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 51 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidBOSYE BENEFITING HAIR LOTIONBejing Rimeng Biological Technology Co Ltd23c8b614-173c-4e4a-88ce-0ea808638c162025-12-27WarningsExact identifier
unii: O414PZ4LPZ
Irlvixro WART REMOVER FOR COMMON PLANTAR WARTSWART REMOVER FOR COMMON PLANTAR WARTSShenzhen Xituo Electronics Co., Ltd46d64dcc-d603-544a-e063-6394a90a176c2025-12-26WarningsExact identifier
unii: O414PZ4LPZ
Dark 30-Pack Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.46e0c74f-30d6-6c24-e063-6394a90ad4872025-12-26WarningsExact identifier
unii: ND2M416302
MG DermaSan 72ISOPROPYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.cccdefbc-09ef-417f-9b7a-1b254ae6e4382025-12-23WarningsExact identifier
unii: ND2M416302
Wart Corn Remover Fast Acting LiquidSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.469dffac-773e-8e91-e063-6394a90a77752025-12-23WarningsExact identifier
unii: O414PZ4LPZ
Quality Choice PsoriasisSALICYLIC ACIDChain Drug Marketing Association, Inc.469ffccf-f5d7-a6e0-e063-6294a90ab4532025-12-23WarningsExact identifier
unii: O414PZ4LPZ
Quality Choice TherapeuticSALICYLIC ACIDChain Drug Marketing Association, Inc.46a009be-936d-ceb0-e063-6294a90a48512025-12-23WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl Rubbing Alcohol Lil Drug Store ProductsISOPROPYL ALCOHOLLil' Drug Store Products, Incb55238e0-840a-449b-95be-4b372034c1e32025-12-23WarningsExact identifier
unii: ND2M416302
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC1e142db9-c53c-db03-e063-6394a90a9d6e2025-12-23WarningsExact identifier
unii: O414PZ4LPZ
Nizoral PsoriasisSALICYLIC ACIDKramer Laboratories6ad7f931-5411-474b-a86e-b511811b7dc02025-12-23WarningsExact identifier
unii: O414PZ4LPZ
Nizoral Psoriasis ReliefSALICYLIC ACIDKramer Laboratories3f8bc77e-a5cf-469c-9733-22d3de33ef5a2025-12-23WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Medicated Anti FungalANTIFUNGALCAVTECH HOLDING LLC46852aea-028c-71c2-e063-6394a90a80552025-12-22WarningsExact identifier
unii: O414PZ4LPZ
Precilyx Vaginal Probiotics GelCOPTIS CHINENSIS ROOT, BORIC ACID, CANARIUM ALBUM WHOLE, CALENDULA OFFICINALIS FLOWERGuangdong Quadrant Ecological Technology Co., Ltd.45a961eb-a156-0597-e063-6294a90ad45f2025-12-22WarningsExact identifier
unii: R57ZHV85D4
NTG T/Sal 3% Salicylic Acid Anti-Dandruff for Scalp Build Up ControlSALICYLIC ACIDKenvue Brands LLC3c11da1d-0b24-743a-e063-6394a90a06992025-12-22WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena T/Sal Plus 3% Salicylic Acid Anti-Dandruff for Dry, Itchy Scalp ControlSALICYLIC ACIDKenvue Brands LLC3c149239-107b-238d-e063-6294a90ac1622025-12-22WarningsExact identifier
unii: O414PZ4LPZ
Oiangna Anti FungalSELENIUM SULFIDE 1%Guangzhou Huixue Biotechnology Co., Ltd.468a7ca8-43c5-610f-e063-6294a90a07ac2025-12-22WarningsExact identifier
unii: O414PZ4LPZ
CAUDALIE Vinopure Acne SerumSALICYLIC ACIDCaudalie USA Inc.266ba6e3-5450-e9a9-e063-6394a90ab8f42025-12-22WarningsExact identifier
unii: O414PZ4LPZ
Cocokind postbiotic acne serumSALICYLIC ACID 1.5%Onekind.25d541dcee-fbed-9ffc-e053-2a95a90a43ae2025-12-22WarningsExact identifier
unii: O414PZ4LPZ
Juananan SALICYLIC ACID ESSENCESALICYLIC ACIDShanghai Zhulu Biotechnology Co., Ltd46623a3e-37bf-3ee4-e063-6294a90ae60d2025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Scholls Wellness Company LLC Clear Away Wart RemoversSALICYLIC ACIDScholls Wellness Company LLCb727c0cb-7259-4aca-e053-2a95a90a76bc2025-12-21WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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