FDA.reportPublic FDA data

ANUBISMED

Product NDC
83021-750
11-digit product format
830210750
Labeler code
83021
Product ID
83021-750_049f9ce0-73cc-2865-e063-6394a90a505a
Type
HUMAN OTC DRUG
Nonproprietary name
HA HYALURONIC
Dosage form
CREAM
Route
TOPICAL
Labeler
ANUBIS COSMETICS SL
Application
M016
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-10-17
Marketing end
2028-01-16
Substance
ALLANTOIN; ALOE VERA LEAF; FRAGRANCE 13576; GLYCERYL MONOSTEARATE; TROLAMINE; BUTYLATED HYDROXYTOLUENE; PROPYLENE GLYCOL; CETYL ALCOHOL; TROPOLONE; TOCOPHEROL; DIMETHICONE; 1,2-HEXANEDIOL; IMIDUREA; CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE; CETEARYL ETHYLHEXANOATE; MEDIUM-CHAIN TRIGLYCERIDES; CAPRYLYL GLYCOL; OCTINOXATE; GLYCERIN; GLYCERYL STEARATE SE; WATER; C12-20 ACID PEG-8 ESTER; OXYBENZONE; DECYL OLEATE
Active strength
.05; 2.5; .225; .875; .3; .0535; 1.996; .0038; .004; .0004; .25; .198; .15; .25; 1.75; 1.5; .198; 3.4965; .4975; 1.5; 27.4065; 2.25; 2; 1.9996 g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; g/50mL; 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
Pharmacologic classes
Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC], Skin Barrier Activity [PE], 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
ANUBISMED

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLANTOIN.05 g/50mL
ALOE VERA LEAF2.5 g/50mL
FRAGRANCE 13576.225 g/50mL
GLYCERYL MONOSTEARATE.875 g/50mL
TROLAMINE.3 g/50mL
BUTYLATED HYDROXYTOLUENE.0535 g/50mL
PROPYLENE GLYCOL1.996 g/50mL
CETYL ALCOHOL.0038 g/50mL
TROPOLONE.004 g/50mL
TOCOPHEROL.0004 g/50mL
DIMETHICONE.25 g/50mL
1,2-HEXANEDIOL.198 g/50mL
IMIDUREA.15 g/50mL
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE.25 g/50mL
CETEARYL ETHYLHEXANOATE1.75 g/50mL
MEDIUM-CHAIN TRIGLYCERIDES1.5 g/50mL
CAPRYLYL GLYCOL.198 g/50mL
OCTINOXATE3.4965 g/50mL
GLYCERIN.4975 g/50mL
GLYCERYL STEARATE SE1.5 g/50mL
WATER27.4065 mL/50mL
C12-20 ACID PEG-8 ESTER2.25 g/50mL
OXYBENZONE2 g/50mL
DECYL OLEATE1.9996 g/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 24 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
344S277G0ZInternal UNII lookup
ZY81Z83H0XInternal UNII lookup
5EM498GW35Internal UNII lookup
230OU9XXE4Internal UNII lookup
9O3K93S3TKInternal UNII lookup
1P9D0Z171KInternal UNII lookup
6DC9Q167V3Internal UNII lookup
936JST6JCNInternal UNII lookup
7L6DL16P1TInternal UNII lookup
R0ZB2556P8Internal UNII lookup
92RU3N3Y1OInternal UNII lookup
TR046Y3K1GInternal UNII lookup
M629807ATLInternal UNII lookup
0A5MM307FCInternal UNII lookup
9M64UO4C25Internal UNII lookup
C9H2L21V7UInternal UNII lookup
00YIU5438UInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
FCZ5MH785IInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
eac771e2-4c1b-3808-e053-2995a90ac5fcAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83021-750-50ANUBISMED50 mL in 1 JARCREAM502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83021-750ANUBISMED (HA HYALURONIC) CREAM [ANUBIS COSMETICS SL]2Current NDC, Legacy NDC, 1 package rows20230906_eac771e2-4c1b-3808-e053-2995a90ac5fc.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 64 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Itch ReliefPRAMOXINE HYDROCHLORIDE AND ZINC ACETATECVS Pharmacyc60cfbf2-6788-43dc-b23a-e3433b7f32652023-12-20WarningsExact identifier
application number: M016
Sunmark CalamineCALAMINE 8% AND ZINC OXIDE 8%Strategic Sourcing Services LLCc7467f21-56cc-43ca-abfa-e62d35c8baa62023-12-19WarningsExact identifier
application number: M016
Sunmark Witch HazelWITCH HAZELStrategic Sourcing Services LLC08c00c1a-7ec8-4624-9db0-a0e8430cd1262023-12-19WarningsExact identifier
application number: M016
Sunmark Caldyphen ClearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEStrategic Sourcing Services LLC329cd4ef-b699-46ff-a5d6-907f7c327c032023-12-19WarningsExact identifier
application number: M016
DDM CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEDiscount Drug Mart5d536077-b5c6-29b8-e053-2a91aa0a9ae12023-12-19WarningsExact identifier
application number: M016
Sunmark Phenolated CalamineCALAMINE AND ZINC OXIDE AND PHENOLStrategic Sourcing Services LLC8e68efc4-4c95-41c0-9fed-32297b1b2edc2023-12-19WarningsExact identifier
application number: M016
Calm and Heal Melting BalmALLANTOINThe Honest Company, Inc.b08a1bd6-986d-9520-e053-2995a90a865e2023-12-19WarningsExact identifier
application number: M016
TopCare CalagesicCALAMINE AND PRAMOXINE HYDROCHLORIDE LOTIONTOPCO ASSOCIATES LLC8dced3ea-147b-3d46-e053-2a95a90aa1c02023-12-18WarningsExact identifier
application number: M016
TopCare CalamineCALAMINE 8% AND ZINC OXIDE 8% LOTIONTOPCO ASSOCIATES LLC8dcf134e-0427-0c43-e053-2995a90a7c262023-12-18WarningsExact identifier
application number: M016
HEB CalaclearZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d576794-88d1-484a-e053-2991aa0aa4792023-12-18WarningsExact identifier
application number: M016
Publix Calamine MedicatedZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6ba4cf-f2cb-0ecb-e053-2991aa0a56732023-12-18WarningsExact identifier
application number: M016
TopCare CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONTOPCO ASSOCIATES LLC8dce8817-b905-4064-e053-2995a90a071e2023-12-18WarningsExact identifier
application number: M016
Assured CalamineCALAMINE 8% AND ZINC OXIDE 8%Greenbriar International9d378cc5-9af0-1389-e053-2995a90a0b962023-12-18WarningsExact identifier
application number: M016
HEB CalagesicZINC ACETATE AND PRAMOXINE HYDROCHLORIDEH E B5d579680-6bcb-1161-e053-2991aa0aead12023-12-18WarningsExact identifier
application number: M016
Publix Clear Anti-ItchZINC ACETATE AND PRAMOXINE HYDROCHLORIDEPublix5d6b905f-ed30-1ab7-e053-2a91aa0a816b2023-12-18WarningsExact identifier
application number: M016
Humco CalaclearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATEHumco Holding Group, Inc.5fca3a73-6d66-496b-bd33-6e044f9039bc2023-12-15WarningsExact identifier
application number: M016
Calamine Phenolated Topical SuspensionCALAMINE AND ZINC OXIDE AND PHENOLHumco Holding Group, Inca3816729-be2b-4b4f-a609-953576cd2e3b2023-12-15WarningsExact identifier
application number: M016
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
application number: M016
Humco Witch HazelWITCH HAZELHumco Holding Group, Inc.3cf07016-a129-49ca-8fad-b67dda5aa0092023-12-15WarningsExact identifier
application number: M016
Rite Aid CalamineCALAMINE 8% AND ZINC OXIDE 8%Rite Aid Corporation5df71189-9b36-9dee-e053-2a91aa0a9e492023-12-15WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83021-750-508302107505050 mL in 1 JAR (83021-750-50) 50 ml2022-10-172028-01-16NoNoCurrent