FDA.reportPublic FDA data

NativeRemedies® BrightSpark™ Tablets

Manufacturer
Silver Star Brands | OHM Pharma, Inc.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:29:58

Label at a glance#

ProductBrightspark
Active ingredientSILVER NITRATE, VERATRUM ALBUM ROOT, ARSENIC TRIIODIDE, HYOSCYAMUS NIGER LEAF
Label structure10 sections

Indications and uses

Uses*: Homeopathic remedy for distractibility, mood, and restlessness; assists with concentration. *Claims based on traditional homeopathic practice, not accepted medical evidence. Not evaluated by the FDA.

Dosage and administration

Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. For all ages: Take 2 tablets 3 times daily on an empty stomach when possible. Initial dose only: Take 1 tablet every hour for 6 hours.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

HPUS Active Ingredients: Each tablet contains equal parts of: Arg nit 6C, Arsenicum iod 30C, Hyoscyamus 30C, Veratrum alb 30C.

Uses*

INDICATIONS & USAGE SECTION

Uses*: Homeopathic remedy for distractibility, mood, and restlessness; assists with concentration.

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not evaluated by the FDA.

Warnings

WARNINGS SECTION

Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. For all ages: Take 2 tablets 3 times daily on an empty stomach when possible.

Initial dose only: Take 1 tablet every hour for 6 hours.

OTHER SAFETY INFORMATION

Tamper resistant for your proection. Use only if saftey seal is intact.

Contains no artificial flavors or colorants. No gluten added. Lactose-free.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Magnesium stearat, Maltodextrin, Sucrose.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medication out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Relieves hyperactivity distractibility & impulsiveness.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BrightSpark labelBrightSpark label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-358-802023-12-25C16284748780-1f386c649-dff4-0266-e053-dadaa90a7c1aNativeRemedies® BrightSpark™ Tablets
68703-358-802023-01-30C16284748780-1f386c649-dff4-0266-e053-dadaa90a7c1aNativeRemedies® BrightSpark™ Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68703-358-80Brightspark180 in 1 BOTTLE, GLASSTABLET1804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68703-358BRIGHTSPARK (ARG NIT, ARSENICUM IOD, HYOSCYAMUS, VERATRUM ALB) TABLET [SILVER STAR BRANDS]4Current NDC, Legacy NDC, 1 package rows20250103_b6c50a09-7c13-e1c5-e053-2a95a90a0610.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-35868703-358-80

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER NITRATE95IT3W8JZEACTIB
VERATRUM ALBUM ROOTQNS6W5US1ZACTIB
MALTODEXTRIN7CVR7L4A2DIACT
MAGNESIUM STEARATE70097M6I30IACT
ARSENIC TRIIODIDE3029988O2TACTIB
HYOSCYAMUS NIGER LEAF32IT7G8BAWACTIB
SUCROSEC151H8M554IACT

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
BrightsparkARG NIT, ARSENICUM IOD, HYOSCYAMUS, VERATRUM ALBSilver Star Brandsb6c50a09-7c13-e1c5-e053-2a95a90a06102025-01-01WarningsExact identifier
ndc (package): 68703-358-80
ndc (product): 68703-358
ndc11 (package): 68703035880
spl id: 2ab10b12-68ed-3af8-e063-6294a90af21f
spl set id: b6c50a09-7c13-e1c5-e053-2a95a90a0610

Reported adverse events (FAERS/openFDA)#

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