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, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRlidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream1NAMES
RxNorm Namelidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream1NAMES
RxNorm Synonymlidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
7 linked values
7CODES
RxCUI13141361CODES
MMSL_CODE
2 linked values
2CODES

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#

RxNav current and historical NDC rows page 1 of 1 · 10 matching rows.

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

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
ndc (package): 85569-008-01
ndc (product): 85569-008
ndc11 (package): 85569000801
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
ndc11 (package): 84313000215
ndc11 (package): 84313000230
ndc11 (package): 84313000205
rxcui: 1314136
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
ndc11 (package): 84313010115
ndc11 (package): 84313010130
rxcui: 1314136
Liposomal Hemorrhoid MasterLIDOCAINE , PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.a1e15d2a-44b6-4d9c-89c2-0ff12285724e2026-03-02WarningsExact identifier
ndc (package): 63742-038-01
ndc (product): 63742-038
ndc11 (package): 63742003801
rxcui: 1314136
Hemorrohoid Master CreamLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.36eccc74-107e-3914-e063-6294a90a18562025-06-06WarningsExact identifier
ndc (package): 72654-038-01
ndc (product): 72654-038
ndc11 (package): 72654003801
rxcui: 1314136

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
a1e15d2a-44b6-4d9c-89c2-0ff12285724elidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]3220260302
41442fa7-c511-07ca-e063-6294a90a3992lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]31Initial Drug Listing - Treatonic hemorrhoid treatment 5% lidocaine20251016
3c81ea45-0baf-8c4b-e063-6394a90ad761lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]31Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine 0.25%20250816
36eccc74-107e-3914-e063-6294a90a1856lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]3120250606
a8f123de-2a73-5bbc-e053-2a95a90a9ddclidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]31CVS Health Maximum Strength Hemorrhoidal Relief Cream20200625
9e1f7343-17c7-45f8-963d-ba1a21d4b0f1lidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream [PSN] · lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream [SCD] · lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal Cream [SY]3120101206

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
41442fa7-c511-07ca-e063-6294a90a3992Update - 85569-008-01100 KARMA INC20260812
10d2c3e4-cf4d-42ce-8fc3-33b97f63cccdtina davies IceCream TM Hemorrhoidal CreamTINA DAVIES PROFESSIONAL LLC20260624
580559bf-d91f-4bb3-9c9b-b7e2cd0686fdtina davies IceJelly TM Hemorrhoidal CreamTINA DAVIES PROFESSIONAL LLC20260611
10d2c3e4-cf4d-42ce-8fc3-33b97f63cccdtina davies IceCream TM Hemorrhoidal CreamTINA DAVIES PROFESSIONAL LLC20260608
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
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable Synonymlidocaine 5 % / phenylephrine HCl 0.25 % Rectal Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon