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

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
HYDROCORTISONE ACETATE5.5 mg/g
LIDOCAINE HYDROCHLORIDE28 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, V13007Z41A
Rxcui1012221

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
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9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
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bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
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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

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 g2011-07-01NoNoHistorical