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 9 of 50 · 982 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
unii: ZY81Z83H0X
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticals, LLCd35a7764-f3c6-fd1b-e053-2a95a90a80362026-02-12WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770b9e2-dbbe-c246-e053-2995a90a398d2026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 9% and Sulfur 4.5% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd770860b-ecbd-ba22-e053-2a95a90af6912026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 8% and Sulfur 4% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd8dcbf63-58f0-0a25-e053-2a95a90a76332026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide 10% and Sulfur 2% CleanserSULFACETAMIDE SODIUM, SULFURMethod Pharmaceuticalsd736fbd6-4cff-bc33-e053-2a95a90a26fd2026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE 10% AND SULFUR 5% Emollient CreamSODIUM SULFACETAMIDE 10% AND SULFUR 5% EMOLLIENT CREAMMethod Pharmaceuticals, LLCdfc5bab2-2170-606e-e053-2a95a90a39612026-02-12Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
sulfacetamide sodium and sulfur Sodium Sulfacetamide - SulfurSULFACETAMIDE SODIUM AND SULFURAllegis Pharmaceuticals, LLC1aa1025f-c568-34d3-e063-6394a90a37b82026-02-11Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
dermveda NAIL FUNGUS SERUMOLIVE EXTRACT, SULFURCelcius Corp.6d999dac-7b84-4f19-957e-5c787a4e96c42026-02-09WarningsExact identifier
unii: 70FD1KFU70
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Dermveda JOCK ITCHSULPHUR, CURCUMA LONGACelcius Corp.bb9c3941-a778-49ba-b58c-75ab5b93b3d02026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda PSORIASIS AND SEBORRHEIC DERMATITISSULFUR, CURCUMA LONGACelcius Corp.a05c1e45-ca2f-49a1-a3f9-32dc51278fb62026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda SCABIES ITCH RELIEF SERUMOLIVE EXTRACT, SULFURCelcius Corp.86a8bffd-81a8-4f22-89b6-e51158f336db2026-02-09WarningsExact identifier
unii: 70FD1KFU70
dermveda JOCK ITCHOLIVE EXTRACT, SULFURCelcius Corp.252ed439-0e4c-419f-8b34-d1b52da8464f2026-02-06WarningsExact identifier
unii: 70FD1KFU70
Cough and Mucus NightANTIMONIUM TARTARICUM, AVENA SATIVA, BRYONIA (ALBA), CHAMOMILLA, DROSERA (ROTUNDIFOLIA), HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, PASSIFLORA INCARNATA, PULSATILLA (PRATENSIS), SAMBUCUS NIGRA, STANNUM METALLICUM, SULPHURNaturalCaref27e3a7f-78a3-4003-95fc-0b32671df4432026-02-02WarningsExact identifier
unii: 70FD1KFU70
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
unii: 70FD1KFU70
SODIUM SULFACETAMIDE, SULFURSODIUM SULFACETAMIDE 9.8% SULFUR 4.8%Aspen Medical LLC4915e4eb-5307-d2db-e063-6394a90a67b32026-01-23Warnings, Adverse reactionsExact identifier
unii: 70FD1KFU70
Joint Tonic R IGINKGO BILOBA, DIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, VISCUM ALBUM, PINUS SYLVESTRIS, APIS MELLIFICA, DULCAMARA, KALMIA LATIFOLIA, LYCOPODIUM CLAVATUM, SULPHURBioActive Nutritional, Inc.183e5794-76a4-450f-9686-7828e46855a32026-01-21WarningsExact identifier
unii: 70FD1KFU70
Naturasil Mite B Gone EXTREME BATH SOAKSULFURNature's Innovation, Inc.e94a0255-3ec1-4d68-93cf-80d4d7c99f7a2026-01-20WarningsExact identifier
unii: 70FD1KFU70
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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