FDA.reportPublic FDA data

Lidocaine HCl

Product NDC
59088-997
Requested package NDC
59088-997-03
11-digit product format
590880997
Labeler code
59088
Product ID
59088-997_d5b00129-67ae-4003-8c9b-06b79fd1296b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-13
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
30 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage59088-99759088-997-03DDiscontinued by firm2026-10-15

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 packagepackage59088-99759088-997-03DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage59088-99759088-997-03DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
59088-997-03GM - Gram59088-99799ae8ec5-64a1-4644-9ba9-950d4a9b518012012-07-24
59088-997-07GM - Gram59088-997d847af1e-8ffa-408b-81d9-4e3eb788c32412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
ALUMINUM SULFATEINACTIVE INGREDIENT34S289N54ELIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HCL (LIDOCAINE HCL ) CREAM [PURETEK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-997LIDOCAINE HCL CREAM [PURETEK CORPORATION]3Legacy NDC20250131_ac3beb5a-52c6-42d5-9f90-74a3724b48fe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-997-03590880997031 TUBE in 1 CARTON (59088-997-03) > 28.3 g in 1 TUBE1 tube2011-06-130000-00-00NoNoCurrent