Lidocaine HCl - Hydrocortisone Acetate

Product NDC
59088-838
11-digit product format
590880838
Labeler code
59088
Product ID
59088-838_2b4c24c0-6fe9-1786-e063-6294a90a934b
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
2011-06-22
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
25; 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE25 mg/g
LIDOCAINE HYDROCHLORIDE30 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, V13007Z41A
Rxcui1012223

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
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eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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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
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4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
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da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59088-838-202025-02-01C16284748780-12cef2736-6e2b-d83d-e063-dadaa90ab31fLidocaine HCl 3%- Hydrocortisone Acetate 2.5%
59088-838-202025-01-30C16284748780-12cef2736-6e2b-d83d-e063-dadaa90ab31fLidocaine HCl 3%- Hydrocortisone Acetate 2.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-838-01Lidocaine HCl - Hydrocortisone Acetate7 g in 1 TUBEGEL73
59088-838-20Lidocaine HCl - Hydrocortisone Acetate20 in 1 KITGEL203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-838-20EA - Each59088-8388b99e723-935a-43c2-8285-2695b227a45c12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-838LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) GEL [PURETEK CORPORATION]3Current NDC, Legacy NDC, 2 package rows20250201_0db13203-e001-42fc-b3a2-7f189d171de3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012223lidocaine HCl 3 % / hydrocortisone acetate 2.5 % Rectal GelPSN0db13203-e001-42fc-b3a2-7f189d171de33
1012223hydrocortisone acetate 0.025 MG/MG / lidocaine hydrochloride 0.03 MG/MG Rectal GelSCD0db13203-e001-42fc-b3a2-7f189d171de33
1012223hydrocortisone acetate 2.5 % / lidocaine HCl 3 % Rectal GelSY0db13203-e001-42fc-b3a2-7f189d171de33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-838-01590880838017 g in 1 TUBE (59088-838-01) 7 g2011-06-22NoNoHistorical
59088-838-205908808382020 TUBE in 1 KIT (59088-838-20) > 7 g in 1 TUBE (59088-838-01) 20 tube2011-06-220000-00-00NoNoCurrent