NDC 68647-165 Oral Soothe

  1. Labeler Index
  2. Feelgood Health
  3. NDC: 68647-165 Oral Soothe

NDC Product Code 68647-165

NDC CODE: 68647-165

Proprietary Name: Oral Soothe 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
  • This product is used as relieves pain, crankiness and crying during teething

Product Characteristics

Color(s):
WHITE (C48325 - WHITE SUCROSE GRANULES)

NDC Code Structure

NDC 68647-165-10

Package Description: 20000 mg in 1 BOTTLE, GLASS

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Oral Soothe with NDC 68647-165 is product labeled by Feelgood Health. The product's dosage form is and is administered via form.

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.
  • SUCROSE (UNII: C151H8M554)

Product Labeler Information

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

Labeler Name: Feelgood Health
Labeler Code: 68647
Start Marketing Date: 01-01-2010 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: 12-31-2017 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Oral Soothe Product Label Images

Oral Soothe 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

Otc - Purpose

Relieves
pain, crankiness and crying during teething

Indications & Usage

Indications:  Soothing homeopathic remedy for teething in
babies and children.

Dosage & Administration

Dosage: Sprinkle
1 pinch on the tongue when needed. Repeat after 20 minutes for up to 10 doses
if needed.

General Precautions

Caution: If
symptoms persist or worsen, a health care professional should be consulted.
Keep this and all medicines from the reach of children.

Otc - Active Ingredient

Ingredients: Each dose contains
equal parts of Passiflora (3X) (HPUS), Chamomilla (3X) (HPUS), Calc fluor (6X)
(HPUS), Calc phos (6X) (HPUS), Chamomilla (6C) (HPUS)

Inactive Ingredient

Sucrose (inactive ingredient).

Warnings

Contains no gluten,
artificial flavors, colors or preservatives.Safe for all ages.

Information For Patients

All Native Remedies health products are especially
formulated by experts in the field of natural health and are manufactured
according to the highest pharmaceutical standards for maximum safety and
effectiveness. For more information, visit us at www.nativeremedies.comDistributed by Native Remedies, LLC6531 Park of Commerce Blvd.Suite 160Boca Raton, FL 33487 Phone: 1.877.289.1235 International: + 1.561.999.8857The letters HPUS
indicate that the component(s) in this product is (are) officially monographed
in the Homeopathic Pharmacopoeia of the United States.

Otc - Keep Out Of Reach Of Children

Keep this and all medicines from the reach of children.

* Please review the disclaimer below.