FDA.reportPublic FDA data

Allergies Nightshades

Manufacturer
King Bio Inc.
Effective date
2016-04-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:40

Label at a glance#

ProductAllergies Nightshades
Active ingredientALUMINUM, ARSENIC TRIOXIDE, ATROPA BELLADONNA, HISTAMINE DIHYDROCHLORIDE, GOLDENSEAL, MANDRAGORA OFFICINARUM ROOT, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SOLANINE, SOLANUM NIGRUM WHOLE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Aluminium metallicum, Arsenicum album, Belladonna, Histaminum hydrochloricum, Hydrastis canadensis, Mandragora officinarum, Nux vomica, Phosphorus, Pulsatilla, Solaninum, Solanum nigrum​. Equal volumes of each ingredient in 12X, 24X, 30C, LM1, LM2, LM3, LM5 potencies.

INDICATIONS & USAGE SECTION

Uses for symptoms from potatoes, tomatoes, peppers and other nightshade foods: joint pain, stiffness, headaches, dizziness, diarrhea, mild depression, nausea, skin irritations.

​

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12: 2 sprays 3 times per day.
  • Children 2 mo-2yr: 1 spray 3 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

OTC - PURPOSE SECTION

Uses for symptoms from potatoes, tomatoes, peppers and other nightshade foods:

  • joint pain
  • stiffness
  • headaches
  • dizziness
  • diarrhea
  • mild depression
  • nausea
  • skin irritations

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-2502-22020-01-31C16284748780-19d75b9d0-77b0-f424-e053-dadaa90a57ceAllergies: Nightshades™

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-2502-2Allergies Nightshades59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-2502ALLERGIES NIGHTSHADES (ALUMINIUM METALLICUM, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, MANDRAGORA OFFICINARUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, SOLANINUM, SOLANUM NIGRUM) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20160401_746ea3ee-a88b-4699-924d-099c6e6ad86c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-250257955-2502-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALUMINUMCPD4NFA903ACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
GOLDENSEALZW3Z11D0JVACTIB
MANDRAGORA OFFICINARUM ROOTI2XCB174VBACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SOLANINE3FYV8328OKACTIB
SOLANUM NIGRUM WHOLE0FMD6WV47MACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
c01646e2-9252-4cc2-b8ae-aad9cfa44fd6746ea3ee-a88b-4699-924d-099c6e6ad86c2016-04-01WarningsExact identifier
spl id: c01646e2-9252-4cc2-b8ae-aad9cfa44fd6
spl set id: 746ea3ee-a88b-4699-924d-099c6e6ad86c

Reported adverse events (FAERS/openFDA)#

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