FDA.reportPublic FDA data

Anubis Barcelona Spa Line

Product NDC
83021-305
11-digit product format
830210305
Labeler code
83021
Product ID
83021-305_04529ef6-e35a-95c2-e063-6394a90ae70d
Type
HUMAN OTC DRUG
Nonproprietary name
ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-14
Marketing end
2027-10-13
Substance
FRAGRANCE 13576; GRAPE SEED OIL; GLYCERYL MONOSTEARATE; LINALOOL, (+/-)-; PHENOXYETHANOL; PROPYLENE GLYCOL; TITANIUM DIOXIDE; PALMITIC ACID; BUTYLATED HYDROXYTOLUENE; STARCH, RICE; ALCOHOL; C12-20 ACID PEG-8 ESTER; TROLAMINE; ISOMETHYL-.ALPHA.-IONONE; HYDROXYACETOPHENONE; PERLITE; GLYCERIN; ETHYLHEXYLGLYCERIN; .BETA.-CITRONELLOL, (R)-; WATER; STEARIC ACID; CETEARYL ETHYLHEXANOATE
Active strength
.15; .25; 3.5; .0114; .45; 1.5; .25; 1; .25; 5.5; 4.752; 1; .25; .00639; .25; 4; .0115; .05; .012; 25.04945; 1; .75 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; mL/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL
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 Spa Line

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FRAGRANCE 13576.15 g/50mL
GRAPE SEED OIL.25 g/50mL
GLYCERYL MONOSTEARATE3.5 g/50mL
LINALOOL, (+/-)-.0114 g/50mL
PHENOXYETHANOL.45 g/50mL
PROPYLENE GLYCOL1.5 g/50mL
TITANIUM DIOXIDE.25 g/50mL
PALMITIC ACID1 g/50mL
BUTYLATED HYDROXYTOLUENE.25 g/50mL
STARCH, RICE5.5 g/50mL
ALCOHOL4.752 mL/50mL
C12-20 ACID PEG-8 ESTER1 g/50mL
TROLAMINE.25 g/50mL
ISOMETHYL-.ALPHA.-IONONE.00639 g/50mL
HYDROXYACETOPHENONE.25 g/50mL
PERLITE4 g/50mL
GLYCERIN.0115 g/50mL
ETHYLHEXYLGLYCERIN.05 g/50mL
.BETA.-CITRONELLOL, (R)-.012 g/50mL
WATER25.04945 g/50mL
STEARIC ACID1 g/50mL
CETEARYL ETHYLHEXANOATE.75 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5EM498GW35Internal UNII lookup
930MLC8XGGInternal UNII lookup
230OU9XXE4Internal UNII lookup
D81QY6I88EInternal UNII lookup
HIE492ZZ3TInternal UNII lookup
6DC9Q167V3Internal UNII lookup
15FIX9V2JPInternal UNII lookup
2V16EO95H1Internal UNII lookup
1P9D0Z171KInternal UNII lookup
4DGK8B7I3SInternal UNII lookup
3K9958V90MInternal UNII lookup
9M7A3K4339Internal UNII lookup
9O3K93S3TKInternal UNII lookup
9XP4LC555BInternal UNII lookup
G1L3HT4CMHInternal UNII lookup
0SG101ZGK9Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
147D247K3PInternal UNII lookup
P01OUT964KInternal UNII lookup
059QF0KO0RInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eb01a962-ab38-18ec-e053-2995a90acdebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-305-50Anubis Barcelona Spa Line50 mL in 1 TUBECREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-305ANUBIS BARCELONA SPA LINE (ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230902_eb01a962-ab38-18ec-e053-2995a90acdeb.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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-305-508302103055050 mL in 1 TUBE (83021-305-50) 50 ml2022-10-142027-10-13NoNoCurrent