FDA.reportPublic FDA data

Drainage

Manufacturer
Xymogen | Newton Laboratories, Inc.
Effective date
2020-05-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:08

Label at a glance#

ProductDrainage
Active ingredientCYNARA SCOLYMUS LEAF, BENZOIC ACID, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CENTAUREA BENEDICTA, MILK THISTLE, CEANOTHUS AMERICANUS LEAF, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS BARK, DIOSCOREA VILLOSA TUBER, CHIONANTHUS VIRGINICUS BARK, MUCUNA PRURIENS FRUIT TRICHOME, IRIS VERSICOLOR ROOT, JUNIPER BERRY, STRYCHNOS NUX-VOMICA SEED, PTELEA TRIFOLIATA BARK, TARAXACUM OFFICINALE, URIC ACID, SOLIDAGO VIRGAUREA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination..

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) at bedtime or as directed by a healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x, Benzoicum ac. 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Carduus ben. 15x, Carduus mar. 15x, Ceanothus 15x, Chelidonium maj. 15x, Chionanthus 15x, Cinchona 15x, Dioscorea 15x, Dolichos 15x, Iris vers. 15x, Juniperus com. 15x, Nux. vom. 15x, Ptelea 15x, Taraxacum 15x, Uricum ac. 15x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.xymogen.com - Questions? 800-647-6100

Xymogen

6900 Kingspointe Pkwy.

Orlando, FL 32819

WARNINGS SECTION

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69028-0003-1Drainage30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69028-0003DRAINAGE (CYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.) LIQUID [XYMOGEN]1Current NDC, Legacy NDC, 1 package rows20200509_a526f4ac-1630-c122-e053-2995a90a6a27.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69028-000369028-0003-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYNARA SCOLYMUS LEAFB71UA545DEACTIB
BENZOIC ACID8SKN0B0MIMACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
MILK THISTLEU946SH95EEACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
DIOSCOREA VILLOSA TUBERIWY3IWX2G8ACTIB
CHIONANTHUS VIRGINICUS BARKS9Y4B22U2EACTIB
MUCUNA PRURIENS FRUIT TRICHOME3E271BSI0CACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
JUNIPER BERRYO84B5194RLACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PTELEA TRIFOLIATA BARK5KQR6FTT0DACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
URIC ACID268B43MJ25ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB

Source Document#

Source XML · Source PDF

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DrainageCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
ndc (package): 69028-0003-1
ndc (product): 69028-0003
ndc11 (package): 69028000301
spl id: a526f439-a9d4-c1c9-e053-2995a90ac78d
spl set id: a526f4ac-1630-c122-e053-2995a90a6a27

Reported adverse events (FAERS/openFDA)#

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