FDA.reportPublic FDA data

NDC 46521-003 - Bio-Groom Ear-Care

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
46521-003
Package NDCs from labels
46521-003-04, 46521-003-08, 46521-003-01, 46521-003-28
Manufacturer
Bio-Derm Laboratories Inc.
Effective date
2011-06-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BIO-GROOM ® EAR-CARE™ NON OILY-NON STICKY EAR CLEANERBio-Derm Laboratories Inc.2011-06-10OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46521-003-01Bio-Groom Ear-Care29 mL in 1 BOTTLESOLUTION291
46521-003-04Bio-Groom Ear-Care118 mL in 1 BOTTLESOLUTION1181
46521-003-08Bio-Groom Ear-Care236 mL in 1 BOTTLESOLUTION2361
46521-003-28Bio-Groom Ear-Care3800 mL in 1 BOTTLESOLUTION38001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46521-003BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]14 package rows20110803_39e164d2-84f2-4bfc-be0d-3876a6e5c66a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BORIC ACIDACTIVE INGREDIENTR57ZHV85D4BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
BORIC ACIDACTIVE MOIETYR57ZHV85D4BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]1

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 75 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DermaD Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.e52c647b-8cdc-4023-af22-fbfb84ea0ada2025-05-27WarningsExact identifier
unii: O414PZ4LPZ
DermaER Psoriasis TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.f62e6c5e-6e80-4b75-a0b1-c893224d9ce42025-05-27WarningsExact identifier
unii: O414PZ4LPZ
VLITEPRO First Aid WipesISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co., Ltd.35a7873a-e340-aae3-e063-6294a90a767f2025-05-26WarningsExact identifier
unii: ND2M416302
Aveeno Positively Radiant Clear Complexion Foaming CleanserSALICYLIC ACIDKenvue Brands LLCec136786-9d46-a022-e053-2a95a90a07522025-05-26WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Stubborn Body Acne Cleanser and ExfoliatorSALICYLIC ACIDKenvue Brands LLCdd13b492-5c82-a7d0-e053-2a95a90a62b32025-05-26WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Stubborn Texture Daily CleanserSALICYLIC ACIDKenvue Brands LLCef2d9cd5-5c6c-4839-af5d-6bc21187b1322025-05-26WarningsExact identifier
unii: O414PZ4LPZ
NAELI Exfoliator AHA-BHA Face CleanserSALICYLIC ACIDALLI LLC16bf50c6-4a9d-4242-94a2-d2165b82e7ce2025-05-22WarningsExact identifier
unii: O414PZ4LPZ
First Aid Beauty Acne Clearing PadsSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35bd600b-5da6-5225-e063-6294a90ac6f32025-05-22WarningsExact identifier
unii: O414PZ4LPZ
First Aid Beauty Body Acne Clearing MistSALICYLIC ACIDThe Procter & Gamble Manufacturing Company35be1450-01c1-1668-e063-6394a90af9b52025-05-22WarningsExact identifier
unii: O414PZ4LPZ
Tagrid ANTI FUNGALZINC PYRITHIONE,SALICYLIC ACIDTAGRID LLC3376b104-1f07-fab3-e063-6394a90a0ca42025-05-22WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl AlcoholISOPROPYL ALCOHOLSafeway, Inc.29e5c152-15d7-4080-abf0-f76f8e9cbf5a2025-05-16WarningsExact identifier
unii: ND2M416302
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC353ed0a4-dcae-7748-e063-6294a90ac3f72025-05-16WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl Alcohol WintergreenISOPROPYL ALCOHOLSafeway, Inc.14a22d1e-e498-4661-ab30-6696b8b914d72025-05-16WarningsExact identifier
unii: ND2M416302
Dickinsons Original Witch Hazel Exfoliating Bubble TonerSALICYLIC ACIDDickinson Brands Inc.5a5119a2-d6ca-4932-9df6-faed97e1d2a12025-05-16WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcoholISOPROPYL ALCOHOLSafeway, Inc.69295fa8-0f0f-495c-a2ef-1414c6fa93a42025-05-16WarningsExact identifier
unii: ND2M416302
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Compound W Corn RemoverSALICYLIC ACIDMedtech Products Inc.a13037aa-13f3-4ffd-a5ae-f0962013b0f72025-05-13WarningsExact identifier
unii: O414PZ4LPZ
uikeaft Wart and Corn RemoverWART AND CORN REMOVERGuangzhou Zanming Trading Co., Ltd.34c3a430-acb9-8e08-e063-6294a90a84c32025-05-10WarningsExact identifier
unii: O414PZ4LPZ
Salicylic Acid 40% / Corn RemoverSALICYLIC ACIDASO Pharmaceutical Co.,ltd.34b68520-f1ac-b402-e063-6394a90aed402025-05-09WarningsExact identifier
unii: O414PZ4LPZ
Maokang Alcohol Prep Pad Saturated with 70% Isopropyl AlcoholISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltda13a971c-769a-4909-8980-9e8bec4a03612025-05-09WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.