FDA.reportPublic FDA data

hydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal Gel

RxCUI
1012221
RxNorm name
hydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal Gel
Display name
Hydrocortisone/Lidocaine (Rectal)
Full name
hydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal Gel
Term type
SCD
Status
Active
Strength
0.55-2.8%
Dose form
Gel
Route
Rectal
Updated
2026-06-16 07:06:22

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
hydrocortisone acetate0.0055 MG / 1 MGhydrocortisonehydrocortisone acetate
lidocaine hydrochloride0.028 MG / 1 MGlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Rectal Gel346170

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
hydrocortisone5492
lidocaine6387

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRhydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal GelNAMES
RxNorm Namehydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal GelNAMES
RxNorm Synonymhydrocortisone acetate 0.55 % / lidocaine hydrochloride 2.8 % Rectal GelNAMES
TTYSCDATTRIBUTES
SPL_SET_ID454b8854-44d9-4cdb-a2e4-a782e36bed80CODES
RxCUI1012221CODES
MMSL_CODEBD16279CODES
MMSL_CODECD16279CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
59088-817-0159088-817Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone AcetatePureTek Corporation
59088-817-0759088-817Lidocaine HCl - Hydrocortisone Acetate Lidocaine HCl and Hydrocortisone AcetatePureTek Corporation

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
59088081701rxnav_ndcsyes
59088081707rxnav_ndcsyes
59088050042rxnav_historical
66663035701rxnav_historical_indirect
66663035705rxnav_historical_indirect
66663035720rxnav_historical_indirect
66739001820rxnav_historical_indirect
68032031815rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
454b8854-44d9-4cdb-a2e4-a782e36bed80hydrocortisone acetate 0.55 % / lidocaine hydrochloride 2.8 % Rectal GelSY3Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55%20250109
454b8854-44d9-4cdb-a2e4-a782e36bed80lidocaine HCl 2.8 % / hydrocortisone acetate 0.55 % Rectal GelPSN3Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55%20250109
454b8854-44d9-4cdb-a2e4-a782e36bed80hydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal GelSCD3Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55%20250109

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
454b8854-44d9-4cdb-a2e4-a782e36bed80Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55%PureTek Corporation20250109

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4lidocaine
ATCS02DAAnalgesics and anestheticsATC1-4lidocaine
ATCD04ABAnesthetics for topical useATC1-4lidocaine
ATCR02ADAnesthetics, localATC1-4lidocaine
ATCC01BBAntiarrhythmics, class IbATC1-4lidocaine
ATCS02BACorticosteroidsATC1-4hydrocortisone
ATCC05AACorticosteroidsATC1-4hydrocortisone
ATCA07EACorticosteroids acting locallyATC1-4hydrocortisone
ATCA01ACCorticosteroids for local oral treatmentATC1-4hydrocortisone
ATCS01BACorticosteroids, plainATC1-4hydrocortisone
ATCD07AACorticosteroids, weak (group I)ATC1-4hydrocortisone
ATCD07XACorticosteroids, weak, other combinationsATC1-4hydrocortisone
ATCS01CBCorticosteroids/antiinfectives/mydriatics in combinationATC1-4hydrocortisone
ATCH02ABGlucocorticoidsATC1-4hydrocortisone
ATCS01HALocal anestheticsATC1-4lidocaine
ATCC05ADLocal anestheticsATC1-4lidocaine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175576CorticosteroidEPChas_epchydrocortisone
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone
MEDRTD006854HydrocortisoneCHEMhas_ingredienthydrocortisone acetate
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine hydrochloride
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine hydrochloride
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone
MEDRTD000312Adrenal Hyperplasia, CongenitalDISEASEmay_treathydrocortisone acetate
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone
MEDRTD000309Adrenal InsufficiencyDISEASEmay_treathydrocortisone acetate
MEDRTD002056BurnsDISEASEmay_treatlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone
MEDRTD003093Colitis, UlcerativeDISEASEmay_treathydrocortisone acetate
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone
MEDRTD003877Dermatitis, ContactDISEASEmay_treathydrocortisone acetate
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone
MEDRTD003881DermatomycosesDISEASEci_withhydrocortisone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone
MEDRTD004342Drug HypersensitivityDISEASEci_withhydrocortisone acetate
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone
MEDRTD005148Facial DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone
MEDRTD005533Foot DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD006229Hand DermatosesDISEASEmay_treathydrocortisone
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone acetate
MEDRTD006484HemorrhoidsDISEASEmay_treathydrocortisone
MEDRTD006967HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD007249InflammationDISEASEmay_treathydrocortisone
MEDRTD007249InflammationDISEASEmay_treathydrocortisone acetate
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone
MEDRTD007868Leg DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD009203Myocardial InfarctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone
MEDRTD011538Pruritus AniDISEASEmay_treathydrocortisone acetate
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone acetate
MEDRTD012216Rheumatic DiseasesDISEASEmay_treathydrocortisone
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone acetate
MEDRTD012536Scalp DermatosesDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone
MEDRTD012769ShockDISEASEmay_treathydrocortisone acetate
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone
MEDRTD012876Skin Diseases, ParasiticDISEASEci_withhydrocortisone acetate
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone
MEDRTD017193Skin Diseases, ViralDISEASEci_withhydrocortisone acetate
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone
MEDRTD013224Status AsthmaticusDISEASEmay_treathydrocortisone acetate
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine hydrochloride
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine hydrochloride
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone
MEDRTD014382Tuberculosis, CutaneousDISEASEci_withhydrocortisone acetate
MEDRTD018754Ventricular DysfunctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine hydrochloride
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine hydrochloride
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone acetate
MEDRTN0000000159Glucocorticoid Receptor AgonistsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone
MEDRTN0000000134Lipoxygenase InhibitorsMOAhas_moahydrocortisone acetate
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone
MEDRTN0000008327Carbohydrate Metabolism AlterationPEhas_pehydrocortisone acetate
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine hydrochloride
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone
MEDRTN0000010253Decreased Capillary PermeabilityPEhas_pehydrocortisone acetate
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone
MEDRTN0000010248Decreased Fibroblast MigrationPEhas_pehydrocortisone acetate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone acetate
MEDRTN0000008645Decreased Glucocorticoid SecretionPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone
MEDRTN0000008681Decreased Leukotriene ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone acetate
MEDRTN0000008700Decreased Lysosomal FunctionPEhas_pehydrocortisone
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone
MEDRTN0000010246Decreased Polymorphonuclear Leukocyte MigrationPEhas_pehydrocortisone acetate
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone acetate
MEDRTN0000008834Decreased Prostaglandin ActivityPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone
MEDRTN0000008841Decreased Protein SynthesisPEhas_pehydrocortisone acetate

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.0055 MG/MG (expressed as hydrocortisone acetate) / 0.028 MG/MG
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD16279
CODESMMSL_CODECD16279
CODESRxCUI1012221
CODESSPL_SET_ID454b8854-44d9-4cdb-a2e4-a782e36bed80
NAMESPrescribable Synonymlidocaine HCl 2.8 % / hydrocortisone acetate 0.55 % Rectal Gel
NAMESRXNAV_STRhydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal Gel
NAMESRxNorm Namehydrocortisone acetate 0.0055 MG/MG / lidocaine hydrochloride 0.028 MG/MG Rectal Gel
NAMESRxNorm Synonymhydrocortisone acetate 0.55 % / lidocaine hydrochloride 2.8 % Rectal Gel
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary