| Drug NDC: | 53405-0008 |
| 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: | E.o.l. |
| 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: | Stillingia Sylvatica, Zincum Gluconicum, Thiaminum Hydrochloricum, Fragaria Vesca, Nicotinamidum, Rheum (palmatum), Serotonin (hydrochloride), 5-hydroxytryptophan, Betainum Muriaticum, Biotin, Cholinum, Cysteinum, Dl-methionine, L-alanine, L-cystine, L-glutamic Acid, L-glutamine, L-lysine, L-methionine, L-serine, Para-aminobenzoic Acid, Potassium Gluconate, Thymus (suis), Thyroidinum (suis), Ubidecarenonum, Vitamin D3, Dopamine Hydrochloride, Lithium Bromatum, Squalene, Vaccinium Macrocarpon, Oxytocin, |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Inlight Creation, Llc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Spray |
| 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: | AESCULUS HIPPOCASTANUM FLOWER - 30 [hp_C]/mL ALANINE - 6 [hp_X]/mL AMINOBENZOIC ACID - 6 [hp_X]/mL BETAINE HYDROCHLORIDE - 6 [hp_X]/mL BIOTIN - 6 [hp_X]/mL BORRELIA BURGDORFERI - 12 [hp_X]/mL BROMELAINS - 6 [hp_C]/mL CANDIDA ALBICANS - 12 [hp_X]/mL CHOLECALCIFEROL - 6 [hp_X]/mL CHOLINE HYDROXIDE - 6 [hp_X]/mL Load more... COCONUT OIL - 12 [hp_X]/mL COPPER - 8 [hp_X]/mL CRANBERRY - 7 [hp_X]/mL CYSTEINE - 6 [hp_X]/mL CYSTINE - 6 [hp_X]/mL DOPAMINE HYDROCHLORIDE - 7 [hp_X]/mL FRAGARIA VESCA FRUIT - 5 [hp_X]/mL GLUTAMIC ACID - 6 [hp_X]/mL GLUTAMINE - 6 [hp_X]/mL HIPPEASTRUM PUNICEUM WHOLE - 9 [hp_C]/mL ILEX AQUIFOLIUM FLOWERING TOP - 30 [hp_C]/mL LEMON JUICE - 18 [hp_X]/mL LITHIUM BROMIDE - 7 [hp_X]/mL LYSINE - 6 [hp_X]/mL MALUS DOMESTICA FLOWER - 30 [hp_C]/mL METHIONINE - 6 [hp_X]/mL NIACINAMIDE - 5 [hp_X]/mL OXITRIPTAN - 6 [hp_X]/mL OXYTOCIN - 16 [hp_X]/mL PHENYLALANINE - 8 [hp_X]/mL POTASSIUM GLUCONATE - 6 [hp_X]/mL PUMPKIN SEED - 17 [hp_X]/mL RACEMETHIONINE - 6 [hp_X]/mL RHEUM PALMATUM ROOT - 5 [hp_X]/mL SELENIUM - 8 [hp_X]/mL SELENIUM DIOXIDE - 8 [hp_X]/mL SERINE - 6 [hp_X]/mL SEROTONIN HYDROCHLORIDE - 5 [hp_X]/mL SQUALENE - 7 [hp_X]/mL STILLINGIA SYLVATICA ROOT - 3 [hp_X]/mL SUS SCROFA THYMUS - 6 [hp_X]/mL SUS SCROFA THYROID - 6 [hp_X]/mL THIAMINE HYDROCHLORIDE - 4 [hp_X]/mL UBIDECARENONE - 6 [hp_X]/mL ZINC GLUCONATE - 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: | 06 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 13 Jun, 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: | InLight Creation, 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: | N0000175780 M0000922 M0022792 N0000175714 N0000185372 N0000175629 N0000184306 N0000185001 M0008890 M0000728 M0022797 N0000175952 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000185371 N0000185375 M0006342 M0016962 N0000185015 N0000009705 N0000175828 M0015703 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | KK0Z92II8M OF5P57N2ZX TL2TJE8QTX JK8U8K4D6K 6SO6U10H04 0J8NV9V5Q8 U182GP2CF3 4D7G21HDBC 1C6V77QF41 7THJ3EG9SY Load more... Q9L0O73W7L 789U1901C5 0MVO31Q3QS K848JZ4886 48TCX9A1VT 7L3E358N9L CG6IX3GCMU 3KX376GY7L 0RH81L854J 025JEQ4O6S 5ENR9SAN1W AGN709ANTJ 864G646I84 K3Z4F929H6 EF626V855K AE28F7PNPL 25X51I8RD4 C1LJO185Q9 1JQS135EYN 47E5O17Y3R 12H3K5QKN9 GH30P1VXK2 73JWT2K6T3 G025DAL7CE H6241UJ22B 9N3UK29E57 452VLY9402 GKN429M9VS 7QWM220FJH QBR70R4FBK 7B69B0BD62 6RV024OAUQ M572600E5P EJ27X76M46 U6WSN5SQ1Z |
| 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: | Amino Acid [EPC] Vitamin B Complex Member [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Vitamin D [EPC] Copper-containing Intrauterine Device [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Oxytocic [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] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [PE] Increased Uterine Smooth Muscle Contraction or Tone [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: | Amino Acids [CS] Vitamin B Complex [CS] Fungal Proteins [CS] Allergens [CS] Vitamin D [CS] Copper [CS] Dietary Proteins [CS] Plant Proteins [CS] Oxytocin [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] Amino Acid [EPC] Amino Acids [CS] Catecholamine [EPC] Catecholamines [CS] Cell-mediated Immunity [PE] Copper Absorption Inhibitor [EPC] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Copper Ion Absorption [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Fruit Proteins [EXT] Fungal Proteins [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Increased Large Intestinal Motility [PE] Increased Uterine Smooth Muscle Contraction or Tone [PE] Inhibit Ovum Fertilization [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Methylating Activity [MoA] Methylating Agent [EPC] Mood Stabilizer [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Oxytocic [EPC] Oxytocin [CS] Plant Proteins [CS] Potassium Compounds [CS] Potassium Salt [EPC] Vitamin B Complex Member [EPC] Vitamin B Complex [CS] Vitamin D [CS] Vitamin D [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 |
|---|---|---|---|---|
| 53405-0008-1 | 60 mL in 1 BOTTLE, SPRAY (53405-0008-1) | 06 Dec, 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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