FDA.reportPublic FDA data

Detoxifier

Manufacturer
Newton Laboratories, Inc.
Effective date
2024-03-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:16

Label at a glance#

ProductDetoxifier
Active ingredientURIC ACID, BENZOIC ACID, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, LYTTA VESICATORIA, CENTAUREA BENEDICTA, CEANOTHUS AMERICANUS LEAF, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICUS BARK, CINCHONA OFFICINALIS BARK, DIOSCOREA VILLOSA TUBER, MUCUNA PRURIENS FRUIT TRICHOME, IRIS VERSICOLOR ROOT, JUNIPER BERRY, STRYCHNOS NUX-VOMICA SEED, PTELEA TRIFOLIATA BARK, TARAXACUM OFFICINALE, MILK THISTLE, CYNARA SCOLYMUS LEAF, 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 health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Cynara 6x, Solidago 6x, Taraxacum 6x, Benzoicum acidum 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus benedictus 10x, Carduus mar. 10x, Ceanothus 10x, Chelidonium majus 10x, Chionanthus virginica 10x, Cinchona 10x, Dioscorea 10x, Dolichos 10x, Iris versicolor 10x, Juniperus com. 10x, Ptelea 10x, Taraxacum 10x, Nux vom. 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%

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.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

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
55714-2559-0Detoxifier15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2559-1Detoxifier30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2559-2Detoxifier50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2559DETOXIFIER (URICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO,TARAXACUM) LIQUID [NEWTON LABORATORIES, INC.]3Current NDC, Legacy NDC, 3 package rows20240308_9af2f55c-f5b5-6fe9-e053-2a95a90ace0c.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
55714-255955714-2559-1, 55714-2559-2, 55714-2559-0

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

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
DetoxifierURICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGO,TARAXACUMNewton Laboratories, Inc.9af2f55c-f5b5-6fe9-e053-2a95a90ace0c2024-03-07WarningsExact identifier
ndc (package): 55714-2559-1
ndc (package): 55714-2559-2
ndc (package): 55714-2559-0
ndc (product): 55714-2559
ndc11 (package): 55714255900
ndc11 (package): 55714255902
ndc11 (package): 55714255901
spl id: 13165365-43f9-3c24-e063-6394a90a89cd
spl set id: 9af2f55c-f5b5-6fe9-e053-2a95a90ace0c

Reported adverse events (FAERS/openFDA)#

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