FDA.reportPublic FDA data

NDC 59088-771-01 - Lidocaine HCl 3% and Hydrocortisone Acetate1% Cream

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
59088-771
Requested NDC
59088-771-01
Package NDCs from labels
59088-771-01, 59088-771-20, 59088-771-07
Manufacturer
PureTek Corporation
Effective date
2025-06-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Lidocaine HCl 3% and Hydrocortisone Acetate1% Cream - PureTek CorporationPureTek Corporation2025-06-11HUMAN PRESCRIPTION DRUG LABEL
Lidocaine HCl - Hydrocortisone Acetate - PureTek CorporationPureTek Corporation2025-01-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-771-01Lidocaine HCl - Hydrocortisone Acetate7 g in 1 TUBECREAM73
59088-771-07Lidocaine HCl - Hydrocortisone Acetate7 g in 1 TUBECREAM73
59088-771-20Lidocaine HCl - Hydrocortisone Acetate20 in 1 KITCREAM203
59088-771-01Lidocaine HCl 3% and Hydrocortisone Acetate1% Cream7 g in 1 TUBECREAM20 g in 710 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-771LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]3Current NDC, Legacy NDC, 3 package rows20250131_f3b75de3-c9e6-4ecc-a286-5b279403911d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-771-20EA - Each59088-771a4435fdf-f3c5-48c7-a4b1-f30724cb3d6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
ALUMINUM SULFATEINACTIVE INGREDIENT34S289N54ELIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
CARBOMER 934INACTIVE INGREDIENTZ135WT9208LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 92 · 1,830 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProCure HydroShieldPETROLATUM 44.28%Twin Med LLC3ab7bfb2-bbcf-0822-e063-6294a90af0842026-08-03WarningsExact identifier
unii: 4T6H12BN9U
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEMedical Purchasing Solutions, LLC46404c7b-2ea4-e47b-e063-6294a90a779f2026-08-03Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
unii: T5L8T28FGP
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dentalc5cc87df-df3f-42b8-af84-5f2045d420842026-07-30Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Aspercreme Lidocaine No-Mess plus LavenderLIDOCAINE HCLChattem, Inc.3948a3d2-ce04-4703-8709-211e75c9c38d2026-07-29WarningsExact identifier
unii: V13007Z41A
Aspercreme Professional CreamLIDOCAINE HCL 4%Chattem, Inc.ef297864-5917-4645-8ec7-f2bc49e037e82026-07-29WarningsExact identifier
unii: V13007Z41A
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEBenco Dental9419ac39-9b26-4cca-a2d6-167205fede242026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
LIDOCAINELIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dental6506755f-c9f7-4286-9ba7-ac5d5745f5e42026-07-28Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Aspercreme Lidocaine with Rosemary and MintLIDOCAINE HYDROCHLORIDEChattem, Inc.9d40bfea-85d0-4943-83e9-0c16e79a011c2026-07-28WarningsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLC27e8fdfb-e923-4f99-aff7-8b9e502281512026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEDarby Dental Supply, LLCe5ed4c2a-e320-48cf-a2fd-61d48481c6242026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
LidocaineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATEPatterson Dentalf074c0dc-7c3f-46fd-a480-b8337a19fe5c2026-07-27Warnings, Adverse reactionsExact identifier
unii: V13007Z41A
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
unii: 4T6H12BN9U
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
unii: 4T6H12BN9U
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCf8fa72db-5f7a-4158-a2b3-f8bc0e12df9f2026-07-24WarningsExact identifier
unii: V13007Z41A
AEROBURNLIDOCAINE HYDROCHLORIDEAero Healthcare US LLCa32cbc19-ec30-4634-b70d-664f2a2edd952026-07-24WarningsExact identifier
unii: V13007Z41A

Reported adverse events (FAERS/openFDA)#

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