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 67 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EltaMD Laser Balm	PETROLATUM SKIN PROTECTANT	CP Skin Health Group, Inc	1c67ce72-89d9-4c4f-a9b0-28b7e67d30eb	2023-11-09	Warnings	Exact identifier application number: M016
DiaperDerm Diaper Rash	ZINC OXIDE	Diaperderm Inc	4e1fce3e-c2b7-42da-9953-1dbb13e2467c	2023-11-06	Warnings	Exact identifier application number: M016
Doctors Diaper Rash Cream	ZINC OXIDE	DOCTOR'S DIAPER RASH CREAM, INC	0988ccb1-7881-4d97-bcbf-d0cf4316e4be	2023-11-06	Warnings	Exact identifier application number: M016
DERMOIA Manuka Honey Eczema Cream	OATMEAL	TREASUREWISE LLC	a48e52a3-b681-4489-a1fd-6b09d8bc9c55	2023-11-06	Warnings	Exact identifier application number: M016
GL HEALTH Barrier Skin Protectant	ZINC OXIDE	GL HEALTH, INC.	76cfa330-fea9-48d4-b187-469154765d39	2023-11-06	Warnings	Exact identifier application number: M016
Skin-lube	PETROLATUM, DIMETHICONE	The Hygenic Company, LLC.	d1005dec-04f6-3f88-e053-2a95a90ad9cb	2023-11-05	Warnings	Exact identifier application number: M016
Dr. Sheffield Anti Itch Cream	ANTI ITCH CREAM	Sheffield Pharmaceuticals LLC	77f0593e-f694-4c02-9fd9-ad56ff2a920c	2023-10-30	Warnings	Exact identifier application number: M016
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016 ndc (product): 83021-877
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	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