| Drug NDC: | 63479-1912 |
| 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: | S12 Airborne |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | S12 |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | AIRBORNE |
| 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: | Alfalfa, Allium Sativum, Arsenicum Iodatum, Barley, Betula Pubescens, Brown Rice, Corn Grain, Euphrasia Officinalis, Feather Mix, Hair Mix, Histaminum, House Dust Mite, Lolium Perenne, Oat, Perfoliate Honeysuckle, Phleum Pratense, Pollen Mix, Rye, Sabadilla, Silicea, Skin Mix, Solidago Virgaurea, Taraxacum Officinale, Terebinthina, 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: | AGROSTIS GIGANTEA POLLEN - 30 [hp_C]/mL ALFALFA TOP - 30 [hp_C]/mL AMARANTHUS PALMERI POLLEN - 30 [hp_C]/mL AMARANTHUS RETROFLEXUS POLLEN - 30 [hp_C]/mL AMBROSIA ARTEMISIIFOLIA POLLEN - 30 [hp_C]/mL AMBROSIA TRIFIDA POLLEN - 30 [hp_C]/mL ANAS PLATYRHYNCHOS FEATHER - 30 [hp_C]/mL ANSER ANSER FEATHER - 30 [hp_C]/mL ANTHOXANTHUM ODORATUM POLLEN - 30 [hp_C]/mL ARSENIC TRIIODIDE - 30 [hp_C]/mL Load more... ARTEMISIA VULGARIS POLLEN - 30 [hp_C]/mL BARLEY - 30 [hp_C]/mL BETULA LENTA POLLEN - 30 [hp_C]/mL BETULA OCCIDENTALIS POLLEN - 30 [hp_C]/mL BETULA PUBESCENS FLOWER BUD - 30 [hp_C]/mL BOS TAURUS SKIN - 30 [hp_C]/mL BROWN RICE - 30 [hp_C]/mL CANIS LUPUS FAMILIARIS SKIN - 30 [hp_C]/mL CAPRA HIRCUS HAIR - 30 [hp_C]/mL CAPRA HIRCUS SKIN - 30 [hp_C]/mL CHENOPODIUM ALBUM POLLEN - 30 [hp_C]/mL CORN GRAIN - 30 [hp_C]/mL DACTYLIS GLOMERATA POLLEN - 30 [hp_C]/mL DERMATOPHAGOIDES FARINAE - 30 [hp_C]/mL DERMATOPHAGOIDES PTERONYSSINUS - 30 [hp_C]/mL DYSPHANIA AMBROSIOIDES POLLEN - 30 [hp_C]/mL EQUUS CABALLUS SKIN - 30 [hp_C]/mL EUPHRASIA STRICTA - 30 [hp_C]/mL FELIS CATUS HAIR - 30 [hp_C]/mL FESTUCA PRATENSIS POLLEN - 30 [hp_C]/mL GALLUS GALLUS FEATHER - 30 [hp_C]/mL GARLIC - 30 [hp_C]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_C]/mL IVA ANNUA POLLEN - 30 [hp_C]/mL LEUCANTHEMUM VULGARE POLLEN - 30 [hp_C]/mL LOLIUM PERENNE POLLEN - 30 [hp_C]/mL LOLIUM PERENNE TOP - 30 [hp_C]/mL LONICERA CAPRIFOLIUM FLOWER - 30 [hp_C]/mL OAT - 30 [hp_C]/mL PHLEUM PRATENSE POLLEN - 30 [hp_C]/mL PHLEUM PRATENSE TOP - 30 [hp_C]/mL POA PRATENSIS POLLEN - 30 [hp_C]/mL RYE - 30 [hp_C]/mL SCHOENOCAULON OFFICINALE SEED - 30 [hp_C]/mL SHEEP WOOL - 30 [hp_C]/mL SILICON DIOXIDE - 30 [hp_C]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 30 [hp_C]/mL TARAXACUM OFFICINALE - 30 [hp_C]/mL TARAXACUM OFFICINALE POLLEN - 30 [hp_C]/mL TURPENTINE OIL - 30 [hp_C]/mL WHEAT - 30 [hp_C]/mL XANTHIUM STRUMARIUM POLLEN - 30 [hp_C]/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: | 13 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. | |
| UPC: | 0818960012083 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185006 N0000185367 N0000175629 N0000184306 N0000185001 M0017130 M0000728 N0000185373 M0008280 N0000185371 M0006342 N0000185016 N0000185364 N0000185377 N0000185363 M0370530 N0000185375 M0016962 N0000185005 M0419493 M0028968 N0000185003 M0576325 M0515971 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | HU8V6E7HOA SQI2NBY9KR 1GH3WV23KH 73B14PX5FW K20Y81ACO3 KU1V1898XX 83B65P4796 15XI414745 2KIK19R45Y 3029988O2T Load more... ANT994T71D 5PWM7YLI7R JQ5HI5004M R889N2L976 32JS91VU1G 7J12CD6O9L 659G217HPG X2W7CLE97T 16M9MK8C4W JLG9853E2P 098LKX5NCN C1Z9U7094Z 83N78IDA7P PR9U2YPF3Q 57L1Z5378K WIB701MW2H 88VZV9HGT4 C9642I91WL 1564HD0N96 A0WFQ8P6N1 1FCM16V0FV V1V998DC17 3POA0Q644U Y2U5S5PF22 H9E0IX4MOX 4T81LB52R0 9ZUC5NG0RD 5N1WD9784U Z6J799EAJK 65M88RW2EG S7PW24BX20 SCB8J7LS3T 0R4AQI398X 6NAF1689IO 503LYG631H ETJ7Z6XBU4 5405K23S50 39981FM375 WQ3S5294XY C5H0QJ6V7F 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: | Standardized Pollen Allergenic Extract [EPC] Non-Standardized Pollen Allergenic Extract [EPC] Non-Standardized Feather Allergenic Extract [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Animal Skin Allergenic Extract [EPC] Non-Standardized Animal Hair Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Standardized Insect Allergenic Extract [EPC] Standardized Animal Hair 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] Feathers [CS] Dietary Proteins [CS] Animal Fur [CS] Plant Proteins [CS] Antigens, Dermatophagoides [CS] Insect Proteins [CS] Dander [CS] Salivary Proteins and Peptides [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] Antigens Dermatophagoides [CS] Cell-mediated Immunity [PE] Cells Epidermal [EXT] Dander [CS] Dietary Proteins [CS] Feathers [CS] Grain Proteins [EXT] Increased Histamine Release [PE] Increased IgG Production [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 63479-1912-1 | 60 mL in 1 BOTTLE, GLASS (63479-1912-1) | 06 Apr, 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. | ||||
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