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 73 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blemish Correcting SerumSALICYLIC ACIDTopiderm, Inc.84029bb8-a840-4b68-9a07-6838867332292025-06-17WarningsExact identifier
unii: O414PZ4LPZ
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC1fdff866-f534-4c16-b755-b2efd1e6e8372025-06-17WarningsExact identifier
unii: ND2M416302
Brickell Mens Products Relieving Anti-DandruffSALICYLIC ACIDBRICKELL BRANDS LLC7ba3b13b-cb78-4df8-8719-c88e556643b42025-06-16WarningsExact identifier
unii: O414PZ4LPZ
whiteningWHITENING SOAPGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad0c11-bb94-dd70-e063-6394a90a705d2025-06-16WarningsExact identifier
unii: O414PZ4LPZ
ACNE TREATMENT COTTON PADSACNE TREATMENT COTTON PADSGuangzhou Yapeng Refinement Chemical Co., Ltd.37ad7cd7-92df-82d9-e063-6294a90a0f042025-06-16WarningsExact identifier
unii: O414PZ4LPZ
WISH RUBBING ALCOHOL 99% WINTERGREENISOPROPYL ALCOHOLLJ Pharmade7b2253-7f36-4a27-8838-442ec635f69b2025-06-16WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70% WINTERGREENISOPROPYL ALCOHOLLJ Pharma98ebf7a7-7c13-4feb-90b5-21cc6dab99f62025-06-16WarningsExact identifier
unii: ND2M416302
Wart Remover PatchWART REMOVER PATCHShenzhen Earth Surface Trading Co., Ltd.37bcc410-baa4-1735-e063-6394a90acf8d2025-06-16WarningsExact identifier
unii: O414PZ4LPZ
Lunavia Salicylic Acid Foot CreamSALICYLIC ACID 12%XF Agencija Limited3c44de4b-caca-4aa7-951c-17edd4dd66682025-06-16WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidSALICYLIC ACID 12%SANSAR, LLCec6f14a4-ba91-4202-b8b9-2edf2cebe7482025-06-16WarningsExact identifier
unii: O414PZ4LPZ
HAND-I-SAN75% ISOPROPYL ALCOHOL HAND SANITIZERZECO, LLC37627a51-cf31-013c-e063-6294a90ae13a2025-06-13WarningsExact identifier
unii: ND2M416302
VENROCKPIROCTONE OLAMINE AND SALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.372feca7-f6f1-cd38-e063-6294a90a3bfe2025-06-12WarningsExact identifier
unii: O414PZ4LPZ
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION75e15ed6-e871-4dde-b7fc-145054626fa92025-06-12WarningsExact identifier
unii: O414PZ4LPZ
La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc2ac3a8c0-e0ed-435f-90fb-72c7a55a06732025-06-12WarningsExact identifier
unii: O414PZ4LPZ
BURRRER Wart RemoverWART REMOVERShenzhen TeLaFaErJiaLuo Technology Co., Ltd.374735f6-426d-8fe5-e063-6394a90ab2b82025-06-11WarningsExact identifier
unii: O414PZ4LPZ
Facial Cleansing WipesFACIAL CLEANSING WIPESShenzhen Shierjie Biological Engineering Co., LTD36f7677a-ec73-e677-e063-6294a90ad4802025-06-07WarningsExact identifier
unii: O414PZ4LPZ
Singular Wipes fragrance freeISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC6026cb8b-4556-41bd-a7b9-d9bb309005c72025-06-06WarningsExact identifier
unii: ND2M416302
Travel WipesISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLC818b4280-a1cb-4c69-908f-f687f7c84ad92025-06-06WarningsExact identifier
unii: ND2M416302
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incb36837e3-ea1c-41db-b52c-4175100895292025-06-05WarningsExact identifier
unii: O414PZ4LPZ
VENROCKSALICYLIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.349ae621-c832-128c-e063-6294a90a284d2025-06-05WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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