| Drug NDC: | 43742-0579 |
| 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: | Dairy Allergen Mix |
| 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, Apiolum, Benzoicum Acidum, Cholinum, Cinnamic Acid, Coumarinum, Eugenol, Folic Acid, Folliculinum, Formalinum, Gaba (gamma-aminobutyric Acid), Histaminum Hydrochloricum, L-asparagine (monohydrate), Lac Defloratum, Lac Vaccinum, Menadione, Oophorinum (suis), Phenyl Isothiocyanate, Quercetin, Rutin, Saccharum Lactis, Ileum (suis), Jejunum (suis), Stomach (suis), Sarcolacticum Acidum, Lac Caninum, Lac Felinum, Lac Humanum, Piperine, Calcarea Carbonica |
| 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: | .GAMMA.-AMINOBUTYRIC ACID - 6 [hp_X]/mL ACTIVATED CHARCOAL - 6 [hp_C]/mL ADENOSINE TRIPHOSPHATE DISODIUM - 4 [hp_X]/mL APIOLE (PARSLEY) - 6 [hp_X]/mL ASPARAGINE MONOHYDRATE - 6 [hp_X]/mL BENZOIC ACID - 6 [hp_X]/mL CALCIUM CITRATE - 6 [hp_C]/mL CALCIUM FLUORIDE - 6 [hp_C]/mL CALCIUM GLUCONATE - 6 [hp_C]/mL CANIS LUPUS FAMILIARIS MILK - 30 [hp_X]/mL Load more... CHOLINE HYDROXIDE - 6 [hp_X]/mL CINNAMIC ACID - 6 [hp_X]/mL COUMARIN - 6 [hp_X]/mL COW MILK - 6 [hp_X]/mL ESTRONE - 6 [hp_X]/mL EUGENOL - 6 [hp_X]/mL FELIS CATUS MILK - 30 [hp_X]/mL FOLIC ACID - 6 [hp_X]/mL FORMALDEHYDE - 6 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 6 [hp_X]/mL HUMAN MILK - 30 [hp_X]/mL LACTIC ACID, L- - 8 [hp_X]/mL LACTOSE - 6 [hp_X]/mL MATRICARIA RECUTITA - 6 [hp_C]/mL MENADIONE - 6 [hp_X]/mL OYSTER SHELL CALCIUM CARBONATE, CRUDE - 6 [hp_C]/mL PHENYL ISOTHIOCYANATE - 6 [hp_X]/mL PIPERINE - 30 [hp_X]/mL QUERCETIN - 6 [hp_X]/mL RUTIN - 6 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR ENTERITIDIS - 6 [hp_C]/mL SKIM MILK - 6 [hp_X]/mL SUS SCROFA ILEUM - 8 [hp_X]/mL SUS SCROFA JEJUNUM - 8 [hp_X]/mL SUS SCROFA OVARY - 6 [hp_X]/mL SUS SCROFA STOMACH - 8 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 6 [hp_C]/mL TRIBASIC CALCIUM PHOSPHATE - 6 [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: | 07 May, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 12 Jun, 2023 |
| 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: | 09 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. | |
| NUI: | N0000175806 N0000175807 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0013890 N0000185508 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2ACZ6IPC6I 2P3VWU3H10 5L51B4DR1G QQ67504PXO 2PD79VF521 8SKN0B0MIM MLM29U2X85 O3B55K4YKI SQE6VB453K G39P120JQT Load more... 7THJ3EG9SY U14A832J8D A4VZ22K1WT 917J3173FT 2DI9HA706A 3T8H1794QW 5A3Y60049Z 935E97BOY8 1HG84L3525 3POA0Q644U 1XCH439UQR F9S9FFU82N J2B2A4N98G G0R4UBI2ZZ 723JX6CXY5 2E32821G6I 0D58F84LSU U71XL721QK 9IKM0I5T1E 5G06TVY3R7 Y3V16D4PV4 6A001Y4M5A C998R1XSRA TA501QD69R S7YTV04R8O T0920P9Z9A 6IO182RP7A 91D9GV0Z28 |
| 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. | |
| Pharmacologic Class MOA: | Ammonium Ion Binding Activity [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Nitrogen Binding Agent [EPC] Non-Standardized Food Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Dietary Proteins [CS] Milk Proteins [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Ammonium Ion Binding Activity [MoA] Blood Coagulation Factor [EPC] Calcium [CS] Cations Divalent [CS] Cell-mediated Immunity [PE] Dietary Proteins [CS] Increased Coagulation Factor Activity [PE] Increased Histamine Release [PE] Milk Proteins [CS] Nitrogen Binding Agent [EPC] Non-Standardized Food Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 43742-0579-1 | 30 mL in 1 BOTTLE, DROPPER (43742-0579-1) | 07 May, 2015 | 12 Jun, 2023 | 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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