NDC 51393-5005 Heartburn

Garlic, Berberis Vulgaris Root, Calendula Officinalis Flowering Top, Iris Versicolor Root, Ginger, And Valerian

NDC Product Code 51393-5005

NDC CODE: 51393-5005

Proprietary Name: Heartburn What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Garlic, Berberis Vulgaris Root, Calendula Officinalis Flowering Top, Iris Versicolor Root, Ginger, And Valerian What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 51393 - Forces Of Nature

NDC 51393-5005-1

Package Description: 1 BOTTLE, DISPENSING in 1 CARTON > 10 mL in 1 BOTTLE, DISPENSING

NDC Product Information

Heartburn with NDC 51393-5005 is a a human over the counter drug product labeled by Forces Of Nature. The generic name of Heartburn is garlic, berberis vulgaris root, calendula officinalis flowering top, iris versicolor root, ginger, and valerian. The product's dosage form is solution/ drops and is administered via sublingual form.

Labeler Name: Forces Of Nature

Dosage Form: Solution/ Drops - A solution which is usually administered in a drop-wise fashion.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Heartburn Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • GARLIC 89 [hp_C]/100mL
  • BERBERIS VULGARIS ROOT 6 [hp_X]/100mL
  • CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X]/100mL
  • IRIS VERSICOLOR ROOT 12 [hp_C]/100mL
  • GINGER 89 [hp_C]/100mL
  • VALERIAN 12 [hp_C]/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • PEPPERMINT OIL (UNII: AV092KU4JH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Sublingual - Administration beneath the tongue.
  • Sublingual - Administration beneath the tongue.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Forces Of Nature
Labeler Code: 51393
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 10-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Heartburn Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Manufactured & Distributed by Forces of Nature, Inc21787 8th St East #3A Sonoma, CA 95476 USA

Otc - Purpose

Active ingredientsPurposeAllium sativumUSDA Certified Organic 89CFor Heartburn, Indigestion, Burning BurpsBerberis vulgaris 6XRemedy for HeartburnCalendula officinalis 6XRemedy for HeartburnIris versicolor 12CFor Burning, Sour BelchesZingiber officinale 89CFor Indigestion/Sour Acidic BurpsValeriana officinalis 12CFor Heartburn with Acid

Uses

To help calm acid indigestion, upset stomach, and heartburn.

Warnings

For oral (sublingual) use.

Otc - Ask Doctor

Ask a doctor before use in children under 6 years of age.

Otc - Stop Use

Stop use and ask doctor if symptoms persist for more than 3 days or worsen.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding ask a doctor before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

For humans. Use as needed. For best results, use at the first sign of symptoms. Shake well before use.

Adults/Children Over 12

Take 6-9 drops under the tongue. Repeat as needed when experiencing symptoms.

Other Information

  • Keep in cool dark place

Inactive Ingredients

Distilled Water, Grain Alcohol, Peppermint Oil

* Please review the disclaimer below.