MedPath

Bestmade Natural Products Avena Sat

Avena Sativa Tinc

Approved
Approval ID

36d30eab-9d55-6e1c-e063-6394a90a3e09

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 5, 2025

Manufacturers
FDA

Bestmade Natural Products

DUNS: 047124582

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Avena Sativa

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82969-5120
Product Classification
G
Generic Name
Avena Sativa
Product Specifications
Route of AdministrationORAL
Effective DateJune 5, 2025
FDA Product Classification

INGREDIENTS (3)

AVENA SATIVA FLOWERING TOPActive
Quantity: 1 [hp_M] in 1 mL
Code: MA9CQJ3F7F
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.7 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
WATERInactive
Quantity: 0.3 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/1/2025

Entire Package Label

Avena Sat

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/1/2025

Use: Temporarily relieves sleeplessness with nervous exhaustion and weakness.*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/1/2025

Dosage Instructions: 10 drops in a spoon of water 3 times a day. For people under 100lb: use half a dose or take as prescribed.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/1/2025

Active Ingredient: Avena Sativa Ø (HPUS)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/1/2025

Inactive Ingredient: Alcohol base to preserve product.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/1/2025

Use: Temporarily relieves sleeplessness with nervous exhaustion and weakness.*

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/1/2025

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

WARNINGS SECTION

LOINC: 34071-1Updated: 6/1/2025

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms. Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.

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Bestmade Natural Products Avena Sat - FDA Drug Approval Details