| Drug NDC: | 43742-1587 |
| 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: | Bacteria Combination |
| 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: | Adenosinum Triphosphoricum Dinatrum, Malicum Acidum, Natrum Oxalaceticum, Oroticum Acidum, Riboflavinum, Cinnamic Acid, Petroselinum Sativum, Colibacillinum Cum Natrum Muriaticum, Echinacea (angustifolia), Helicobacter Pylori, Mycoplasma Pneumoniae, Proteus (mirabilis), Proteus (vulgaris), Pseudomonas Aeruginosa, Salmonella Typhi Nosode, Enterococcus Faecalis, Streptococcus Mutans, Pneumococcinum, Streptococcus Agalactiae, Legionella Pneumophila, Listeria Monocytogenes, Dysentery Bacillus, Shigella Sonnei, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Deseret Biologicals, Inc. |
| 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: | ADENOSINE PHOSPHATE DISODIUM - 6 [hp_X]/mL CINNAMIC ACID - 6 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 15 [hp_X]/mL ENTEROCOCCUS FAECALIS - 13 [hp_C]/mL ESCHERICHIA COLI - 15 [hp_X]/mL HELICOBACTER PYLORI - 15 [hp_X]/mL LEGIONELLA PNEUMOPHILA - 14 [hp_C]/mL LISTERIA MONOCYTOGENES - 14 [hp_C]/mL MALIC ACID - 6 [hp_X]/mL MYCOPLASMA PNEUMONIAE - 15 [hp_X]/mL Load more... OROTIC ACID MONOHYDRATE - 6 [hp_X]/mL PETROSELINUM CRISPUM - 6 [hp_X]/mL PROTEUS MIRABILIS - 15 [hp_X]/mL PROTEUS MORGANII - 30 [hp_C]/mL PROTEUS VULGARIS - 15 [hp_X]/mL PSEUDOMONAS AERUGINOSA - 15 [hp_X]/mL RIBOFLAVIN - 6 [hp_X]/mL SALMONELLA ENTERICA ENTERICA SEROVAR TYPHI - 17 [hp_X]/mL SHIGELLA DYSENTERIAE - 15 [hp_C]/mL SHIGELLA SONNEI - 15 [hp_C]/mL SODIUM DIETHYL OXALACETATE - 6 [hp_X]/mL STREPTOCOCCUS AGALACTIAE - 14 [hp_C]/mL STREPTOCOCCUS DYSGALACTIAE - 15 [hp_C]/mL STREPTOCOCCUS EQUINUS - 15 [hp_C]/mL STREPTOCOCCUS MUTANS - 13 [hp_C]/mL STREPTOCOCCUS PNEUMONIAE - 13 [hp_C]/mL STREPTOCOCCUS UBERIS - 32 [hp_C]/mL STREPTOCOCCUS VIRIDANS GROUP - 38 [hp_C]/mL |
| 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: | 18 Nov, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 20 Jul, 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: | 07 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Deseret Biologicals, 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: | T1WZ11DSRN U14A832J8D VB06AV5US8 15E04LZ9CT 514B9K0L10 U09W5JOL3Z TJR6ZFY0F0 3O44K14A86 817L1N4CKP JQE470FAD0 Load more... 91532S02AO 1WZA4Y92EX C177VR41DV 56X6LID5ZY 11T9HCO30O Y793W5V55N TLM2976OFR 760T5R8B3O 1EP6R5562J OO358E3009 6CA025Y4FG 2B3763S671 LN0SH02Y5M R2P4NKP3ZK 5C7J33MJJ1 BT6U234YR2 O84V4ZK4BX NNV2379HKR |
| 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 |
|---|---|---|---|---|
| 43742-1587-1 | 30 mL in 1 BOTTLE, DROPPER (43742-1587-1) | 18 Nov, 2019 | 20 Jul, 2025 | 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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