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 1 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProsaceaSULPHURKobayashi Healthcare International, Inc.e5907672-3ee1-44d3-9c92-6345ad3f42382026-10-30WarningsExact identifier
ndc (package): 52389-173-21
ndc (package): 52389-173-01
ndc (package): 52389-173-42
ndc (product): 52389-173
ndc11 (package): 52389017301
spl id: 55179acd-293a-7e75-e063-6294a90a23fa
spl set id: e5907672-3ee1-44d3-9c92-6345ad3f4238
unii: 70FD1KFU70
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: 70FD1KFU70
VertiFixARGENTUM NITRICUM, BRYONIA (ALBA), CAUSTICUM, COCCULUS INDICUS, GELSEMIUM SEMPERVIRENS, IPECACUANHA, NUX VOMICA, PETROLEUM, SULPHUR, TABACUMNaturalCare33b00f06-3202-4904-855c-cdfaa93677a42026-08-27WarningsExact identifier
unii: 70FD1KFU70
Allergy CareADRENALINUM, RAGWEED, POLLEN (AMBROSIA ARTEMISIAEFOLIA), APIS MELLIFICA, ECHINACEA (ANGUSTIFOLIA), HISTAMINUM HYDROCHLORICUM, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHURNaturalCaref3ca7f5a-1448-4670-ac02-b47ffb6c55852026-08-27WarningsExact identifier
unii: 70FD1KFU70
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hylands Naturals Earache DropsBELLADONNA LEAF,CALCIUM CARBONATE,CHAMOMILE,LYCOPODIUM CLAVATUM SPORE,ANEMONE PATENS WHOLE,SULFURHyland's Inc.017ed754-9fe8-2cb5-e063-6294a90ab2f62026-08-24WarningsExact identifier
unii: 70FD1KFU70
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: 70FD1KFU70
Naturasil Tinea Versicolor ReliefSULFURNature's Innovation, Inc.255f4fdb-bcc5-45e2-b9bd-06908bfbe23b2026-08-19WarningsExact identifier
unii: 70FD1KFU70
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
MENTOL CHINO FORTEMETHYL SALICYLATE, MENTHOL, CAMPHORLABORATORIOS H.G. C.A.12652c98-e2a8-21fc-e063-6394a90a94cb2026-08-17WarningsExact identifier
unii: 70FD1KFU70
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM104 DROPSCALC FLUOR, CHIMAPHILA, FERR PHOS, HYDRANGEA, KALI PHOS, SAW PALMETTO, SULPHURBM Private Limited5900caa3-e5b2-54d7-e063-6294a90adac22026-08-14WarningsExact identifier
unii: 70FD1KFU70
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: 70FD1KFU70
Neraxiva Men S Intimate Care (Moisture Care Cream)SULPHURGuangdong Xinhongda Trading Service Co., Ltd.58e8c35d-219b-02fd-e063-6294a90a9f902026-08-13WarningsExact identifier
unii: 70FD1KFU70
BM BM53 DROPSAPIS MELLIFICA, APIUM VIRUS, ARSENIC ALB., BRYONIA ALBA, SULPHURBM Private Limited58eeb0eb-d09a-b979-e063-6394a90ad84d2026-08-13WarningsExact identifier
unii: 70FD1KFU70
BM BM59 DROPSCALC CARB, DULCAMARA, HEPAR SULPH, LYCOPODIUM, NAT MUR, SULPHUR, THUJA OCCBM Private Limited58ef0755-c2cd-b7c2-e063-6294a90a27072026-08-13WarningsExact identifier
unii: 70FD1KFU70
Spot CorrectionSULFURHydroPeptide LLC45ec40ff-7134-085b-e054-00144ff8d46c2026-08-12WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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