| Drug NDC: | 83021-742 |
| 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: | Cetearyl Ethylhexanoate, Propylene Glycol, Glyceryl Stearate Se |
| 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: | .ALPHA.-HEXYLCINNAMALDEHYDE - .00574 g/200mL ALCOHOL - 3.5436 mL/200mL ALLANTOIN - .2 g/200mL ARCTIUM LAPPA ROOT - .003512 g/200mL BENZYL BENZOATE - .004 g/200mL BUTYLATED HYDROXYTOLUENE - .104 g/200mL C12-20 ACID PEG-8 ESTER - 4 g/200mL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE - .8 g/200mL CETEARYL ETHYLHEXANOATE - 10 g/200mL CETYL ALCOHOL - .015 g/200mL Load more... CITRAL - .01032 g/200mL COUMARIN - .003924 g/200mL FD&C YELLOW NO. 5 - .01044 g/200mL FRAGRANCE 13576 - .5 g/200mL GERANIOL - .003398 g/200mL GLYCERIN - .08784 g/200mL GLYCERYL STEARATE SE - 6 g/200mL GREEN TEA LEAF - .00679 g/200mL HYDROXYETHYL CELLULOSE, UNSPECIFIED - .12863 g/200mL IMIDUREA - .4 g/200mL ISOPROPYL ALCOHOL - .002132 g/200mL LIMONENE, (+)- - .061818 g/200mL LINALOOL, (+/-)- - .026404 g/200mL METHYLPARABEN - .6 g/200mL NIACINAMIDE - .02 g/200mL OCTINOXATE - 3.996 g/200mL OXYBENZONE - 1.6 g/200mL PANTHENOL - .04 g/200mL PHENOXYETHANOL - 1.3 g/200mL POLYOXYL 40 HYDROGENATED CASTOR OIL - 1.8 g/200mL POWDERED CELLULOSE - .001066 g/200mL PROPYLENE GLYCOL - 6.469044 g/200mL PROPYLPARABEN - .28 g/200mL RIBOFLAVIN - .00012 g/200mL TEA TREE OIL - .1 g/200mL TIOXOLONE - .3 g/200mL WATER - 155.839258 mL/200mL YEAST, UNSPECIFIED - .1 g/200mL |
| 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: | 19 Oct, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 10 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: | 8436019940600 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000185508 N0000175629 N0000184306 M0000728 N0000185370 N0000185001 M0009417 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 7X6O37OK2I 3K9958V90M 344S277G0Z 597E9BI3Z3 N863NB338G 1P9D0Z171K 9M7A3K4339 0A5MM307FC 9M64UO4C25 936JST6JCN Load more... T7EU0O9VPP A4VZ22K1WT I753WB2F1M 5EM498GW35 L837108USY PDC6A3C0OX FCZ5MH785I W2ZU1RY8B0 T4V6TWG28D M629807ATL ND2M416302 GFD7C86Q1W D81QY6I88E A2I8C7HI9T 25X51I8RD4 4Y5P7MUD51 95OOS7VE0Y WV9CM0O67Z HIE492ZZ3T 7YC686GQ8F SMD1X3XO9M 6DC9Q167V3 Z8IX2SC1OH TLM2976OFR VIF565UC2G S0FAJ1R9CD 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: | Standardized Chemical Allergen [EPC] Non-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] |
| 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] 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] 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 |
|---|---|---|---|---|
| 83021-742-01 | 200 mL in 1 TUBE (83021-742-01) | 19 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. | ||||
* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.