Quality Choice Ultra Strength Pain Relieving Cream

Product NDC
63868-692
Requested package NDC
63868-692-04
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-69263868-692-04IInactivated by FDA2026-10-05

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63868-69263868-692-04IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63868-69263868-692-04IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…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
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-692-042025-07-29C16284748780-13b156c62-3465-fb37-e063-e6dba90a4e07Quality Choice Ultra Strength Pain Relieving Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-692-04Quality Choice Ultra Strength Pain Relieving CreamUltra Strength1 in 1 CARTONCREAM12
63868-692-04Quality Choice Ultra Strength Pain Relieving CreamUltra Strength113 g in 1 TUBECREAM1132

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-692-04GM - Gram63868-692da4685f6-88f7-4e71-bacf-936f90192c7712021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-692QUALITY CHOICE ULTRA STRENGTH PAIN RELIEVING CREAM ULTRA STRENGTH (CAMPHOR, MENTHOL, METHYL SALICYLATE) CREAM [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]2Legacy NDC, 2 package rows20241220_be62b6ea-09ac-0d4b-e053-2a95a90ada65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamPSNbe62b6ea-09ac-0d4b-e053-2a95a90ada652
283083camphor 40 MG/ML / menthol 100 MG/ML / methyl salicylate 300 MG/ML Topical CreamSCDbe62b6ea-09ac-0d4b-e053-2a95a90ada652
283083camphor 4 % / menthol 10 % / methyl salicylate 30 % Topical CreamSYbe62b6ea-09ac-0d4b-e053-2a95a90ada652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-692-04638680692041 TUBE in 1 CARTON (63868-692-04) > 113 g in 1 TUBE1 tube2021-03-010000-00-00NoNoCurrent