FDA.reportPublic FDA data

Lidocaine

Product NDC
69903-005
11-digit product format
699030005
Labeler code
69903
Product ID
69903-005_ece604f4-d2be-d484-e053-2a95a90ac10f
Type
HUMAN OTC DRUG
Nonproprietary name
Maximum Strength Pain Reliever
Dosage form
CREAM
Route
TOPICAL
Labeler
Shinpharma Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-10-19
Marketing end
0000-00-00
Substance
LIDOCAINE
Active strength
5 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69903-005IInactivated by FDA2026-10-05
excluded packagepackage69903-00569903-005-05IInactivated 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 · 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
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct69903-005IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage69903-00569903-005-05IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…

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
69903-005-052024-04-03C16284748780-11030e365-59b8-111a-e063-dadaa90a10e2Dr. Numb Maximum Strength Pain Reliever
69903-005-052024-01-30C16284748780-11030e365-59b8-111a-e063-dadaa90a10e2Dr. Numb Maximum Strength Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69903-005-05Lidocaine50 g in 1 TUBECREAM503
69903-005-05Lidocaine1 in 1 BOXCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69903-005LIDOCAINE (MAXIMUM STRENGTH PAIN RELIEVER) CREAM [SHINPHARMA INC]3Legacy NDC, 2 package rows20240405_cebc631c-b616-469e-e053-2995a90a6f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1534792lidocaine 5 % Topical CreamPSNcebc631c-b616-469e-e053-2995a90a6f743
1534792lidocaine 50 MG/ML Topical CreamSCDcebc631c-b616-469e-e053-2995a90a6f743
1534792lidocaine 5 % Topical CreamSYcebc631c-b616-469e-e053-2995a90a6f743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69903-005-05699030005051 TUBE in 1 BOX (69903-005-05) > 50 g in 1 TUBE1 tube2021-10-190000-00-00NoNoCurrent