FDA.reportPublic FDA data

QUALITY CHOICE PAIN RELIEF PATCHES

Product NDC
63868-309
11-digit product format
638680309
Labeler code
63868
Product ID
63868-309_c961b5cd-dbd9-da07-e053-2995a90af70a
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
PATCH
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-07-01
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
4 g/100g
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-309IInactivated by FDA2026-10-05
excluded packagepackage63868-30963868-309-06IInactivated 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage63868-309-06e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63868-309-069bebd1f3094a…5416666fcb17…

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 conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-309-062021-08-13C16284748780-19d75b9d0-e45e-f424-e053-dadaa90a57ceQUALITY CHOICE PAIN RELIEF PATCHES
63868-309-062020-01-31C16284748780-19d75b9d0-e45e-f424-e053-dadaa90a57ceQUALITY CHOICE PAIN RELIEF PATCHES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-309-06QUALITY CHOICE PAIN RELIEF PATCHES9 g in 1 PATCHPATCH93
63868-309-06QUALITY CHOICE PAIN RELIEF PATCHES5 in 1 CARTONPATCH53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-309-06EA - Each63868-3094d2f47b3-169a-4a7b-834a-e7b74e9f282812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-309QUALITY CHOICE PAIN RELIEF PATCHES (LIDOCAINE) PATCH [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC, 2 package rows20241220_8fa68592-7586-494b-a74e-4f6f42bc73ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSN8fa68592-7586-494b-a74e-4f6f42bc73ce3
1737778lidocaine 0.04 MG/MG Medicated PatchSCD8fa68592-7586-494b-a74e-4f6f42bc73ce3
1737778lidocaine 4 % Medicated PatchSY8fa68592-7586-494b-a74e-4f6f42bc73ce3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-309-06638680309065 PATCH in 1 CARTON (63868-309-06) > 9 g in 1 PATCH5 patch2017-07-010000-00-00NoNoCurrent