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 27 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JTOPYRTSALICYLIC ACID PADGuangzhou Yixiang Trading Co., Ltd.3dfb8f94-f734-de7d-e063-6394a90abed82026-03-25WarningsExact identifier
unii: O414PZ4LPZ
Oxy 3-IN-1 Acne Cleansing PadsSALICYLIC ACIDThe Mentholatum Company4dcc9f0a-24d0-d62e-e063-6394a90aafe22026-03-24WarningsExact identifier
unii: O414PZ4LPZ
Plantar Wart RemoverSALICYLIC ACIDCVS Pharmacy2afaf3e0-d321-48f9-8ffa-4892dde3b6a92026-03-24WarningsExact identifier
unii: O414PZ4LPZ
THESIS PHARMACY Alcohol Prep PadISOPROPYL ALCOHOLCarelife (USA) Inc.841d8b55-6383-4e02-9047-7b01e9f20a542026-03-24WarningsExact identifier
unii: ND2M416302
Salicylic AcidWART REMOVER MEDICATED DISCSCVS Pharmacy8560ca4c-f5e7-4473-a4ff-e4361366d7e72026-03-23WarningsExact identifier
unii: O414PZ4LPZ
WHAMISA ORGANIC PEAR BLOSSOM SUNSCREENZINC OXIDEENS KOREA Co., Ltd.34f9688d-efa1-1d3f-e063-6294a90ab1272026-03-23WarningsExact identifier
unii: O414PZ4LPZ
Flobow FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4d6fb8af-5641-4a9a-e063-6294a90abfa92026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Milia removerSALICYLIC ACIDGuangxi Keyun E-commerce Co., Ltd.4d6fd754-bfa0-d810-e063-6394a90a87422026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Milia removerSALICYLIC ACIDGuangxi Keyun E-commerce Co., Ltd.4d70063a-87a8-d623-e063-6294a90aaa132026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidGEL CORN REMOVERCVS Pharmacyf00d907a-f9ce-4463-827b-5a9f1fdb23da2026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKCVS Pharmacyc882379c-b011-4a38-827e-8cd7deef17122026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSCVS Pharmacy94f0766a-4623-4328-af3a-96b68c0881ea2026-03-20WarningsExact identifier
unii: O414PZ4LPZ
MG217 Psoriasis Therapeutic ConditionerSALICYLIC ACIDWisconsin Pharmacal Company246f239f-16fb-24b2-e054-00144ff8d46c2026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
unii: O414PZ4LPZ
Dermeleve Scalp Psoriasis TreatmentSALICYLIC ACIDAdvanced Derm Solutions LLCf55da7a8-0a26-4925-bd3b-fade6156116d2026-03-19WarningsExact identifier
unii: O414PZ4LPZ
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CALLUS REMOVERSCVS Pharmacy6e49633a-b600-40c4-855d-545c4982e36f2026-03-19WarningsExact identifier
unii: O414PZ4LPZ
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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