FDA.reportPublic FDA data

Dairy-Grain-Nightshades

Manufacturer
Newton Laboratories, Inc.
Effective date
2025-02-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:31:49

Label at a glance#

ProductDairy-Grain-Nightshades
Active ingredientCORN SILK, COW MILK, SOLIDAGO VIRGAUREA FLOWERING TOP, SILVER NITRATE, ATROPA BELLADONNA, TOBACCO LEAF, SEPIA OFFICINALIS JUICE, PHOSPHORUS, BAPTISIA TINCTORIA ROOT, LYCOPODIUM CLAVATUM SPORE, SODIUM CHLORIDE, ANEMONE PULSATILLA, LACTOSE, UNSPECIFIED FORM, PODOPHYLLUM, VERBASCUM THAPSUS, SOLANUM NIGRUM WHOLE, IRIS VERSICOLOR ROOT, AVENA SATIVA FLOWERING TOP, CAPSICUM, CENTAUREA BENEDICTA, CINCHONA OFFICINALIS BARK, ANTIMONY TRISULFIDE, TOXICODENDRON PUBESCENS LEAF, HYOSCYAMUS NIGER, ELYMUS REPENS ROOT, IPECAC, LACHESIS MUTA VENOM, SOLANUM DULCAMARA TOP, BRYONIA ALBA ROOT, FAGOPYRUM ESCULENTUM, GELSEMIUM SEMPERVIRENS ROOT, DATURA STRAMONIUM, USTILAGO MAYDIS, SOLANUM LYCOPERSICUM, ARSENIC TRIOXIDE, SOLANUM TUBEROSUM, SACCHAROMYCES CEREVISIAE, CLAVICEPS PURPUREA SCLEROTIUM
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with sensitivity to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed 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 Iris versicolor 6x, Solidago virgaurea 6x, Antimonium crudum 15x, Argentum nitricum 15x, Arsenicum album 15x, Avena sativa 15x, Baptisia tinctoria 15x, Belladonna 15x, Bryonia 15x, Capsicum annuum 15x, Carduus benedictus 15x, Cinchona officinalis 15x, Dulcamara 15x, Fagopyrum esculentum 15x, Gelsemium sempervirens 15x, Hyoscyamus niger 15x, Ipecacuanha 15x, Lac vaccinum 15x, Lachesis mutus 15x, Lycopodium clavatum 15x, Natrum muriaticum 15x, Phosphorus 15x, Podophyllum peltatum 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Saccharum lactis 15x, Secale cornutum 15x, Sepia 15x, Stramonium 15x, Tabacum 15x, Triticum repens 15x, Ustilago maidis 15x, Verbascum thapsus 15x, Lycopersicum esculentum 16x, Solanum nigrum 16x, Solanum tuberosum 16x, Stigmata maidis 16x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with sensitivity to dairy, grain and nightshade foods such as bloating, headache, indigestion, itching and eruptions.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 800.448.7256

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

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
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6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2416-1Dairy-Grain-Nightshades30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2416DAIRY-GRAIN-NIGHTSHADES (IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20250209_9ba83c60-35be-181a-e053-2a95a90a9895.zip

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-241655714-2416-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
CORN SILK7D3VB244UXACTIB
COW MILK917J3173FTACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
SILVER NITRATE95IT3W8JZEACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
TOBACCO LEAF6YR2608RSUACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
PHOSPHORUS27YLU75U4WACTIB
BAPTISIA TINCTORIA ROOT5EF0HWI5WUACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GACTIB
PODOPHYLLUM2S713A4VP3ACTIB
VERBASCUM THAPSUSC9TD27U172ACTIB
SOLANUM NIGRUM WHOLE0FMD6WV47MACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
CAPSICUM00UK7646FGACTIB
CENTAUREA BENEDICTA6L5ZL09795ACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
HYOSCYAMUS NIGER4WRK2153H3ACTIB
ELYMUS REPENS ROOT3IXW0F6P8WACTIB
IPECAC62I3C8233LACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SOLANUM DULCAMARA TOPKPS1B1162NACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
FAGOPYRUM ESCULENTUMB10M69172NACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
USTILAGO MAYDIS4K7Z7K7SWGACTIB
SOLANUM LYCOPERSICUM0243Q4990LACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
SOLANUM TUBEROSUM2A8I57T4MXACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CLAVICEPS PURPUREA SCLEROTIUM01G9XEA93NACTIB

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
Dairy-Grain-NightshadesIRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.Newton Laboratories, Inc.9ba83c60-35be-181a-e053-2a95a90a98952025-02-06WarningsExact identifier
ndc (package): 55714-2416-1
ndc (product): 55714-2416
ndc11 (package): 55714241601
spl id: 2d816496-ca79-4e1a-e063-6394a90ae5bc
spl set id: 9ba83c60-35be-181a-e053-2a95a90a9895

Reported adverse events (FAERS/openFDA)#

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