Lidocaine HCl - Hydrocortisone Acetate

Product NDC
59088-816
11-digit product format
590880816
Labeler code
59088
Product ID
59088-816_2b4af474-aeb8-35c6-e063-6294a90ae7dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lidocaine HCl and Hydrocortisone Acetate
Dosage form
CREAM
Route
RECTAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-07-01
Substance
HYDROCORTISONE ACETATE; LIDOCAINE HYDROCHLORIDE
Active strength
20; 20 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 ACETATE20 mg/g
LIDOCAINE HYDROCHLORIDE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3X7931PO74, V13007Z41A
Rxcui1012233

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
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332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
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a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-816-01Lidocaine HCl - Hydrocortisone Acetate7 g in 1 TUBECREAM73
59088-816-24Lidocaine HCl - Hydrocortisone Acetate24 in 1 KITCREAM243

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-816-24EA - Each59088-816313da0bb-54a1-4967-b314-6eb0e7ec280412012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-816LIDOCAINE HCL - HYDROCORTISONE ACETATE (LIDOCAINE HCL AND HYDROCORTISONE ACETATE) CREAM [PURETEK CORPORATION]3Current NDC, Legacy NDC, 2 package rows20250131_ac6c6117-97cc-4b7a-a831-03fb23a54b70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1012233hydrocortisone acetate 2 % / lidocaine HCl 2 % Rectal CreamPSNac6c6117-97cc-4b7a-a831-03fb23a54b703
1012233hydrocortisone acetate 20 MG/ML / lidocaine hydrochloride 20 MG/ML Rectal CreamSCDac6c6117-97cc-4b7a-a831-03fb23a54b703
1012233hydrocortisone acetate 2 % / lidocaine hydrochloride 2 % Rectal CreamSYac6c6117-97cc-4b7a-a831-03fb23a54b703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-816-01590880816017 g in 1 TUBE (59088-816-01) 7 g2011-07-01NoNoHistorical
59088-816-245908808162424 TUBE in 1 KIT (59088-816-24) > 7 g in 1 TUBE (59088-816-01) 24 tube2011-07-010000-00-00NoNoCurrent