FDA.reportPublic FDA data

sulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]

RxCUI
1006693
RxNorm name
sulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]
Display name
KLARON (Topical)
Full name
sulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]
Term type
SBD
Status
Active
Strength
10%
Dose form
Lotion
Route
Topical
Updated
2026-06-13 07:05:12

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
092010
Active start
092010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
sulfacetamide sodium100 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, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRKlaron 10 % Topical LotionNAMES
RxNorm Namesulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]NAMES
RxNorm SynonymKlaron (sulfacetamide sodium 10 % ) Topical LotionNAMES
RxNorm SynonymKlaron 10 % Topical LotionNAMES
RxNorm SynonymKlaron 100 MG/ML Topical LotionNAMES
TTYSBDATTRIBUTES
SPL_SET_ID66ab38ea-5cea-47be-97f2-486517999fb0CODES
RxCUI1006693CODES
MMSL_CODEBD3183CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0187-5198-040187-5198Klaron sulfacetamide sodiumBausch Health US, LLCNDA019931

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0199310187-5198Klaron sulfacetamide sodiumNDABausch Health US, LLC

RxNav Current And Historical NDCs#

NDC11, Source, Active table
NDC11SourceActive
00187519804rxnav_ndcsyes
00066750002rxnav_historical
00066750004rxnav_historical
00066750011rxnav_historical
00801750002rxnav_historical
00801750004rxnav_historical
00801750011rxnav_historical
49396031909rxnav_historical_indirect
49396031943rxnav_historical_indirect
54868540100rxnav_historical
64734075004rxnav_historical
64734075011rxnav_historical

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
66ab38ea-5cea-47be-97f2-486517999fb0Klaron (sulfacetamide sodium 10 % ) Topical LotionSY7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0sulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]SBD7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0Klaron 10 % Topical LotionSY7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0Klaron 10 % Topical LotionPSN7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0Klaron 100 MG/ML Topical LotionSY7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
5a005021-dfa1-4aeb-8661-045516723bafKlaron 10 % Topical LotionPSN1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafKlaron 100 MG/ML Topical LotionSY1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafKlaron 10 % Topical LotionSY1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafsulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]SBD1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafKlaron (sulfacetamide sodium 10 % ) Topical LotionSY1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
66ab38ea-5cea-47be-97f2-486517999fb0Klaron ® sodium sulfacetamide lotion Lotion, 10%Bausch Health US, LLC | Bausch Health Companies Inc20200831
5a005021-dfa1-4aeb-8661-045516723bafKLARON® (sodium sulfacetamide lotion) Lotion, 10%Physicians Total Care, Inc.20120502

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_STRENGTH100 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD3183
CODESNDANDA019931
CODESRxCUI1006693
CODESSPL_SET_ID66ab38ea-5cea-47be-97f2-486517999fb0
NAMESPrescribable SynonymKlaron 10 % Topical Lotion
NAMESRXNAV_STRKlaron 10 % Topical Lotion
NAMESRxNorm Namesulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]
NAMESRxNorm SynonymKlaron (sulfacetamide sodium 10 % ) Topical Lotion
NAMESRxNorm SynonymKlaron 10 % Topical Lotion
NAMESRxNorm SynonymKlaron 100 MG/ML Topical Lotion
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon