| Drug NDC: | 61727-338 |
| 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: | Ez-detox Super Drainage Formula |
| 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: | Aesculus Hippocastanum Bark,antimony Trisulfide,silver Nitrate,arnica Montana,berberis Vulgaris Whole,activated Charcoal,ceanothus Americanus Whole,cholesterol,cinchona Bark,cynara Scolymus Leaf,equisetum Arvense Top,conyza Canadensis,fucus Vesiculosus,ginkgo,hamamelis Virginiana Leaf,chamaelirium Luteum Root,goldenseal,arctium Lappa Root,lespedeza Capitata Flowering Top,ranunculus Bulbosus,daikon,robinia Pseudoacacia Bark,taraxacum Palustre Root,viburnum Prunifolium Bark,vitis Vinifera Whole |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Homeocare Laboratories |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| 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: | ACTIVATED CHARCOAL - 9 [hp_X]/50mL AESCULUS HIPPOCASTANUM BARK - 6 [hp_X]/50mL ANTIMONY TRISULFIDE - 10 [hp_X]/50mL ARCTIUM LAPPA ROOT - 6 [hp_X]/50mL ARNICA MONTANA - 6 [hp_X]/50mL BERBERIS VULGARIS WHOLE - 6 [hp_X]/50mL CEANOTHUS AMERICANUS WHOLE - 6 [hp_X]/50mL CHAMAELIRIUM LUTEUM ROOT - 6 [hp_X]/50mL CHOLESTEROL - 10 [hp_X]/50mL CINCHONA BARK - 8 [hp_X]/50mL Load more... CONYZA CANADENSIS - 6 [hp_X]/50mL CYNARA SCOLYMUS LEAF - 6 [hp_X]/50mL DAIKON - 6 [hp_X]/50mL EQUISETUM ARVENSE TOP - 6 [hp_X]/50mL FUCUS VESICULOSUS - 6 [hp_X]/50mL GINKGO - 10 [hp_X]/50mL GOLDENSEAL - 6 [hp_X]/50mL HAMAMELIS VIRGINIANA LEAF - 6 [hp_X]/50mL LESPEDEZA CAPITATA FLOWERING TOP - 6 [hp_X]/50mL RANUNCULUS BULBOSUS - 4 [hp_X]/50mL ROBINIA PSEUDOACACIA BARK - 10 [hp_X]/50mL SILVER NITRATE - 10 [hp_X]/50mL TARAXACUM PALUSTRE ROOT - 6 [hp_X]/50mL VIBURNUM PRUNIFOLIUM BARK - 6 [hp_X]/50mL VITIS VINIFERA WHOLE - 6 [hp_X]/50mL |
| 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 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: | 09 Jul, 2012 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 21 Jun, 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. | |
| Manufacturer Name: | Homeocare Laboratories |
| 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: | 0361727338501 |
| UPC stands for Universal Product Code. | |
| UNII: | 2P3VWU3H10 7U76MXL14N F79059A38U 597E9BI3Z3 O80TY208ZW 492B79913J 8AD0I300BR DQV54Y5H3U 97C5T2UQ7J 292E43P4I9 Load more... B71UA545DE 86R5J6D01D 1DP6Y6B65Z 535G2ABX9M 19FUJ2C58T ZW3Z11D0JV T07U1161SV F930LFZ4LF AEQ8NXJ0MB 7TPC058OWY 95IT3W8JZE GCZ4W7077C J411UTU0HN 22E66I250J |
| 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. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 61727-338-50 | 50 mL in 1 BOTTLE (61727-338-50) | 09 Jul, 2012 | 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. | ||||
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