FDA.reportPublic FDA data

NDC 52389-173-01 - Prosacea

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
52389-173
Requested NDC
52389-173-01
Package NDCs from labels
52389-173-01, 52389-173-21, 52389-173-42
Manufacturer
Kobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC
Effective date
2026-10-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prosacea GelKobayashi Healthcare International, Inc. | Kobayashi America Manufacturing, LLC2026-10-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52389-173-01Prosacea21 g in 1 TUBEGEL2111
52389-173-21Prosacea1 in 1 CARTONGEL111
52389-173-42Prosacea2 in 1 CARTONGEL211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52389-173PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]10Current NDC, Legacy NDC, 3 package rows20240509_e5907672-3ee1-44d3-9c92-6345ad3f4238.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SulfurACTIVE INGREDIENT70FD1KFU70PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
SulfurACTIVE MOIETY70FD1KFU70PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
CARBOMER 934INACTIVE INGREDIENTZ135WT9208PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW4PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
LactoseINACTIVE INGREDIENTJ2B2A4N98GPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPROSACEA (SULPHUR) GEL [ALVA-AMCO PHARMACAL COMPANIES, INC.]3

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 7 of 50 · 982 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and MucusANTIMONIUM TARTARICUM, EUPHRASIA OFFICINALIS, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PULSATILLA (PRATENSIS), STANNUM METALLICUM, SULPHURNaturalCare5435e0ba-eef9-42a9-8301-aacacd2409b12026-03-23WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9.8% Sulfur 4.8% CleanserSODIUM SULFACETAMIDE 9.8% SULFUR 4.8%Oncor Pharmaceuticals400646ae-94d1-4825-a737-161c4128e9d82026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% Sulfur 4% CLEANSERSODIUM SULFACETAMIDE AND SULFUROncor Pharmaceuticalsd44a7a26-ea6b-469f-931a-812a031868ea2026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 5% CleanserSODIUM SULFACETAMIDE 10% AND SULFUR 5%Oncor Pharmaceuticalsf5fecb2b-52d7-4373-b432-ad23aa93085e2026-03-22Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMBryant Ranch Prepack4ebfcaae-a375-45aa-a7f9-2b622f564f022026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5dbcde27-8c20-4ecc-81f7-117e0b0cadf32026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack25516616-2249-4b4f-be31-1a4378d038612026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackfb0c9508-0ff1-46eb-8df0-4bfd2c1231872026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack5ddd93cf-cfeb-460c-b2c5-83f501ef9ab92026-03-19Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
dermveda ULTRA EYE REMEDYSULPHUR, CURCUMA LONGACelcius Corp.1088f138-dacb-4a7b-a623-c49e41bccb672026-03-18WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lymph Tonic IIIADENOSINUM TRIPHOSPHORICUM DINATRUM, ARNICA MONTANA, BOLDO, CALCAREA IODATA, CALCAREA PHOSPHORICA, CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), GERMANIUM SESQUIOXIDE, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, INFLUENZINUM (2024-2025), NAJA TRIPUDIANS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, PYROGENIUM, SULPHUR, THYROIDINUM (SUIS), UBIDECARENONUMBioActive Nutritional, Inc.14f87aa6-2005-4939-a612-1162bbc5462b2026-03-18WarningsExact identifier
unii: 70FD1KFU70
Naturasil Mite B Gone 5 oz 2 packSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.f12c4a7b-75ed-46e6-a0dd-b119538729c72026-03-17WarningsExact identifier
unii: 70FD1KFU70
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
DrainageECHINACEA (ANGUSTIFOLIA), TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, CALCAREA IODATA, KALI MURIATICUM, NITRICUM ACIDUM, PHOSPHORICUM ACIDUM, SULPHURBioActive Nutritional, Inc.7e573986-60c2-40df-9e28-e7f1d9fe1a992026-03-13WarningsExact identifier
unii: 70FD1KFU70
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
unii: 6DC9Q167V3
Tattoo numbing creamHEMP SEED OILGuangzhou Mizi Biotechnology Co., LTD.4cd03bed-99be-e4e8-e063-6294a90a94542026-03-12WarningsExact identifier
unii: ZY81Z83H0X
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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