| Drug NDC: | 66096-709 |
| 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: | Cough Relief Syrup |
| 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: | Althaea, Antimon Sulph, Antimon Tart, Bryonia, Cetraria, Chamomilla, Drosera, Echinacea Ang, Ipecac, Kali Mur, Plantago, Rumex Crisp, Senega, Spongia, Thymus, Trifolium Prat, Urtica Di, Verbascum. |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Ohm Pharma 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: | ALTHAEA OFFICINALIS ROOT - 1 [hp_X]/148mL ANTIMONY PENTASULFIDE - 12 [hp_X]/148mL ANTIMONY POTASSIUM TARTRATE - 6 [hp_X]/148mL BRYONIA ALBA ROOT - 6 [hp_X]/148mL CETRARIA ISLANDICA SUBSP. ISLANDICA - 1 [hp_X]/148mL DROSERA ROTUNDIFOLIA - 6 [hp_X]/148mL ECHINACEA ANGUSTIFOLIA - 1 [hp_X]/148mL IPECAC - 6 [hp_X]/148mL MATRICARIA RECUTITA - 1 [hp_X]/148mL PLANTAGO LANCEOLATA POLLEN - 1 [hp_X]/148mL Load more... POLYGALA SENEGA ROOT - 6 [hp_X]/148mL POTASSIUM CHLORIDE - 6 [hp_X]/148mL RUMEX CRISPUS ROOT - 6 [hp_X]/148mL SPONGIA OFFICINALIS SKELETON, ROASTED - 6 [hp_X]/148mL SUS SCROFA THYMUS - 1 [hp_X]/148mL TRIFOLIUM PRATENSE FLOWER - 1 [hp_X]/148mL URTICA DIOICA - 1 [hp_X]/148mL VERBASCUM THAPSUS - 1 [hp_X]/148mL |
| 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 Aug, 2015 |
| 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: | OHM PHARMA 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: | 0366096709259 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185367 N0000175629 N0000184306 N0000185001 M0017130 M0000728 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | TRW2FUF47H 1433F1I86N DL6OZ476V3 T7J046YI2B BJ7YPN79A1 QR44N9XPJQ VB06AV5US8 62I3C8233L G0R4UBI2ZZ DO87T1U2CI Load more... M7T6H7D4IF 660YQ98I10 9N1RM2S62C 1PIP394IID 7B69B0BD62 4JS0838828 710FLW4U46 C9TD27U172 |
| 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] |
| 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] |
| 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] Cell-mediated Immunity [PE] Increased Histamine Release [PE] Increased IgG Production [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Non-Standardized Pollen Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Pollen [CS] Potassium Compounds [CS] Potassium Salt [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 |
|---|---|---|---|---|
| 66096-709-25 | 148 mL in 1 BOTTLE (66096-709-25) | 18 Aug, 2015 | 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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