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 50 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidMEDICATED CORN REMOVERSHudson Health LLCa3eb0589-738d-4954-85c9-472c7124a0162025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Medicated Corn RemoverSALICYLIC ACIDDolgencorp, Inc. (Dollar General & Rexall)ec6d0cc7-edf2-df6e-e053-2a95a90a57862025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERPremier Brands of America Inc.38ccd276-d7b3-9604-e063-6394a90ac04b2025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSFoodhold USA3c9ce19d-e16d-47a8-90ff-46b23e51011b2025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERFSA Store Inc.3cd17f19-6e54-a618-e063-6394a90abba42025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Medicated Corn RemoversSALICYLIC ACIDFamily Dollar Services, Inc177ebc9a-6a63-31f8-e063-6394a90a8b2a2025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Body Acne TreatmentBODY SPRAYSkin PS Brands099ddba5-8e34-1e11-e063-6294a90af4c02025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHSkin PS Brandsfb230cde-b225-6df6-e053-6294a90aa6532025-12-30WarningsExact identifier
unii: O414PZ4LPZ
SA Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsffc06cbd-783d-ad07-e053-6294a90af3002025-12-30WarningsExact identifier
unii: O414PZ4LPZ
AHA/BHA SwipesRESURFACING TREATMENT PADSSKIN PS Brands02601602-badc-f18d-e063-6394a90a40062025-12-30WarningsExact identifier
unii: O414PZ4LPZ
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Salicylic AcidMEDICATED CALLUS REMOVERSFoodhold USA29e3caa0-4dc5-44d7-b7db-8bf45f6424ea2025-12-29WarningsExact identifier
unii: O414PZ4LPZ
Blemish Spot TreatmentSALICYLIC ACIDSkin Script, LLC1bf92da8-35bf-5f32-e063-6294a90a71cf2025-12-29WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CALLUS REMOVERSAmerisourceBergen Drug Corporation6aa867ee-4dd0-4308-9841-898d1ffe1edd2025-12-29WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CALLUS REMOVERSHarris Teeter, LLC0e649195-2e3b-48da-99e6-6f2c7fd686f22025-12-29WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CALLUS REMOVERSDiscount Drug Martf9ccb61c-e7cb-442c-aca9-f2ce6b4a4e432025-12-29WarningsExact identifier
unii: O414PZ4LPZ
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD4710c90b-ce88-b0b8-e063-6294a90a38602025-12-28WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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