FDA.reportPublic FDA data

Lidocaine HCl - Hydrocortisone Acetate

Product NDC
59088-819
11-digit product format
590880819
Labeler code
59088
Product ID
59088-819_2ce29434-b0f8-330a-e063-6394a90a75e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl and Hydrocortisone Acetate
Dosage form
CREAM
Route
RECTAL; TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-07-01
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
5; 30 mg/g; mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59088-81959088-819-03DDiscontinued by firm2026-08-03
excluded packagepackage59088-81959088-819-07DDiscontinued by firm2026-08-03
excluded packagepackage59088-81959088-819-14DDiscontinued by firm2026-08-03
excluded packagepackage59088-81959088-819-20DDiscontinued by firm2026-08-03

Additional Listing Data#

Finished product
Yes
Brand name base
Lidocaine HCl - Hydrocortisone Acetate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5 mg/g
HYDROCORTISONE ACETATE30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V13007Z41AInternal UNII lookup
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1012235Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3a24be46-df26-477e-b909-04dd14d0a014Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-819-01Lidocaine HCl - Hydrocortisone Acetate7 g in 1 TUBECREAM77
59088-819-03Lidocaine HCl - Hydrocortisone Acetate1 in 1 CARTONCREAM17
59088-819-03Lidocaine HCl - Hydrocortisone Acetate28.3 g in 1 TUBECREAM28.37
59088-819-07Lidocaine HCl - Hydrocortisone Acetate85 g in 1 TUBECREAM857
59088-819-07Lidocaine HCl - Hydrocortisone Acetate1 in 1 CARTONCREAM17
59088-819-14Lidocaine HCl - Hydrocortisone Acetate14 in 1 KITCREAM147
59088-819-20Lidocaine HCl - Hydrocortisone Acetate20 in 1 KITCREAM207
59088-819-01Lidocaine HCl 3% and Hydrocortisone Acetate 0.5% Cream7 g in 1 TUBECREAM20 g in 75 mg in 1g3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-819-01GM - Gram59088-819417bf683-a3c7-4770-a899-607119b1b9a112024-04-05
59088-819-03GM - Gram59088-819cd5bb80a-145a-4a13-b3ba-5f82f4cd793e12012-07-24
59088-819-07GM - Gram59088-81975747fb6-4105-4d06-9f82-c9b686b0cea012012-07-24
59088-819-14GM - Gram59088-8192186a7c4-d3f8-4985-870f-b7240468ef0c12012-07-24
59088-819-20EA - Each59088-8195f1402b7-f98e-4194-9e1c-1a99a91a9e9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
ALUMINUM SULFATEINACTIVE INGREDIENT34S289N54ELIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-819LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]7Current NDC, Legacy NDC, 7 package rows20250207_3a24be46-df26-477e-b909-04dd14d0a014.zip

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lidocaine HCl - Hydrocortisone AcetateLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation3a24be46-df26-477e-b909-04dd14d0a0142025-01-29Warnings, Adverse reactionsExact identifier
ndc (product): 59088-819

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012235hydrocortisone acetate 0.5 % / lidocaine HCl 3 % Rectal CreamPSN3a24be46-df26-477e-b909-04dd14d0a0147
1012235hydrocortisone acetate 5 MG/ML / lidocaine hydrochloride 30 MG/ML Rectal CreamSCD3a24be46-df26-477e-b909-04dd14d0a0147
1012235hydrocortisone acetate 0.5 % / lidocaine hydrochloride 3 % Rectal CreamSY3a24be46-df26-477e-b909-04dd14d0a0147
1012235hydrocortisone acetate 0.5 % / lidocaine HCl 3 % Rectal CreamPSN3881327f-c3fc-7df2-e063-6294a90a468d3
1012235hydrocortisone acetate 5 MG/ML / lidocaine hydrochloride 30 MG/ML Rectal CreamSCD3881327f-c3fc-7df2-e063-6294a90a468d3
1012235hydrocortisone acetate 0.5 % / lidocaine hydrochloride 3 % Rectal CreamSY3881327f-c3fc-7df2-e063-6294a90a468d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-819-01590880819017 g in 1 TUBE (59088-819-01) 7 g2011-07-01NoNoCurrent
59088-819-03590880819031 TUBE in 1 CARTON (59088-819-03) > 28.3 g in 1 TUBE1 tube2011-07-010000-00-00NoNoCurrent
59088-819-07590880819071 TUBE in 1 CARTON (59088-819-07) > 85 g in 1 TUBE1 tube2011-07-010000-00-00NoNoCurrent
59088-819-145908808191414 TUBE in 1 KIT (59088-819-14) > 7 g in 1 TUBE (59088-819-01) 14 tube2011-07-010000-00-00NoNoCurrent
59088-819-205908808192020 TUBE in 1 KIT (59088-819-20) > 7 g in 1 TUBE (59088-819-01) 20 tube2011-07-010000-00-00NoNoCurrent