NDC 54973-4072 Calc Fluor

Calcium Fluoride

NDC Product Code 54973-4072

NDC CODE: 54973-4072

Proprietary Name: Calc Fluor 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: Calcium Fluoride 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.

Product Characteristics

WHITE (C48325)
Shape: ROUND (C48348)
9 MM
Score: 1

NDC Code Structure

NDC 54973-4072-1

Package Description: 50 TABLET in 1 BOTTLE, PLASTIC

NDC 54973-4072-2

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON > 100 TABLET in 1 BOTTLE, PLASTIC

NDC Product Information

Calc Fluor with NDC 54973-4072 is a a human over the counter drug product labeled by Hyland's. The generic name of Calc Fluor is calcium fluoride. The product's dosage form is tablet and is administered via oral form.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

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.

Calc Fluor 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.

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.

  • ACACIA (UNII: 5C5403N26O)

Administration Route(s)

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

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

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

Labeler Name: Hyland's
Labeler Code: 54973
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: 12-06-2021 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: 12-31-2022 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 - NO 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.

Calc Fluor Product Label Images

Calc Fluor 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

Temporarily relieves cold symptoms, chapped or cracked skin, itching or pain due to hemorrhoids

Active Ingredients

Active ingredientsPurposeCalcarea Fluorica 6X HPUScold symptoms, hemorrhoids, chapped and cracked skin"HPUS" is the Homeopathic Pharmacopoeia of the United States.


■Temporarily relieves:

■ cold symptoms ■ chapped or cracked skin

■ itching or pain due to hemorrhoids

Sore Throat Warning

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,

consult a doctor promptly.

Ask A Doctor Before Use If You Have

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be

a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop Use And Ask A Doctor If

■ bleeding occurs. ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops.■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If Pregnant Or Breastfeeding

Ask a health professional before use.


■ Use as directed.

■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.

Inactive Ingredients

Acacia Gum, Lactose.


Www.hylands.com or (800) 624-9659

Package Label - 2 X 50 Count Bottles Carton


* Please review the disclaimer below.