Silicea 6x
Silicon Dioxide
Hyland's Inc.
Human Otc Drug
NDC 54973-4098Silicea 6x also known as Silicon Dioxide is a human otc drug labeled by 'Hyland's Inc.'. National Drug Code (NDC) number for Silicea 6x is 54973-4098. This drug is available in dosage form of Tablet, Soluble. The names of the active, medicinal ingredients in Silicea 6x drug includes Silicon Dioxide - 6 [hp_X]/1 . The currest status of Silicea 6x drug is Active.
Drug Information:
| Drug NDC: | 54973-4098 |
| 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: | Silicea 6x |
| 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: | Silicon Dioxide |
| 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, Soluble |
| 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: | SILICON DIOXIDE - 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: | 06 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 17 Dec, 2025 |
| 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. |
| UNII: | ETJ7Z6XBU4
|
| 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 |
|---|
| 54973-4098-1 | 1 BOTTLE, PLASTIC in 1 CARTON (54973-4098-1) / 100 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC | 06 Dec, 2021 | 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:
Minor skin eruptions, brittle hair or nails
Product Elements:
Silicea 6x silicon dioxide acacia lactose monohydrate silicon dioxide silicon dioxide white to off white
Indications and Usage:
Uses â temporarily relieves: â minor skin eruptions â brittle hair or nails
Warnings:
Warnings stop use and ask a doctor if â symptoms persist for more than 7 days or worsen. â irritation, pain, swelling or redness persists or worsens. if pregnant or breastfeeding ask a health professional before use. keep out of reach of children.
Dosage and Administration:
Directions â use as directed. â adults and children 6 years and over: dissolve 1 tablet under tongue 3 times per day.
Stop Use:
Stop use and ask a doctor if â symptoms persist for more than 7 days or worsen. â irritation, pain, swelling or redness persists or worsens.
Package Label Principal Display Panel:
Package label - 100 tablets bottle carton hyland's naturals⢠cell salt #12 silicea 6x minor skin eruptions* brittle hair & nails* 100 quick-dissolving single tablet doses homeopathic carton
Further Questions:
Questions? www.hylands.com or care@hylands.com