FDA.reportPublic FDA data

sulfacetamide sodium 98 MG/ML Topical Lotion [Ovace]

RxCUI
1542380
RxNorm name
sulfacetamide sodium 98 MG/ML Topical Lotion [Ovace]
Display name
OVACE (Topical)
Full name
sulfacetamide sodium 98 MG/ML Topical Lotion [Ovace]
Term type
SBD
Status
Active
Strength
9.8%
Dose form
Lotion
Route
Topical
Updated
2026-10-03 19:28:04

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
082014
Active start
082014
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
sulfacetamide sodium98 MG / 1 MLsulfacetamidesulfacetamide sodium

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Lotion316983

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
sulfacetamide10169

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STROvace 98 MG/ML Topical Lotion1NAMES
RxNorm Namesulfacetamide sodium 98 MG/ML Topical Lotion [Ovace]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID073a44cd-f679-48bd-b90d-cf06f32ff07d1CODES
RxCUI15423801CODES
MMSL_CODEBD296591CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0178-0620-040178-0620Ovace SULFACETAMIDE SODIUMMission Pharmacal Company

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 3 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00178062002rxnav_ndcsyes
00178062004rxnav_ndcsyes
00178062094rxnav_historical

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ovace PlusSULFACETAMIDE SODIUMMission Pharmacal Company073a44cd-f679-48bd-b90d-cf06f32ff07d2025-08-13Warnings, Adverse reactionsExact identifier
ndc (package): 0178-0620-04
ndc (product): 0178-0620
ndc11 (package): 00178062002
ndc11 (package): 00178062004
ndc11 (package): 00178062094
rxcui: 1542380

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
073a44cd-f679-48bd-b90d-cf06f32ff07dOvace Plus 9.8 % Topical Lotion [PSN] · sulfacetamide sodium 98 MG/ML Topical Lotion [Ovace] [SBD] · Ovace 98 MG/ML Topical Lotion [SY] · Ovace Plus 9.8 % Topical Lotion [SY]410Ovace Plus (sodium sulfacetamide 9.8%) Lotion20250813

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
073a44cd-f679-48bd-b90d-cf06f32ff07dOvace Plus (sodium sulfacetamide 9.8%) LotionMission Pharmacal Company20250813

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD10AFAntiinfectives for treatment of acneATC1-4sulfacetamide
ATCS01ABSulfonamidesATC1-4sulfacetamide
FDASPLD013449SulfonamidesCHEMhas_chemical_structuresulfacetamide
FDASPLN0000175503Sulfonamide AntibacterialEPChas_epcsulfacetamide
MEDRTD013409SulfacetamideCHEMhas_ingredientsulfacetamide sodium
MEDRTD013409SulfacetamideCHEMhas_ingredientsulfacetamide
MEDRTD003320Corneal UlcerDISEASEmay_treatsulfacetamide
MEDRTD003320Corneal UlcerDISEASEmay_treatsulfacetamide sodium
MEDRTD012628Dermatitis, SeborrheicDISEASEmay_treatsulfacetamide sodium
MEDRTD012628Dermatitis, SeborrheicDISEASEmay_treatsulfacetamide
MEDRTD004342Drug HypersensitivityDISEASEci_withsulfacetamide
MEDRTD004342Drug HypersensitivityDISEASEci_withsulfacetamide sodium
MEDRTD004427Ear DiseasesDISEASEmay_treatsulfacetamide sodium
MEDRTD004427Ear DiseasesDISEASEmay_treatsulfacetamide
MEDRTD007231Infant, NewbornDISEASEci_withsulfacetamide sodium
MEDRTD007231Infant, NewbornDISEASEci_withsulfacetamide
MEDRTD017192Skin Diseases, BacterialDISEASEmay_treatsulfacetamide
MEDRTD017192Skin Diseases, BacterialDISEASEmay_treatsulfacetamide sodium
MEDRTD014141TrachomaDISEASEmay_treatsulfacetamide
MEDRTD014141TrachomaDISEASEmay_treatsulfacetamide sodium
MEDRTN0000009946Para-Aminobenzoic Acid InhibitorsMOAhas_moasulfacetamide
MEDRTN0000009946Para-Aminobenzoic Acid InhibitorsMOAhas_moasulfacetamide sodium
MEDRTN0000008344Cellular Growth Phase ArrestPEhas_pesulfacetamide
MEDRTN0000008344Cellular Growth Phase ArrestPEhas_pesulfacetamide sodium
MEDRTN0000008347Cellular Synthetic Activity AlterationPEhas_pesulfacetamide
MEDRTN0000008347Cellular Synthetic Activity AlterationPEhas_pesulfacetamide sodium
MEDRTN0000009935Decreased Folic Acid ModificationPEhas_pesulfacetamide
MEDRTN0000009935Decreased Folic Acid ModificationPEhas_pesulfacetamide sodium

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH98 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
NAMESPrescribable SynonymOvace Plus 9.8 % Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMultum MediSource Lexicon