FDA.reportPublic FDA data

Drainer

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:35

Label at a glance#

ProductDrainer
Active ingredientBenzoic Acid, Berberis Vulgaris Root Bark, Bryonia Alba Root, Lytta Vesicatoria, Cnicus Benedictus, Ceanothus Americanus Leaf, Chelidonium Majus, Chionanthus Virginicus Bark, Cinchona Officinalis Bark, Dioscorea Villosa Tuber, Mucuna Pruriens Fruit Trichome, Iris Versicolor Root, Juniper, Strychnos Nux-vomica Seed, Ptelea Trifoliata Bark, Taraxacum Officinale, Uric Acid, Silybum Marianum Seed, Cynara Scolymus Leaf, Solidago Virgaurea Flowering Top
Label structure9 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Drainer  Formulated for liver, kidney and colon functions and for symptoms associated with toxic conditions.   

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) at bedtime or as directed by a healthcare professional. 

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Benzoicum acidum 15x, Berber. vulg. 15x, Bryonia 15x, Cantharis 15x, Carduus benedictus 15x, Ceanothus 15x, Chelidonium majus 15x, Chionanthus virginica 15x, Cinchona 15x, Dioscorea 15x, Dolichos 15x, Iris versicolor 15x, Juniperus com.15x, Nux vom. 15x, Ptelea 15x, Taraxacum 15x, Uricum acidum 15x,Carduus mar. 3x, Cynara scolymus 3x,  Solidago 3x, Taraxacum 3x.              

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 -Conyers, GA 30012
Questions?  1.800.448.7256  

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.       

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.           

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.     

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4400-12020-01-31C16284748780-19d75b9d0-746e-f424-e053-dadaa90a57ceDrainer
55714-4400-22020-01-31C16284748780-19d75b9d0-746e-f424-e053-dadaa90a57ceDrainer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4400-1Drainer29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-4400-2Drainer59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4400DRAINER (BENZOIC ACIDUM, BERBERIS VULG., BRYONIA, CANTHARIS,CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM., PTELEA, TARAXACUM, URICUM ACIDUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO, TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20120327_1944fe7b-8d1f-bde9-c67c-486dae25ba63.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM1
Berberis Vulgaris Root BarkACTIVE INGREDIENT1TH8Q20J0U1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Ceanothus Americanus LeafACTIVE INGREDIENT25B1Y14T8N1
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Chionanthus Virginicus BarkACTIVE INGREDIENTS9Y4B22U2E1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Cnicus BenedictusACTIVE INGREDIENT6L5ZL097951
Cynara Scolymus LeafACTIVE INGREDIENTB71UA545DE1
Dioscorea Villosa TuberACTIVE INGREDIENTIWY3IWX2G81
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
JuniperACTIVE INGREDIENT464910T5N91
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT1
Mucuna Pruriens Fruit TrichomeACTIVE INGREDIENT3E271BSI0C1
Ptelea Trifoliata BarkACTIVE INGREDIENT5KQR6FTT0D1
Silybum Marianum SeedACTIVE INGREDIENTU946SH95EE1
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3751
Uric AcidACTIVE INGREDIENT268B43MJ251
Benzoic AcidACTIVE MOIETY8SKN0B0MIM1
Berberis Vulgaris Root BarkACTIVE MOIETY1TH8Q20J0U1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Ceanothus Americanus LeafACTIVE MOIETY25B1Y14T8N1
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Chionanthus Virginicus BarkACTIVE MOIETYS9Y4B22U2E1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Cnicus BenedictusACTIVE MOIETY6L5ZL097951
Cynara Scolymus LeafACTIVE MOIETYB71UA545DE1
Dioscorea Villosa TuberACTIVE MOIETYIWY3IWX2G81
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
JuniperACTIVE MOIETY464910T5N91
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT1
Mucuna Pruriens Fruit TrichomeACTIVE MOIETY3E271BSI0C1
Ptelea Trifoliata BarkACTIVE MOIETY5KQR6FTT0D1
Silybum Marianum SeedACTIVE MOIETYU946SH95EE1
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Taraxacum OfficinaleACTIVE MOIETY39981FM3751
Uric AcidACTIVE MOIETY268B43MJ251

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-440055714-4400-1, 55714-4400-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoic Acid8SKN0B0MIMACTIB
Berberis Vulgaris Root Bark1TH8Q20J0UACTIB
Bryonia Alba RootT7J046YI2BACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Cnicus Benedictus6L5ZL09795ACTIB
Ceanothus Americanus Leaf25B1Y14T8NACTIB
Chelidonium Majus7E889U5RNNACTIB
Chionanthus Virginicus BarkS9Y4B22U2EACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Dioscorea Villosa TuberIWY3IWX2G8ACTIB
Mucuna Pruriens Fruit Trichome3E271BSI0CACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Juniper464910T5N9ACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Ptelea Trifoliata Bark5KQR6FTT0DACTIB
Taraxacum Officinale39981FM375ACTIB
Uric Acid268B43MJ25ACTIB
Silybum Marianum SeedU946SH95EEACTIB
Cynara Scolymus LeafB71UA545DEACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Taraxacum Officinale39981FM375ACTIB

Source Document#

Source XML

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
e821e739-51c3-3c48-421b-2c8230efefd61944fe7b-8d1f-bde9-c67c-486dae25ba632011-06-01WarningsExact identifier
spl id: e821e739-51c3-3c48-421b-2c8230efefd6
spl set id: 1944fe7b-8d1f-bde9-c67c-486dae25ba63

Reported adverse events (FAERS/openFDA)#

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