| Drug NDC: | 83021-553 |
| 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 |
| 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: | Dmae, Zirhafirm |
| 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: | .BETA.-CITRONELLOL, (R)- - .0006 g/60mL ALOE VERA LEAF - 5.988 g/60mL BAICALIN - .012 g/60mL BENZYL ALCOHOL - .456 g/60mL CETOSTEARYL ALCOHOL - 1.2 g/60mL DECYL OLEATE - 3.9 g/60mL DICAPRYLYL ETHER - 1.5 g/60mL EUGENOL - .0006 g/60mL FRAGRANCE 13576 - .114 g/60mL GLYCERIN - 3.036 g/60mL Load more... GLYCERYL MONOSTEARATE - 2.4 g/60mL HYDROXYCITRONELLAL - .0024 g/60mL JUJUBE SEED - .048 g/60mL LECITHIN, SOYBEAN - .036 g/60mL LEUZEA CARTHAMOIDES ROOT - .012 g/60mL LIMONENE, (+)- - .006 g/60mL LINALOOL, (+/-)- - .0006 g/60mL PROPANEDIOL - 2.496 g/60mL SALICYLIC ACID - .09 g/60mL SHEA BUTTER - 2.1 g/60mL SORBIC ACID - .024 g/60mL TOCOPHEROL - .0018 g/60mL WATER - 33.2616 mL/60mL XANTHAN GUM - .18 g/60mL |
| 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: | 13 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 12 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. | |
| Application Number: | M016 |
| 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, 2024 |
| 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: | 8436019954553 |
| UPC stands for Universal Product Code. | |
| NUI: | N0000181811 N0000185508 N0000175629 N0000184306 M0000728 N0000185370 N0000185001 M0009417 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | P01OUT964K ZY81Z83H0X 347Q89U4M5 LKG8494WBH 2DMT128M1S ZGR06DO97T 77JZM5516Z 3T8H1794QW 5EM498GW35 PDC6A3C0OX Load more... 230OU9XXE4 8SQ0VA4YUR I51YGQ1Q2L 1DI56QDM62 P8CUH2KYHL GFD7C86Q1W D81QY6I88E 5965N8W85T O414PZ4LPZ K49155WL9Y X045WJ989B R0ZB2556P8 059QF0KO0R TTV12P4NEE |
| 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: | Pediculicide [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] Glycerol [CS] Increased Histamine Release [PE] Increased IgG Production [PE] Non-Standardized Chemical Allergen [EPC] Pediculicide [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 |
|---|---|---|---|---|
| 83021-553-60 | 60 mL in 1 JAR (83021-553-60) | 13 Jan, 2023 | 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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