| Drug NDC: | 83021-300 |
| 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: | Anubis Barcelona Regul Oil |
| 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: | Propylene Glycol, Glyceryl Stearate Se, Humulus Lupulus (hops) Cone Extract |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Anubis Cosmetics Sl |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Cream |
| 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: | ALCOHOL - .08 mL/200mL ARCTIUM LAPPA ROOT - .012 g/200mL C13-14 ISOPARAFFIN - .48 g/200mL CETEARYL ETHYLHEXANOATE - 4 g/200mL CETOSTEARYL ALCOHOL - 26 g/200mL ETHYLHEXYLGLYCERIN - .0028 g/200mL FD&C YELLOW NO. 5 - .00004 g/200mL FRAGRANCE 13576 - .6 g/200mL GLYCERIN - .048 g/200mL GLYCERYL STEARATE SE - 7 g/200mL Load more... HOPS - .0012 g/200mL IMIDUREA - .6 g/200mL LAURETH-7 - .12 g/200mL LIMONENE, (+)- - .08398 g/200mL METHYLCHLOROISOTHIAZOLINONE - .045 g/200mL METHYLISOTHIAZOLINONE - .15 g/200mL METHYLPARABEN - .48 g/200mL MINERAL OIL - 6 g/200mL NIACINAMIDE - .023 g/200mL PANTHENOL - .1 g/200mL PEG/PPG-20/6 DIMETHICONE - 1.372 g/200mL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) - .0012 g/200mL PHENOXYETHANOL - .0252 g/200mL POLYACRYLAMIDE (CROSSLINKED - .8 g/200mL 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) - 10.148 g/200mL PROPYLENE GLYCOL - .24 g/200mL PROPYLPARABEN - .00012 g/200mL RIBOFLAVIN - .3 g/200mL TIOXOLONE - .004 g/200mL TRIISOPROPANOLAMINE - 123.55598 mL/200mL WATER - .023 g/200mL YEAST, UNSPECIFIED - |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | TOPICAL |
| 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: | OTC MONOGRAPH FINAL |
| 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: | 20 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 14 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. | |
| Application Number: | M006 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. | |
| 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: | ANUBIS COSMETICS SL |
| 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: | 8436019941300 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417 N0000185371 N0000185375 M0006342 M0016962 M0008672 N0000185508 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 3K9958V90M 597E9BI3Z3 E4F12ROE70 9M64UO4C25 2DMT128M1S 147D247K3P I753WB2F1M 5EM498GW35 PDC6A3C0OX FCZ5MH785I Load more... 01G73H6H83 M629807ATL Z95S6G8201 GFD7C86Q1W DEL7T5QRPN 229D0E1QFA A2I8C7HI9T T5L8T28FGP 25X51I8RD4 WV9CM0O67Z PWZ7N4UIKE 255PIF62MS HIE492ZZ3T 6DC9Q167V3 Z8IX2SC1OH TLM2976OFR S0FAJ1R9CD W9EN9DLM98 059QF0KO0R 3NY3SM6B8U |
| 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 Chemical Allergen [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Standardized Chemical Allergen [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: | Allergens [CS] Glycerol [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] Cell-mediated Immunity [PE] Dietary Proteins [CS] Food Additives [CS] Fungal Proteins [CS] Glycerol [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Chemical Allergen [EPC] Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Fungal Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Plant Proteins [CS] Standardized Chemical Allergen [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 |
|---|---|---|---|---|
| 83021-300-01 | 200 mL in 1 TUBE (83021-300-01) | 20 Oct, 2022 | 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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