FDA.reportPublic FDA data

Lidocaine plus Menthol

Product NDC
68016-876
Requested package NDC
68016-876-05
11-digit product format
680160876
Labeler code
68016
Product ID
68016-876_eff82087-75ce-30a3-e053-2a95a90a1bc0
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Chain Drug Consortium, LLC
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-01-14
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
4 g/100g; 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 packagepackage68016-87668016-876-05IInactivated 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 packagepackage68016-87668016-876-05IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68016-87668016-876-05IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68016-87668016-876-05IInactivated 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
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
68016-876-052022-12-16C16284748780-1d6a99b39-9e13-a426-e053-dadaa90af4c2Lidocaine Plus Menthol
68016-876-052022-01-28C16284748780-1d6a99b39-9e13-a426-e053-dadaa90af4c2Lidocaine Plus Menthol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-876-05Lidocaine plus Menthol8 g in 1 PATCHPATCH83
68016-876-05Lidocaine plus Menthol5 in 1 POUCHPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-876LIDOCAINE PLUS MENTHOL (LIDOCAINE, MENTHOL) PATCH [CHAIN DRUG CONSORTIUM, LLC]3Legacy NDC, 2 package rows20241222_1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249758lidocaine 4 % / menthol 1 % Medicated PatchPSN1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f03
1249758lidocaine 0.04 MG/MG / menthol 0.01 MG/MG Medicated PatchSCD1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f03
1249758lidocaine 4 % / menthol 1 % Medicated PatchSY1d1ecb6f-9447-45d0-8a1f-d5e17efbf0f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-876-05680160876055 PATCH in 1 POUCH (68016-876-05) > 8 g in 1 PATCH5 patch2019-01-140000-00-00NoNoCurrent