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 4 of 50 · 982 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Magnilife DB Pain Relieving FootAPIS MELLIFERA, LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE, SULFURThe Magni Group, Inc.2c54728e-80b0-4466-9b50-4a69878c90272026-07-01WarningsExact identifier
unii: 70FD1KFU70
Magnilife Pain Relieving FootAPIS MELLIFERA, LEONTOPODIUM NIVALE SUBSP. ALPINUM WHOLE, SULFURThe Magni Group, Inc.626e52cc-3031-47a4-8e31-f5ae51b518462026-07-01WarningsExact identifier
unii: 70FD1KFU70
Medi Fect Antiseptic Hand WashETHYL ALCOHOLMedical Chemical Corporationdc397d9c-9c12-41e5-ab7f-196fcad5bf972026-07-01WarningsExact identifier
unii: H5RIZ3MPW4
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: 70FD1KFU70
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
dermveda ULTRA SKIN ANTI-BACTERIALSULPHUR, CURCUMA LONGACelcius Corp.d4bc6cd6-efa7-4966-83b9-060ddd5cf7ce2026-06-18WarningsExact identifier
unii: 70FD1KFU70
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackfb17c3be-a752-4591-a9f4-ecf32096d65c2026-06-16WarningsExact identifier
unii: 70FD1KFU70
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURTotal Operations Management LLC DBA:Bestmade Natural Products Micro5460d96f-e2b1-51ff-e063-6294a90ac7822026-06-16WarningsExact identifier
unii: 70FD1KFU70
Matrix SupportANACARDIUM ORIENTALE, ARGENTUM NITRICUM, BILE DUCT (SUIS), CEANOTHUS AMERICANUS, COLON (SUIS), CONDURANGO, DUODENUM (SUIS), DYSENTERY BACILLUS, ESOPHAGUS (SUIS), EYE (SUIS), GALLBLADDER (SUIS), HYDRASTIS CANADENSIS, ILEUM (SUIS), INTESTINE (SUIS), IPECACUANHA, JEJUNUM (SUIS), KALI BICHROMICUM, KREOSOTUM, LACHESIS MUTUS, LUNG (SUIS), MANNOSE, MOMORDICA BALSAMINA, MUCOSA NASALIS SUIS, NATRUM OXALACETICUM, ORAL MUCOSA (SUIS), OXALIS ACETOSELLA, PANCREAS SUIS, PHOSPHORUS, PULSATILLA (PRATENSIS),Deseret Biologicals, Inc.9b44f9d1-1ec6-4b01-8992-508a5fb15aae2026-06-15WarningsExact identifier
unii: 70FD1KFU70
BM HAIR SUPPORT DROPSACID PHOS, ARNICA MONT, ARS. ALB., GRAPHITE, JABORANDI, LYCOPODIUM, PHOSPHORUS, SULPHURBM Private Limited544b1ad5-71ab-18e4-e063-6394a90a86352026-06-15WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepack2a8c6cc3-62b6-4682-9670-df9c0e6cb2e12026-06-12WarningsExact identifier
unii: 70FD1KFU70
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
unii: 70FD1KFU70
V HPANAS BARBARIAE, HEPATIS ET CORDIS EXTRACTUM, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CARCINOSIN, ECHINACEA (ANGUSTIFOLIA), EUPATORIUM PERFOLIATUM, GELSEMIUM SEMPERVIRENS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYROGENIUM, RHUS TOX, SULPHUREnergique, Inc.ea12ca3b-19e0-4d4a-9514-4d28d214e1e72026-06-12WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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