Lidocaine HCl - Hydrocortisone Acetate

Product NDC
59088-817
11-digit product format
590880817
Labeler code
59088
Product ID
59088-817_2b4af474-aece-35c6-e063-6294a90ae7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl and Hydrocortisone Acetate
Dosage form
GEL
Route
RECTAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-07-01
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
5.5; 28 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

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage59088-817-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage59088-817-010efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE5.5 mg/g
HYDROCORTISONE ACETATE28 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
1012221Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
454b8854-44d9-4cdb-a2e4-a782e36bed80Available 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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
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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
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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
59088-817-01Lidocaine HCl - Hydrocortisone Acetatewith Aloe1 in 1 KITGEL13
59088-817-07Lidocaine HCl - Hydrocortisone Acetatewith Aloe100 g in 1 TUBEGEL1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-817-01GM - Gram59088-8176e46fe9d-0f58-477f-a34f-fab002f13a5012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO74LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41ALIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
LIDOCAINEACTIVE MOIETY98PI200987LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
HYDROXYETHYL CELLULOSE (4000 MPA.S FOR 1% AQUEOUS SOLUTION)INACTIVE INGREDIENTZYD53NBL45LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
POLYETHYLENE GLYCOL 200INACTIVE INGREDIENTR95B8J264JLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
PROPANEDIOLINACTIVE INGREDIENT5965N8W85TLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RLIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-817LIDOCAINE HCL - HYDROCORTISONE ACETATE WITH ALOE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]3Current NDC, Legacy NDC, 2 package rows20250131_454b8854-44d9-4cdb-a2e4-a782e36bed80.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 Acetate with AloeLIDOCAINE HCL AND HYDROCORTISONE ACETATEPureTek Corporation454b8854-44d9-4cdb-a2e4-a782e36bed802025-01-09Warnings, Adverse reactionsExact identifier
ndc (product): 59088-817

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012221lidocaine HCl 2.8 % / hydrocortisone acetate 0.55 % Rectal GelPSN454b8854-44d9-4cdb-a2e4-a782e36bed803
1012221hydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal GelSCD454b8854-44d9-4cdb-a2e4-a782e36bed803
1012221hydrocortisone acetate 0.55 % / lidocaine hydrochloride 2.8 % Rectal GelSY454b8854-44d9-4cdb-a2e4-a782e36bed803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-817-01590880817011 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) 1 tube2011-07-012026-12-31NoNoCurrent
59088-817-0759088081707100 g in 1 TUBE (59088-817-07) 100 g2011-07-01NoNoCurrent