Calc Fluor
Calcium Fluoride
Hyland's Inc.
Human Otc Drug
NDC 54973-2033Calc Fluor also known as Calcium Fluoride is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Calc Fluor is 54973-2033. This drug is available in dosage form of Tablet. The names of the active, medicinal ingredients in Calc Fluor drug includes Calcium Fluoride - 6 [hp_X]/1 . The currest status of Calc Fluor drug is Active.
Drug Information:
| Drug NDC: | 54973-2033 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Calc Fluor |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Calcium Fluoride |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hyland's Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Tablet |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CALCIUM FLUORIDE - 6 [hp_X]/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Jan, 1940 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Hyland's Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0354973203327
|
| UPC stands for Universal Product Code. |
| UNII: | O3B55K4YKI
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 54973-2033-1 | 500 TABLET in 1 BOTTLE (54973-2033-1) | 01 Jan, 1940 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
For colds, hemorrhoids, chapped skin indications relief of symptoms of headcolds with thick, greenish discharge. relieves the symptoms of itching and burning pains due to hemorrhoids. relieves the symptoms of chapped and cracked skin.
Product Elements:
Calc fluor calcium fluoride lactose acacia calcium fluoride fluoride ion off-white
Indications and Usage:
Indications relief of symptoms of headcolds with thick, greenish discharge. relieves the symptoms of itching and burning pains due to hemorrhoids. relieves the symptoms of chapped and cracked skin.
Warnings:
Warnings do not use if imprinted cap band is broken or missing. if symptoms persist for more than 7 days or worsen, contact a licensed health care provider. if you are pregnant or nursing, seek the advice of a licensed health care provider before using this product. keep all medications out of the reach of children.
Do Not Use:
Warnings do not use if imprinted cap band is broken or missing. if symptoms persist for more than 7 days or worsen, contact a licensed health care provider. if you are pregnant or nursing, seek the advice of a licensed health care provider before using this product. keep all medications out of the reach of children.
Dosage and Administration:
Directions adults & children ages 6 - 12: 4 tablets. children ages 2 - 6: 2 tablets. dissolve under tongue 3 times a day. use more frequently (every 15 minutes for up to 8 doses) with acute conditions.
Package Label Principal Display Panel:
Principal display panel - 1000 tablet bottle label homeopathic ndc 54973-2033-2 hyland's ® # 1 calc. fluor. 6x colds, hemorrhoids, chapped skin 1000 tablets label
Further Questions:
Questions? 800.624.9659