FDA.reportPublic FDA data

Detox

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:05:40

Label at a glance#

ProductDetox
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, Silybum Marianum Seed, Cynara Scolymus Leaf, Solidago Virgaurea Flowering Top
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Detox  Formulated for liver and kidney functions and for symptoms associated with toxicity such as fatigue, headaches and sluggish elimination.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY -  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) at bedtime or as directed by a healthcare professional.  Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Uricum ac. 15x, Benzoicum ac. 10x, Berber. vulg. 10x, Bryonia 10x, Cantharis 10x, Carduus ben. 10x, Ceanothus 10x, Chelidonium maj. 10x, Chionanthus 10x, Cinchona 10x, Dioscorea 10x, Dolichos 10x, Iris vers. 10x, Juniperus com. 10x, Nux vom. 10x, Ptelea 10x, Taraxacum 10x, Carduus mar. 3x, Cynara 3x, Solidago 3x, Taraxacum 3x.

OTC - PURPOSE SECTION

Formulated for liver and kidney functions and 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 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, 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
55714-8000-12020-01-31C16284748780-19d75b9d0-ff7f-f424-e053-dadaa90a57ceDetox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-8000-1Detox29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-8000DETOX (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) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20140429_bf336475-d647-d6d8-2990-73a8b88f884b.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
Centaurea BenedictaACTIVE INGREDIENT6L5ZL097951
Chelidonium MajusACTIVE INGREDIENT7E889U5RNN1
Chionanthus Virginicus BarkACTIVE INGREDIENTS9Y4B22U2E1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Cynara Scolymus LeafACTIVE INGREDIENTB71UA545DE1
Dioscorea Villosa TuberACTIVE INGREDIENTIWY3IWX2G81
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Juniper BerryACTIVE INGREDIENTO84B5194RL1
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
Centaurea BenedictaACTIVE MOIETY6L5ZL097951
Chelidonium MajusACTIVE MOIETY7E889U5RNN1
Chionanthus Virginicus BarkACTIVE MOIETYS9Y4B22U2E1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Cynara Scolymus LeafACTIVE MOIETYB71UA545DE1
Dioscorea Villosa TuberACTIVE MOIETYIWY3IWX2G81
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Juniper BerryACTIVE MOIETYO84B5194RL1
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
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-800055714-8000-1

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
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
Silybum Marianum SeedU946SH95EEACTIB
Cynara Scolymus LeafB71UA545DEACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
fd162601-1b55-1a68-6820-d9707a7fac8dbf336475-d647-d6d8-2990-73a8b88f884b2014-04-15WarningsExact identifier
spl id: fd162601-1b55-1a68-6820-d9707a7fac8d
spl set id: bf336475-d647-d6d8-2990-73a8b88f884b

Reported adverse events (FAERS/openFDA)#

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