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 5 of 50 · 982 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MICOXASPERGILLUS NIGER VAR. NIGER - CANDIDA ALBICANS - CENTELLA ASIATICA - MALIC ACID - MERCURIC CHLORIDE - RHIZOPUS STOLONIFER - SODIUM DIETHYL OXALACETATE - SULFUR - TABEBUIA IMPETIGINOSA BARK -Guna spa790b50d3-8e1e-4c36-be74-f30c51ca78952026-06-11WarningsExact identifier
unii: 70FD1KFU70
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 70FD1KFU70
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
unii: 70FD1KFU70
Clopoat CLOPOAT ACNE-CLEARING SPOTCOLLOIDAL SULFURGuangzhou Meixi Biotechnology Co., Ltd.53cd1d6b-d44c-2508-e063-6294a90a96c62026-06-09WarningsExact identifier
unii: 70FD1KFU70
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: ZY81Z83H0X
unii: 059QF0KO0R
PanOxyl Pore Refining Acne MaskSULFURCrown Laboratories, Inc.5373574c-95be-dd88-e063-6394a90ae5192026-06-05WarningsExact identifier
unii: 70FD1KFU70
Invisible Fit Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.537cb611-52f4-13a5-e063-6294a90a9f2a2026-06-05WarningsExact identifier
unii: ZY81Z83H0X
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackaaa87a7b-1ff7-43df-b82b-66dee775d8512026-06-01WarningsExact identifier
unii: 70FD1KFU70
Sodium Sulfacetamide and SulfurSULFACETAMIDE SODIUM, SULFURBryant Ranch Prepackdafae162-9cae-4ba6-b8af-8c9bbc0f00102026-06-01WarningsExact identifier
unii: 70FD1KFU70
dermveda ULTRA FOLLICULITIS TREATMENTSULFUR, CURCUMA LONGACelcius Corp.f43bc300-50bf-421a-81f8-1da7fc829cd02026-05-29WarningsExact identifier
unii: 70FD1KFU70
Naturasil Sulfur Lavender Multi-Purpose Relief 5 oz 2 pkSULFUR, THUJA OCCIDENTALISNature's Innovation, Inc.e033a4ae-245b-4abd-9975-f5358c2736a52026-05-28WarningsExact identifier
unii: 70FD1KFU70
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Systane Pro PFPROPYLENE GLYCOLAlcon Laboratories, Inc.a12baf3d-f22b-4c9f-a4c8-4e0d09f6d6f12026-05-12WarningsExact identifier
unii: 6DC9Q167V3
XIMONTH Nail Fungus Care LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.514a998d-aa2a-46b6-e063-6294a90a6c222026-05-08WarningsExact identifier
unii: ZY81Z83H0X
Acne ReliefBELLADONNA, SILICEA, GRAPHITES, HEPAR SULPHURIS CALCAREUM, KALI BROMATUM, LEDUM PALUSTRE, NATRUM MURIATICUM, SELENIUM, SULPHURNaturalCare487b1373-b78c-4510-964a-6ab0fe781ff42026-05-08WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Lymph Tonic IIIECHINACEA (ANGUSTIFOLIA), BOLDO, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, THYROIDINUM (SUIS), GERMANIUM SESQUIOXIDE, ARNICA MONTANA, CALCAREA IODATA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, UBIDECARENONUM, NAJA TRIPUDIANS, CALCAREA PHOSPHORICA, NATRUM SULPHURICUM, PYROGENIUM, SULPHUR, CARCINOSIN, INFLUENZINUMBioActive Nutritional, Inc.c39a5867-6865-43ac-b36f-51cbfcbc415f2026-05-06WarningsExact identifier
unii: 70FD1KFU70
Nail Repairs PatchesGLYCERINShantou Ximonth Biotechnology Co., Ltd.5120b708-047a-1182-e063-6394a90a74c32026-05-06WarningsExact identifier
unii: ZY81Z83H0X
AOAO Acne Buster Salicylic Acid Drying SerumZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.Guangzhou Senmai Biotechnology Co.,Ltd.512185a5-5c1d-ef9f-e063-6394a90a81af2026-05-06WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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