| Drug NDC: | 73282-0003 |
| 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: | Colic Calm Plus |
| 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: | Aloe, Asafoetida, Carbo Vegetabilis, Carum Carvi, Chamomilla, Cinchona Officinalis, Foeniculum Vulgare, Magnesia Phosphorica, Melissa Officinalis, Mentha Piperita, Prunus Spinosa, Zingiber Officinale |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Ketomi Llc |
| 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: | ACTIVATED CHARCOAL - 1 [hp_X]/mL ALOE - 8 [hp_X]/mL CARAWAY OIL - 3 [hp_X]/mL CHAMOMILE - 3 [hp_X]/mL CINCHONA OFFICINALIS BARK - 3 [hp_X]/mL FENNEL SEED - 3 [hp_X]/mL FERULA ASSA-FOETIDA RESIN - 3 [hp_X]/mL GINGER - 3 [hp_X]/mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE - 8 [hp_X]/mL MELISSA OFFICINALIS - 3 [hp_X]/mL Load more... MENTHA PIPERITA - 3 [hp_X]/mL PRUNUS SPINOSA FLOWER BUD - 3 [hp_X]/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: | 30 Aug, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 04 Nov, 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: | 06 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | Ketomi LLC |
| 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: | N0000185375 N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0016962 M0008672 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 2P3VWU3H10 V5VD430YW9 C2J9B08Q3I FGL3685T2X S003A158SB G3QC02NIE6 W9FZA51AS1 C5529G5JPQ HF539G9L3Q YF70189L0N Load more... 79M2M2UDA9 53Y84VPS2W |
| 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 Plant Allergenic Extract [EPC] Non-Standardized Food 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] |
| 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] Plant Proteins [CS] Food Additives [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] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Increased Histamine Release [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Inhibition Small Intestine Fluid/Electrolyte Absorption [PE] Magnesium Ion Exchange Activity [MoA] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Plant Proteins [CS] Stimulation Large Intestine Fluid/Electrolyte Secretion [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 |
|---|---|---|---|---|
| 73282-0003-1 | 59 mL in 1 BOTTLE, WITH APPLICATOR (73282-0003-1) | 30 Aug, 2019 | 04 Nov, 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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