FDA.reportPublic FDA data

sulfacetamide sodium 100 MG/ML Topical Lotion

RxCUI
1006688
RxNorm name
sulfacetamide sodium 100 MG/ML Topical Lotion
Display name
Sulfacetamide (Topical)
Full name
sulfacetamide sodium 100 MG/ML Topical Lotion
Term type
SCD
Status
Active
Strength
10%
Dose form
Lotion
Route
Topical
Updated
2026-06-13 07:05:06

RxNorm Status History#

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

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_STRsulfacetamide sodium 100 MG/ML Topical LotionNAMES
RxNorm Namesulfacetamide sodium 100 MG/ML Topical LotionNAMES
RxNorm Synonymsulfacetamide sodium 10 % Topical LotionNAMES
RxNorm Synonymsulfacetamide sodium 10 % Topical SuspensionNAMES
TTYSCDATTRIBUTES
SPL_SET_ID4fb4d39a-330e-4c84-abbc-3b33b36b206fCODES
SPL_SET_ID6fa7399b-4ced-492d-b6f6-cf155764087aCODES
RxCUI1006688CODES
MMSL_CODEBD3183CODES
MMSL_CODECD3183CODES
MMSL_CODECD9208CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
45802-896-2645802-896Sulfacetamide Sodium Sulfacetamide SodiumPadagis Israel Pharmaceuticals LtdANDA078649
68682-010-0468682-010Sodium sulfacetamide Sodium sulfacetamideOceanside PharmaceuticalsNDA019931

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA07864945802-896Sulfacetamide Sodium Sulfacetamide SodiumANDAPadagis Israel Pharmaceuticals Ltd
NDA01993168682-010Sodium sulfacetamide Sodium sulfacetamideNDA AUTHORIZED GENERICOceanside Pharmaceuticals

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 30 matching rows.

NDC11, Source, Active table
NDC11SourceActive
45802089626rxnav_ndcsyes
68682001004rxnav_ndcsyes
00066750002rxnav_historical_indirect
00066750004rxnav_historical_indirect
00066750011rxnav_historical_indirect
00085060005rxnav_historical_indirect
00168038202rxnav_historical_indirect
00168038204rxnav_historical
00801750002rxnav_historical_indirect
00801750004rxnav_historical_indirect
00801750011rxnav_historical_indirect
10337065319rxnav_historical_indirect
10337065399rxnav_historical_indirect
11527009379rxnav_historical_indirect
11527009473rxnav_historical
49396031909rxnav_historical_indirect
49396031943rxnav_historical_indirect
51672134608rxnav_historical
54868540100rxnav_historical_indirect
54868622500rxnav_historical
61360134608rxnav_historical
63717003599rxnav_historical_indirect
64734075004rxnav_historical_indirect
64734075011rxnav_historical_indirect
65179065319rxnav_historical_indirect
65179065399rxnav_historical_indirect
65255011565rxnav_historical_indirect
65255011590rxnav_historical_indirect
66993087555rxnav_historical
68032010903rxnav_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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sulfacetamide SodiumSULFACETAMIDE SODIUMPadagis Israel Pharmaceuticals Ltd4fb4d39a-330e-4c84-abbc-3b33b36b206f2023-04-01Warnings, Adverse reactionsExact identifier
ndc (package): 45802-896-26
ndc (product): 45802-896
ndc11 (package): 45802089626
rxcui: 1006688
KlaronSULFACETAMIDE SODIUMBausch Health US, LLC66ab38ea-5cea-47be-97f2-486517999fb02020-08-31Warnings, Adverse reactionsExact identifier
rxcui: 1006688
Sodium sulfacetamideSODIUM SULFACETAMIDEOceanside Pharmaceuticals6fa7399b-4ced-492d-b6f6-cf155764087a2019-05-31Warnings, Adverse reactionsExact identifier
ndc (package): 68682-010-04
ndc (product): 68682-010
ndc11 (package): 68682001004
rxcui: 1006688

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
4fb4d39a-330e-4c84-abbc-3b33b36b206fsulfacetamide sodium 10 % Topical SuspensionSY12Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)20230401
4fb4d39a-330e-4c84-abbc-3b33b36b206fsulfacetamide sodium 10 % Topical LotionSY12Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)20230401
4fb4d39a-330e-4c84-abbc-3b33b36b206fsulfacetamide sodium 100 MG/ML Topical LotionSCD12Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)20230401
4fb4d39a-330e-4c84-abbc-3b33b36b206fsulfacetamide sodium 10 % Topical LotionPSN12Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)20230401
66ab38ea-5cea-47be-97f2-486517999fb0sulfacetamide sodium 10 % Topical LotionPSN7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0sulfacetamide sodium 10 % Topical LotionSY7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0sulfacetamide sodium 10 % Topical SuspensionSY7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
66ab38ea-5cea-47be-97f2-486517999fb0sulfacetamide sodium 100 MG/ML Topical LotionSCD7Klaron ® sodium sulfacetamide lotion Lotion, 10%20200831
6fa7399b-4ced-492d-b6f6-cf155764087asulfacetamide sodium 10 % Topical LotionSY5Sodium Sulfacetamide Lotion, 10%20190531
6fa7399b-4ced-492d-b6f6-cf155764087asulfacetamide sodium 100 MG/ML Topical LotionSCD5Sodium Sulfacetamide Lotion, 10%20190531
6fa7399b-4ced-492d-b6f6-cf155764087asulfacetamide sodium 10 % Topical SuspensionSY5Sodium Sulfacetamide Lotion, 10%20190531
6fa7399b-4ced-492d-b6f6-cf155764087asulfacetamide sodium 10 % Topical LotionPSN5Sodium Sulfacetamide Lotion, 10%20190531
5a005021-dfa1-4aeb-8661-045516723bafsulfacetamide sodium 10 % Topical SuspensionSY1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafsulfacetamide sodium 10 % Topical LotionPSN1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafsulfacetamide sodium 100 MG/ML Topical LotionSCD1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
5a005021-dfa1-4aeb-8661-045516723bafsulfacetamide sodium 10 % Topical LotionSY1KLARON® (sodium sulfacetamide lotion) Lotion, 10%20120502
b8e00e27-d3d3-4313-966e-0b50dfeca308sulfacetamide sodium 100 MG/ML Topical LotionSCD1SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%20090901
b8e00e27-d3d3-4313-966e-0b50dfeca308sulfacetamide sodium 10 % Topical LotionPSN1SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%20090901
b8e00e27-d3d3-4313-966e-0b50dfeca308sulfacetamide sodium 10 % Topical LotionSY1SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%20090901
b8e00e27-d3d3-4313-966e-0b50dfeca308sulfacetamide sodium 10 % Topical SuspensionSY1SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%20090901

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4fb4d39a-330e-4c84-abbc-3b33b36b206fSulfacetamide Sodium Topical Suspension USP, 10% (Lotion)Padagis Israel Pharmaceuticals Ltd20230401
4fb4d39a-330e-4c84-abbc-3b33b36b206fSulfacetamide Sodium Topical Suspension USP, 10% (Lotion)Padagis Israel Pharmaceuticals Ltd20230401
6fa7399b-4ced-492d-b6f6-cf155764087aSodium Sulfacetamide Lotion, 10%Oceanside Pharmaceuticals | Bausch Health Companies Inc.20190531
7b69b28d-44ae-4317-b149-76f2126d295aNational Council for Prescription Drug Programs20130303
190cb7df-2647-48aa-91bb-0a5e4d7c8ce2National Council for Prescription Drug Programs20130213
d8ea719a-62c7-4f74-bcf6-5584e4a8260dNational Council for Prescription Drug Programs20130213
7d9135ec-ed8d-460b-8935-bf16dcf4a712Sulfacetamide Sodium Topical Suspension USP, 10% (Lotion)Taro Pharmaceuticals U.S.A., Inc. | Taro Pharmaceuticals Inc.20121012
7cf09cb2-7b9c-404e-9a73-0a5bae2a7bf8National Council for Prescription Drug Programs20120724
92526c19-7605-4862-92bc-c6c1b10f89e8National Council for Prescription Drug Programs20120724
b746fde4-0caa-4237-97d0-fe3289de679fNational Council for Prescription Drug Programs20120724
dbd4fbcd-4d6c-445d-8288-7b368fe5af77National Council for Prescription Drug Programs20120724
5a005021-dfa1-4aeb-8661-045516723bafKLARON® (sodium sulfacetamide lotion) Lotion, 10%Physicians Total Care, Inc.20120502
b8e00e27-d3d3-4313-966e-0b50dfeca308SULFACETAMIDE SODIUM TOPICAL SUSPENSION USP, 10%Physicians Total Care, Inc.20090901

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
ATTRIBUTESTTYSCD
CODESANDAANDA078649
CODESMMSL_CODEBD3183
CODESMMSL_CODECD3183
CODESMMSL_CODECD9208
CODESRxCUI1006688
CODESSNOMEDCT375524008
CODESSPL_SET_ID4fb4d39a-330e-4c84-abbc-3b33b36b206f
CODESSPL_SET_ID6fa7399b-4ced-492d-b6f6-cf155764087a
CODESVUID4004084
CODESVUID4031415
NAMESPrescribable Synonymsulfacetamide sodium 10 % Topical Lotion
NAMESRXNAV_STRsulfacetamide sodium 100 MG/ML Topical Lotion
NAMESRxNorm Namesulfacetamide sodium 100 MG/ML Topical Lotion
NAMESRxNorm Synonymsulfacetamide sodium 10 % Topical Lotion
NAMESRxNorm Synonymsulfacetamide sodium 10 % Topical Suspension
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File