XOLIDO

Product NDC
76420-451
11-digit product format
764200451
Labeler code
76420
Product ID
76420-451_ead450b0-177a-2b5f-e053-2995a90a6572
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-05
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
4 g/mL
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 productproduct76420-451DDiscontinued by firm2026-10-05
excluded packagepackage76420-45176420-451-01DDiscontinued 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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76420-451-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76420-451-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76420-451-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76420-451-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76420-451-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76420-451-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76420-451-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76420-451-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76420-451-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76420-451-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76420-451-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76420-451-01557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-451-01ML - Milliliter76420-4518d0ed636-eb28-4453-9aab-44cabec4816012014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41AXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
LIDOCAINEACTIVE MOIETY98PI200987XOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70XOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4XOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
HELIANTHUS ANNUUS FLOWERING TOPINACTIVE INGREDIENTBKJ0J3D1BPXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
LAURETH-7INACTIVE INGREDIENTZ95S6G8201XOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1
WATERINACTIVE INGREDIENT059QF0KO0RXOLIDO (LIDOCAINE HCL) CREAM [ENOVACHEM MANUFACTURING]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-451-0176420045101118 mL in 1 BOTTLE (76420-451-01) 118 ml2013-04-050000-00-00NoNoCurrent