARTON (63868-692-04) > 113 g in 1 TUBE	1 tube	2021-03-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Choice Ultra Strength Pain Relieving Cream	QUALITY CHOICE (Chain Drug Marketing Association) \| ANICARE PHARMACEUTICALS PRIVATE LIMITED	2024-12-18	HUMAN OTC DRUG LABEL	2