| Drug NDC: | 63479-1902 |
| 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: | S02 Aller-total |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | S02 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | ALLER-TOTAL |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Apis Mellifica, Berberis Vulgaris, Bos Taurus Skin, Canis Familiaris Skin, Capra Hircus Hair, Chelidonium Majus, Equus Caballus Skin, Fagus Sylvestris, Felis Catus Hair, Formicum Acidum, Histaminum, House Dust, Juniperus Communis, Lac Vaccinum, Luffa Operculata, Monosodium Glutamate, Ovis Aries Skin, Peanuts, Pollen Mix, Ribes Nigrum, Sabadilla, Sheep Hair, Solidago Virgaurea, Taraxacum Officinale, Urtica Urens, Wheat |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Apex Energetics Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Solution/ Drops |
| 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: | AMARANTHUS RETROFLEXUS POLLEN - 200 [hp_X]/mL AMBROSIA ACANTHICARPA POLLEN - 200 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA POLLEN - 200 [hp_X]/mL AMBROSIA PSILOSTACHYA POLLEN - 200 [hp_X]/mL AMBROSIA TRIFIDA POLLEN - 200 [hp_X]/mL ANTHOXANTHUM ODORATUM POLLEN - 200 [hp_X]/mL APIS MELLIFERA - 4 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 1 [hp_X]/mL BOS TAURUS SKIN - 200 [hp_X]/mL CANIS LUPUS FAMILIARIS SKIN - 200 [hp_X]/mL Load more... CAPRA HIRCUS HAIR - 200 [hp_X]/mL CHELIDONIUM MAJUS - 1 [hp_X]/mL CHENOPODIUM ALBUM POLLEN - 200 [hp_X]/mL COW MILK - 200 [hp_X]/mL CYNODON DACTYLON POLLEN - 200 [hp_X]/mL EQUUS CABALLUS SKIN - 200 [hp_X]/mL FAGUS SYLVATICA FLOWER BUD - 2 [hp_X]/mL FELIS CATUS HAIR - 200 [hp_X]/mL FORMIC ACID - 200 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 200 [hp_X]/mL HOUSE DUST - 200 [hp_X]/mL JUNIPERUS COMMUNIS STEM - 2 [hp_X]/mL LUFFA OPERCULATA FRUIT - 6 [hp_X]/mL MONOSODIUM GLUTAMATE - 90 [hp_X]/mL OVIS ARIES SKIN - 200 [hp_X]/mL PEANUT - 30 [hp_X]/mL RIBES NIGRUM FLOWER BUD - 2 [hp_X]/mL SCHOENOCAULON OFFICINALE SEED - 200 [hp_X]/mL SHEEP WOOL - 200 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 1 [hp_X]/mL SORGHUM HALEPENSE POLLEN - 200 [hp_X]/mL TARAXACUM OFFICINALE - 2 [hp_X]/mL URTICA URENS - 2 [hp_X]/mL WHEAT - 200 [hp_X]/mL XANTHIUM STRUMARIUM POLLEN - 200 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | SUBLINGUAL |
| 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: | 15 Mar, 1993 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 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. | |
| Manufacturer Name: | Apex Energetics 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: | N0000185367 N0000175629 N0000184306 M0017130 M0000728 N0000185006 N0000185001 N0000185021 M0002274 N0000185364 N0000185377 N0000185363 M0370530 N0000185371 M0006342 M0013890 N0000185003 M0576325 M0515971 N0000185374 M0006896 N0000185019 N0000185016 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 73B14PX5FW U2AI3H2J5Y K20Y81ACO3 RX18M46K8L KU1V1898XX 2KIK19R45Y 7S82P3R43Z 1TH8Q20J0U 7J12CD6O9L X2W7CLE97T Load more... 16M9MK8C4W 7E889U5RNN 098LKX5NCN 917J3173FT 175F461W10 88VZV9HGT4 6D5V13045W 1564HD0N96 0YIW783RG1 3POA0Q644U EYO007VX98 HBU87MH6OY C4MO6809HU W81N5U6R6U 947ZDF68RG QE1QX6B99R VYH9Y9BCCP 6NAF1689IO 503LYG631H 5405K23S50 577VA5B4HP 39981FM375 IHN2NQ5OF9 4J2I0SN84Y 2QOF601J1M |
| 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 EPC: | Non-Standardized Pollen Allergenic Extract [EPC] Standardized Pollen Allergenic Extract [EPC] Standardized Insect Venom Allergenic Extract [EPC] Non-Standardized Animal Skin Allergenic Extract [EPC] Non-Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [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] Increased IgG Production [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: | Pollen [CS] Allergens [CS] Bee Venoms [CS] Animal Fur [CS] Dietary Proteins [CS] Milk Proteins [CS] Dander [CS] Salivary Proteins and Peptides [CS] House Dust [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] Animal Fur [CS] Bee Venoms [CS] Cell-mediated Immunity [PE] Cells Epidermal [EXT] Dander [CS] Dietary Proteins [CS] Grain Proteins [EXT] House Dust [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Milk Proteins [CS] Non-Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized Animal Skin Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized House Dust Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Nut Proteins [EXT] Pollen [CS] Salivary Proteins and Peptides [CS] Standardized Animal Hair Allergenic Extract [EPC] Standardized Insect Venom Allergenic Extract [EPC] Standardized Pollen Allergenic Extract [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 |
|---|---|---|---|---|
| 63479-1902-1 | 30 mL in 1 BOTTLE, GLASS (63479-1902-1) | 15 Mar, 1993 | 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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