Anubis Barcelona

Product NDC: 83021-877
11-digit product format: 830210877
Labeler code: 83021
Product ID: 83021-877_04522475-b44b-eb2f-e063-6294a90afc2b
Type: HUMAN OTC DRUG
Nonproprietary name: Glycerin, Sorbitol, Aloe Barbadensis Leaf Juice
Dosage form: CONCENTRATE
Route: TOPICAL
Labeler: ANUBIS COSMETICS SL
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2022-10-19
Marketing end: 2027-01-14
Substance: SORBITOL; SACCHAROMYCES LYSATE; WATER; 1,2-HEXANEDIOL; GLYCERIN; LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE; HYALURONATE SODIUM; FD&C BLUE NO. 1; PHENOXYETHANOL; ALOE VERA LEAF; ETHYLHEXYLGLYCERIN
Active strength: .0525; .00075; 1.219341; .0165; .16875; .000015; .0075; .000009; .0141; .008955; .0015 g/1.5mL; g/1.5mL; mL/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL; g/1.5mL
Pharmacologic classes: Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-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
SORBITOL	.0525 g/1.5mL
SACCHAROMYCES LYSATE	.00075 g/1.5mL
WATER	1.219341 mL/1.5mL
1,2-HEXANEDIOL	.0165 g/1.5mL
GLYCERIN	.16875 g/1.5mL
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE	.000015 g/1.5mL
HYALURONATE SODIUM	.0075 g/1.5mL
FD&C BLUE NO. 1	.000009 g/1.5mL
PHENOXYETHANOL	.0141 g/1.5mL
ALOE VERA LEAF	.008955 g/1.5mL
ETHYLHEXYLGLYCERIN	.0015 g/1.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 11 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
506T60A25R	Internal UNII lookup
R85W246Z1C	Internal UNII lookup
059QF0KO0R	Internal UNII lookup
TR046Y3K1G	Internal UNII lookup
PDC6A3C0OX	Internal UNII lookup
D2QHA03458	Internal UNII lookup
YSE9PPT4TH	Internal UNII lookup
H3R47K3TBD	Internal UNII lookup
HIE492ZZ3T	Internal UNII lookup
ZY81Z83H0X	Internal UNII lookup
147D247K3P	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
eb651769-4d98-2b3b-e053-2a95a90a36b0	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83021-877-07	Anubis Barcelona	1.5 mL in 1 VIAL, SINGLE-USE	CONCENTRATE	1.5		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83021-877	ANUBIS BARCELONA (GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE) CONCENTRATE [ANUBIS COSMETICS SL]	2	Current NDC, 1 package rows	20230902_eb651769-4d98-2b3b-e053-2a95a90a36b0.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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydro Gel	GLYCERIN 20%	Trifecta Pharmaceuticals USA LLC	02e8e5d0-7844-39fe-e063-6394a90a57e1	2024-01-19	Warnings	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Sled Distribution, LLC	e73a4b7a-7b27-abfc-e053-2995a90a35c2	2024-01-15	Warnings	Exact identifier application number: M016
Sunmark Caldiphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	2024-01-12	Warnings	Exact identifier application number: M016
EIGHT HOUR NIGHT	DIMETHICONE	REVLON	b3b277f9-565a-636c-e053-2995a90a94d2	2024-01-12	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Creamy	OATMEAL	L'Oreal USA Products Inc	bcf7b985-6875-4033-a412-1bb6d3afa6d8	2024-01-01	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing	PETROLATUM	L'Oreal USA Products Inc.	1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95	2023-12-31	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Baby Healing	PETROLATUM	L'Oreal USA Products Inc.	fe665bbc-1172-4f59-acc6-8d5c179693b6	2023-12-31	Warnings	Exact identifier application number: M016
Quality Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Market Association	e3c0c46d-3d85-411d-a543-009064cdd19e	2023-12-28	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Therapeutic Hand	DIMETHICONE	L'Oreal USA Products Inc	7fe49112-4180-415c-a380-768a8d6b2185	2023-12-28	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
506T60A25R	SORBITOL	50-70-4	SORBITOL
R85W246Z1C	SACCHAROMYCES LYSATE		SACCHAROMYCES LYSATE
059QF0KO0R	WATER	7732-18-5	WATER
TR046Y3K1G	1,2-HEXANEDIOL	6920-22-5	1,2-HEXANEDIOL
PDC6A3C0OX	GLYCERIN	56-81-5	GLYCERIN
D2QHA03458	LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE		LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
YSE9PPT4TH	HYALURONATE SODIUM	9067-32-7	HYALURONATE SODIUM
H3R47K3TBD	FD&C BLUE NO. 1	3844-45-9	FD&C BLUE NO. 1
HIE492ZZ3T	PHENOXYETHANOL	122-99-6	PHENOXYETHANOL
ZY81Z83H0X	ALOE VERA LEAF	8001-97-6	ALOE VERA LEAF
147D247K3P	ETHYLHEXYLGLYCERIN	70445-33-9	ETHYLHEXYLGLYCERIN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
83021-877-07	83021087707	1.5 mL in 1 VIAL, SINGLE-USE (83021-877-07)	1.5 ml	2023-02-21	2027-01-14	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anubis Barcelona - ANUBIS COSMETICS SL \| GDC OF FLORIDA IMPORTS, INC.	ANUBIS COSMETICS SL \| GDC OF FLORIDA IMPORTS, INC.	2023-09-01	HUMAN OTC DRUG LABEL	2