PREMIER VALUE PAIN RELIEF PATCHES

Product NDC
68016-066
Requested package NDC
68016-066-05
11-digit product format
680160066
Labeler code
68016
Product ID
68016-066_eff7fe94-3ca6-3965-e053-2995a90a56a3
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE
Dosage form
PATCH
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
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
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage68016-06668016-066-05IInactivated 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 · 3 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
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68016-06668016-066-05IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-06668016-066-05IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-06668016-066-05IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-066-052022-12-16C16284748780-1d6a99b39-6a03-a426-e053-dadaa90af4c2PREMIER VALUE PAIN RELIEF PATCHES
68016-066-052022-01-28C16284748780-1d6a99b39-6a03-a426-e053-dadaa90af4c2PREMIER VALUE PAIN RELIEF PATCHES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-066-05PREMIER VALUE PAIN RELIEF PATCHES9 g in 1 PATCHPATCH94
68016-066-05PREMIER VALUE PAIN RELIEF PATCHES5 in 1 CARTONPATCH54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-066-05EA - Each68016-066de563084-1479-40c8-80dc-9f39924fad4a12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-066PREMIER VALUE PAIN RELIEF PATCHES (LIDOCAINE) PATCH [CHAIN DRUG CONSORTIUM, LLC]4Legacy NDC, 2 package rows20241222_c1937047-98e4-4d88-a2c7-ffb6fc803376.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1737778lidocaine 4 % Medicated PatchPSNc1937047-98e4-4d88-a2c7-ffb6fc8033764
1737778lidocaine 0.04 MG/MG Medicated PatchSCDc1937047-98e4-4d88-a2c7-ffb6fc8033764
1737778lidocaine 4 % Medicated PatchSYc1937047-98e4-4d88-a2c7-ffb6fc8033764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-066-05680160066055 PATCH in 1 CARTON (68016-066-05) > 9 g in 1 PATCH5 patch2017-07-010000-00-00NoNoCurrent