FDA.reportPublic FDA data

lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream

RxCUI
1314136
RxNorm name
lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream
Display name
Lidocaine/Phenylephrine (Rectal)
Full name
lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream
Term type
SCD
Status
Active
Strength
5-0.25%
Dose form
Cream
Route
Rectal
Updated
2026-07-23 06:53:41

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
112012
Active start
112012
Multiple ingredient
YES
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine50 MG / 1 MLlidocainelidocaine
phenylephrine hydrochloride2.5 MG / 1 MLphenylephrinephenylephrine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Rectal Cream316975

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387
phenylephrine8163

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRlidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamNAMES
RxNorm Namelidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamNAMES
RxNorm Synonymlidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamNAMES
TTYSCDATTRIBUTES
SPL_SET_ID10d2c3e4-cf4d-42ce-8fc3-33b97f63cccdCODES
SPL_SET_ID36eccc74-107e-3914-e063-6294a90a1856CODES
SPL_SET_ID3c81ea45-0baf-8c4b-e063-6394a90ad761CODES
SPL_SET_ID41442fa7-c511-07ca-e063-6294a90a3992CODES
SPL_SET_ID580559bf-d91f-4bb3-9c9b-b7e2cd0686fdCODES
SPL_SET_IDa1e15d2a-44b6-4d9c-89c2-0ff12285724eCODES
SPL_SET_IDa8f123de-2a73-5bbc-e053-2a95a90a9ddcCODES
RxCUI1314136CODES
MMSL_CODEBD41730CODES
MMSL_CODECD41730CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
63742-038-0163742-038Liposomal Hemorrhoid Master Lidocaine , Phenylephrine HclClinical Resolution Laboratory, Inc.M015
72654-038-0172654-038Hemorrohoid Master Cream Lidocaine, Phenylephrine HclEbanel Laboratories, Inc.M015
73715-007-0173715-007Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% Lidocaine 5% plus Phenylephrine HCL 0.25% CreamMohnark Pharmaceuticals IncM017
85569-008-0185569-008Treatonic hemorrhoid treatment 5% lidocaine100 KARMA INCM017

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
M01563742-038Liposomal Hemorrhoid Master Lidocaine , Phenylephrine HclOTC MONOGRAPH DRUGClinical Resolution Laboratory, Inc.
M01773715-007Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% Lidocaine 5% plus Phenylephrine HCL 0.25% CreamOTC MONOGRAPH DRUGMohnark Pharmaceuticals Inc

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
60008098661rxnav_ndcsyes
63742003801rxnav_ndcsyes
72654003801rxnav_ndcsyes
73715000701rxnav_ndcsyes
84313000205rxnav_ndcsyes
84313000215rxnav_ndcsyes
84313000230rxnav_ndcsyes
84313010115rxnav_ndcsyes
84313010130rxnav_ndcsyes
85569000801rxnav_ndcsyes

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
a1e15d2a-44b6-4d9c-89c2-0ff12285724elidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD220260302
a1e15d2a-44b6-4d9c-89c2-0ff12285724elidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY220260302
a1e15d2a-44b6-4d9c-89c2-0ff12285724elidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN220260302
41442fa7-c511-07ca-e063-6294a90a3992lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN1Initial Drug Listing - Treatonic hemorrhoid treatment 5% lidocaine20251016
41442fa7-c511-07ca-e063-6294a90a3992lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1Initial Drug Listing - Treatonic hemorrhoid treatment 5% lidocaine20251016
41442fa7-c511-07ca-e063-6294a90a3992lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1Initial Drug Listing - Treatonic hemorrhoid treatment 5% lidocaine20251016
3c81ea45-0baf-8c4b-e063-6394a90ad761lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN1Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine 0.25%20250816
3c81ea45-0baf-8c4b-e063-6394a90ad761lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine 0.25%20250816
3c81ea45-0baf-8c4b-e063-6394a90ad761lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine 0.25%20250816
36eccc74-107e-3914-e063-6294a90a1856lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY120250606
36eccc74-107e-3914-e063-6294a90a1856lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN120250606
36eccc74-107e-3914-e063-6294a90a1856lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD120250606
a8f123de-2a73-5bbc-e053-2a95a90a9ddclidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN1CVS Health Maximum Strength Hemorrhoidal Relief Cream20200625
a8f123de-2a73-5bbc-e053-2a95a90a9ddclidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1CVS Health Maximum Strength Hemorrhoidal Relief Cream20200625
a8f123de-2a73-5bbc-e053-2a95a90a9ddclidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY1CVS Health Maximum Strength Hemorrhoidal Relief Cream20200625
9e1f7343-17c7-45f8-963d-ba1a21d4b0f1lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD120101206
9e1f7343-17c7-45f8-963d-ba1a21d4b0f1lidocaine 5 % / phenylephrine HCl 0.25 % Rectal CreamPSN120101206
9e1f7343-17c7-45f8-963d-ba1a21d4b0f1lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal CreamSY120101206

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
a1e15d2a-44b6-4d9c-89c2-0ff12285724eClinical Resolution Laboratory, Inc.20260302
41442fa7-c511-07ca-e063-6294a90a3992Initial Drug Listing - Treatonic hemorrhoid treatment 5% lidocaine100 KARMA INC20251016
3c81ea45-0baf-8c4b-e063-6394a90ad761Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine 0.25%Mohnark Pharmaceuticals Inc20250816
36eccc74-107e-3914-e063-6294a90a1856Ebanel Laboratories, Inc. | Clinical Resolution Laboratory, Inc.20250606

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCC01CAAdrenergic and dopaminergic agentsATC1-4phenylephrine
ATCN01BBAmidesATC1-4lidocaine
ATCS02DAAnalgesics and anestheticsATC1-4lidocaine
ATCD04ABAnesthetics for topical useATC1-4lidocaine
ATCR02ADAnesthetics, localATC1-4lidocaine
ATCC01BBAntiarrhythmics, class IbATC1-4lidocaine
ATCC05ADLocal anestheticsATC1-4lidocaine
ATCS01HALocal anestheticsATC1-4lidocaine
ATCC05AXOther agents for treatment of hemorrhoids and anal fissures for topical useATC1-4phenylephrine
ATCR01BASympathomimeticsATC1-4phenylephrine
ATCS01FBSympathomimetics excl. antiglaucoma preparationsATC1-4phenylephrine
ATCS01GASympathomimetics used as decongestantsATC1-4phenylephrine
ATCR01ABSympathomimetics, combinations excl. corticosteroidsATC1-4phenylephrine
ATCR01AASympathomimetics, plainATC1-4phenylephrine
FDASPLN0000186105alpha-1 Adrenergic AgonistEPChas_epcphenylephrine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine
MEDRTD010656PhenylephrineCHEMhas_ingredientphenylephrine hydrochloride
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine
MEDRTD013447SulfitesCHEMci_chemclassphenylephrine hydrochloride
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withphenylephrine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine hydrochloride
MEDRTD005401Fissure in AnoDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine
MEDRTD005902Glaucoma, Open-AngleDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine
MEDRTD006484HemorrhoidsDISEASEmay_treatphenylephrine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD006973HypertensionDISEASEci_withphenylephrine
MEDRTD006973HypertensionDISEASEci_withphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine hydrochloride
MEDRTD007022HypotensionDISEASEmay_treatphenylephrine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD015878MydriasisDISEASEinducesphenylephrine
MEDRTD015878MydriasisDISEASEinducesphenylephrine hydrochloride
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine
MEDRTD011538Pruritus AniDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine
MEDRTD012223Rhinitis, VasomotorDISEASEmay_treatphenylephrine hydrochloride
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine
MEDRTD012772Shock, SepticDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine hydrochloride
MEDRTD013617Tachycardia, SupraventricularDISEASEmay_treatphenylephrine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD017180Tachycardia, VentricularDISEASEci_withphenylephrine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine
MEDRTN0000000209Adrenergic alpha-AgonistsMOAhas_moaphenylephrine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine
MEDRTN0000008371Conjunctival Arterial VasoconstrictionPEhas_pephenylephrine hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine
MEDRTN0000008896Decreased Nasal and Sinus SecretionsPEhas_pephenylephrine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH50 MG/ML / 2.5 MG/ML
ATTRIBUTESGENERAL_CARDINALITYMULTI
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSCD
CODESMMSL_CODEBD41730
CODESMMSL_CODECD41730
CODESRxCUI1314136
CODESSPL_SET_ID10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd
CODESSPL_SET_ID36eccc74-107e-3914-e063-6294a90a1856
CODESSPL_SET_ID3c81ea45-0baf-8c4b-e063-6394a90ad761
CODESSPL_SET_ID41442fa7-c511-07ca-e063-6294a90a3992
CODESSPL_SET_ID580559bf-d91f-4bb3-9c9b-b7e2cd0686fd
CODESSPL_SET_IDa1e15d2a-44b6-4d9c-89c2-0ff12285724e
CODESSPL_SET_IDa8f123de-2a73-5bbc-e053-2a95a90a9ddc
NAMESPrescribable Synonymlidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream
NAMESRXNAV_STRlidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream
NAMESRxNorm Namelidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream
NAMESRxNorm Synonymlidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon