DZUL - LIDO CREME

Product NDC
83037-423
Requested package NDC
83037-423-02
11-digit product format
830370423
Labeler code
83037
Product ID
83037-423_eb3e4e19-2b12-c87f-e053-2995a90a2c5e
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, MENTHOL
Dosage form
LOTION
Route
TOPICAL
Labeler
Caball Sales, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-17
Marketing end
0000-00-00
Substance
LIDOCAINE; MENTHOL
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 packagepackage83037-42383037-423-02DDiscontinued by firm2026-10-05

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 packagepackage83037-42383037-423-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83037-42383037-423-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83037-423-028303704230271 g in 1 BOTTLE, WITH APPLICATOR (83037-423-02) 71 g2022-10-170000-00-00NoNoCurrent