FDA.reportPublic FDA data

NDC 57883-404-01 - Plexion

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
57883-404
Requested NDC
57883-404-01
Package NDCs from labels
57883-404-01, 57883-404-60, 57883-404-10
Manufacturer
Brava Pharmaceuticals, LLC
Effective date
2025-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Plexion - Brava Pharmaceuticals, LLCBrava Pharmaceuticals, LLC2025-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57883-404-01Plexion4 g in 1 PACKETCLOTH45
57883-404-10Plexion10 in 1 CARTONCLOTH105
57883-404-60Plexion60 in 1 CARTONCLOTH605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57883-404PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20241213_8211c8ec-b501-4ac6-8185-b4b9758cdc1a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57883-404-60EA - Each57883-404190d85af-3db6-458b-95e5-0d0fde17053812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1

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 47 of 51 · 1,007 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
BHI HemorrhoidHORSE CHESTNUT, ALOE, COLLINSONIA CANADENSIS ROOT, VERONICASTRUM VIRGINICUM ROOT, HYDROCHLORIC ACID, STRYCHNOS NUX-VOMICA SEED, PAEONIA OFFICINALIS ROOT, AND SULFURMediNatura Incd7df7d3e-48ad-4f58-aef5-a7bd48d2f1912022-01-05WarningsExact identifier
unii: 70FD1KFU70
FLU TERMINATOR DROPSGELSEMIUM, ZINCUM GLUCONICUM, ZINCUM METALLICUM, ACONITUM NAPELLUS, EUPATORIUM PERFOLIATUM, SULPHUR, PHOSPHORUS, ASCLEPIAS VINCETOXICUM, INFLUENZINUM, ANAS BARBARIAE.Be Well Medical dba Richard Clement Nutrition y Be Well Homeopathicsc818b723-e038-47b0-940a-f2bb7edfd69c2021-12-29WarningsExact identifier
unii: 70FD1KFU70
EAR RXACONITUM NAP, BARYTA CARB, BELLADONNA, CALC CARB, CAPSICUM, CARBO VEG, CAUSTICUM, CHAMOMILLA, FERRUM PHOS, HEPAR SULPH CALC, KALI MUR, LACHESIS, LYCOPODIUM, MERCURIUS SOL, NATRUM MUR, PLANTAGO, PULSATILLA, SILICEA, SULPHUR, VERBASCUMMiami Beach Pediatrics paa8753f88-4b8a-472f-a4bd-f2e9cec836102021-12-29WarningsExact identifier
unii: 70FD1KFU70
Acne Relief GelCALENDULA OFFICINALIS, CHAMOMILLA, BERBERIS AQUAFOLIUM, HAMAMELIS, HEPAR SULPH. CALC. , SULPHUROHM PHARMA INC.43f669ef-2ebd-46c8-adb6-84bea30a7c0b2021-12-29WarningsExact identifier
unii: 70FD1KFU70
Sterile Diluent for TreprostinilWATERDr.Reddy's Laboratories Inc.,33050ee2-519b-1f0b-d4df-9e14dd329c572021-12-23Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Childrens Cold and Cough Grape FlavorONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURWalgreen Company7a2c09e5-0195-138c-e053-2a91aa0ae0a72021-12-21WarningsExact identifier
unii: 70FD1KFU70
GUNA DEFENSECALCIUM SULFIDE - CENTELLA ASIATICA - ECHINACEA ANGUSTIFOLIA WHOLE - ECHINACEA PURPUREA - THUJA OCCIDENTALIS LEAFY TWIG - VINCETOXICUM HIRUNDINARIA ROOT - PHYTOLACCA AMERICANA ROOT - SULFUR -Guna spaaf94b281-be4f-4715-e053-2995a90af1532021-12-15WarningsExact identifier
unii: 70FD1KFU70
GUNA HAY FEVER RELIEFSTRYCHNOS NUX VOMICA SEED - HISTAMINE DIHYDROCHLORIDE - MANGANESE - SCHOENOCAULON OFFICINALE SEED - APIS MELLIFERA - ARSENIC TRIOXIDE - SILVER NITRATE - ONION - EUPHRASIA STRICTA - GALPHIMIA GLAUCA FLOWERING TOP - SULFUR -Guna spab8db4fc6-f235-6f2b-e053-2a95a90a186f2021-12-15WarningsExact identifier
unii: 70FD1KFU70
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.d5c75dc2-9edc-429e-8f25-e5641fe5042f2021-11-23WarningsExact identifier
unii: 70FD1KFU70
CONSTIPATION CPALUMINUM OXIDE, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SULFUR, SODIUM CHLORIDE, MAGNESIUM CHLORIDE, LEAD, SEPIA OFFICINALIS JUICE.Natural Creations, Inc.961b3ddf-41fe-46ed-b5e4-0fd8d9652edf2021-11-15WarningsExact identifier
unii: 70FD1KFU70
SULPHURSULPHURRxhomeo Private Limited d.b.a. Rxhomeo, Inc61a36a56-4e62-4721-81fb-ee8dcd08b4d82021-09-02WarningsExact identifier
unii: 70FD1KFU70
Sterile WaterSTERILE WATERB. Braun Medical Inc.d99f9133-e4d0-4dee-b611-dbc3f918b5472021-08-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERB. Braun Medical Inc.8924e52e-8622-4ed6-a061-1908183e0a182021-08-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FungisodeARSENICUM ALBUM, BERBERIS VULGARIS, CALCAREA CARBONICA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, ECHINACEA PURPUREA, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NITRICUM ACIDUM, OXALICUM ACIDUM, SEPIA OFFICINALIS, SULPHURSeroyal USA55c5dfc4-3757-6ac2-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
HLU PNEUMO DROPSARSENICUM IODATUM, CALCAREA PHOSPHORICA, CARBO VEGETABILIS, ORYCTOLAGUS CUNICULUS LUNG, PHELLANDRIUM AQUATICUM, SILICEA, STANNUM METALLICUM, SULPHUR, THYMUS VULGARISSeroyal USA2f0acce5-aad5-1dd3-e054-00144ff88e882021-07-22WarningsExact identifier
unii: 70FD1KFU70
UNDA 210BOLDO LEAF, CRATAEGUS, LACTUCA VIROSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALISSeroyal USA205b68ed-ff41-3559-e054-00144ff88e882021-07-15WarningsExact identifier
unii: 70FD1KFU70
Post - VaccinationINFLUENZINUM, MORBILLINUM, PERTUSSINUM, ACONITUM NAP., ALUMINA, ANTIMON. TART., ARSENICUM ALB., BAPTISIA, BELLADONNA, BRYONIA, CINCHONA, CROTALUS HORRIDUS, GELSEMIUM, KALI BIC., LACHESIS, LEDUM, MERC. VIV., MEZEREUM, NUX VOM., PHOSPHORUS, PULSATILLA, RHUS TOXICODENDRON, SILICEA, SULPHUR, THUJA OCC., VACCINIUM, APIS MEL., ECHINACEA, HYPERICUMNewton Laboratories, Inc.c67b3a39-ef78-5e81-e053-2a95a90a47862021-07-06WarningsExact identifier
unii: 70FD1KFU70
EyewashEYEWASHGlobal Equipment Companyc4f78121-4668-2e0c-e053-2995a90ab6c62021-06-17WarningsExact identifier
unii: 059QF0KO0R
OHM-INMAACONITUM NAPELLUS, ARANEA DIADEMA, ARNICA MONTANA, ASCLEPIAS VINCETOXICUM, BAPTISIA TINCTORIA, BRYONIA ALBA, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, EUPATORIUM PERFORLIATUM, GELSEMIUM SEMPERVIRENS, HEPAR SULPHURIS CALCAREUM, JUGLANS REGIA, PHYTOLACCA DECANDRA, SANGUINARIA CANADENSIS, SARSAPARILLA, SULPHUR, ZINCUM METALLICUMOHM PHARMA INC.bc8e72c7-b7e6-4d5d-bd37-75202244d4402021-03-25WarningsExact identifier
unii: 70FD1KFU70

Reported adverse events (FAERS/openFDA)#

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