Home NDC 83021-617 Anubis Barcelona
Product NDC 83021-617
11-digit product format 830210617
Labeler code 83021
Product ID 83021-617_045252bb-c4b5-54e9-e063-6394a90aba06
Type HUMAN OTC DRUG
Nonproprietary name Peg-40 Hydrogenated Castor Oil, Propylene Glycol, Allantoin
Dosage form CONCENTRATE
Route TOPICAL
Labeler ANUBIS COSMETICS SL
Application M006
Marketing category OTC MONOGRAPH FINAL
Marketing start 2022-10-21
Marketing end 2027-09-20
Substance PROPYLPARABEN; ALLANTOIN; PANTHENOL; FD&C YELLOW NO. 5; PROPYLENE GLYCOL; ARCTIUM LAPPA ROOT; METHYLPARABEN; TIOXOLONE; WATER; ALCOHOL; POLYOXYL 40 HYDROGENATED CASTOR OIL; YEAST, UNSPECIFIED; ASCORBYL PALMITATE; RIBOFLAVIN; ETHYLPARABEN; TOCOPHEROL; CITRAL; LIMONENE, (+)-; POWDERED CELLULOSE; ISOPROPYL ALCOHOL; HYDROXYETHYL CELLULOSE, UNSPECIFIED; LEVOMENOL; FARNESOL; FRAGRANCE 13576; PHENOXYETHANOL; BUTYLPARABEN; NIACINAMIDE
Active strength .0000001; .0125; .0025; .00001; .0069; .000035; .00500065; .01; 3.12515585; 1.756; .02; .01725; .00005; .000003; .00000015; .000001; .000097; .002095; .0003; .0006; .017; .0045; .0005; .01; .000003; .00000025; .0001 g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; mL/5mL; mL/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL; g/5mL
Pharmacologic classes Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC]
NDC exclude flag No
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Anubis Barcelona Active Ingredients# Ingredient, Strength table Ingredient Strength PROPYLPARABEN .0000001 g/5mL ALLANTOIN .0125 g/5mL PANTHENOL .0025 g/5mL FD&C YELLOW NO. 5 .00001 g/5mL PROPYLENE GLYCOL .0069 g/5mL ARCTIUM LAPPA ROOT .000035 g/5mL METHYLPARABEN .00500065 g/5mL TIOXOLONE .01 g/5mL WATER 3.12515585 mL/5mL ALCOHOL 1.756 mL/5mL POLYOXYL 40 HYDROGENATED CASTOR OIL .02 g/5mL YEAST, UNSPECIFIED .01725 g/5mL ASCORBYL PALMITATE .00005 g/5mL RIBOFLAVIN .000003 g/5mL ETHYLPARABEN .00000015 g/5mL TOCOPHEROL .000001 g/5mL CITRAL .000097 g/5mL LIMONENE, (+)- .002095 g/5mL POWDERED CELLULOSE .0003 g/5mL ISOPROPYL ALCOHOL .0006 g/5mL HYDROXYETHYL CELLULOSE, UNSPECIFIED .017 g/5mL LEVOMENOL .0045 g/5mL FARNESOL .0005 g/5mL FRAGRANCE 13576 .01 g/5mL PHENOXYETHANOL .000003 g/5mL BUTYLPARABEN .00000025 g/5mL NIACINAMIDE .0001 g/5mL
Harmonized UNII identifiers# UNII identifiers page 1 of 2 · 27 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83021-617-05 Anubis Barcelona 5 mL in 1 VIAL, GLASS CONCENTRATE 5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83021-617 ANUBIS BARCELONA (PEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOIN) CONCENTRATE [ANUBIS COSMETICS SL] 2 Current NDC, Legacy NDC, 1 package rows 20230902_eb9244ea-6102-3cbe-e053-2a95a90ab8f6.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 55 of 55 · 1,088 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Replenix Acne Gly-Sal 2-2 Foaming Cleanser SALICYLIC ACID Topiderm, Inc. 811dbf95-2b39-45c5-99a2-33c3c9d19570 2019-12-19 Warnings Exact identifier application number: M006 REPLENIX ACNE SOLUTIONS WASH BENZOYL PEROXIDE Topiderm, Inc. 8dc2d27d-3cc4-4874-b4c2-32607849b205 2019-12-17 Warnings Exact identifier application number: M006 REPLENIX ACNE Solution BENZOYL PEROXIDE WASH BENZOYL PEROXIDE Topiderm, Inc. 235e9dd5-13f2-4078-9807-1d87fd9e6cba 2019-12-17 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc 03d4c298-8f44-41f7-b086-96ae836152bb 2019-10-31 Warnings Exact identifier application number: M006 Replenix Acne BENZOYL PEROXIDE Topiderm, Inc. c12f9005-a549-4447-9beb-df7126f77df1 2019-10-31 Warnings Exact identifier application number: M006 Gly-Sal 10-2 Pads SALICYLIC ACID Topiderm, Inc. b39e845d-4c40-4f9e-9cb5-a8386f326652 2019-10-23 Warnings Exact identifier application number: M006 Gly-Sal 5-2 Pads SALICYLIC ACID Topiderm, Inc. e73bd26c-cdc2-47ab-94e8-3bc49a9b19e8 2019-10-22 Warnings Exact identifier application number: M006 SKIN MEDICA Purifying Foaming Wash SALICYLIC ACID Allergan, Inc. 064d9e2b-077f-4229-b653-666fc5479ae2 2013-03-01 Warnings Exact identifier application number: M006
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83021-617-05 83021061705 5 mL in 1 VIAL, GLASS (83021-617-05) 5 ml 2022-10-21 2027-09-20 No No Current