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 43 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidCLEAR MEDICATED CORN REMOVERSWalgreens Companyf691fbf6-5e74-bac8-e053-2a95a90a67142026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidULTRA THIN CORN REMOVERSWalgreens Company822c6cbe-15a7-4183-b28b-f00a1d2c85242026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVERSWalgreen Company5ef4636b-9ff1-4ac5-818d-4fd547de7de62026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED PLANTAR WART REMOVERMeijer Distribution Inc1bb76c71-76eb-4eb9-abbf-414e52a133d32026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Oil Free Daily Face EQBSALICYLIC ACID 2%Walmart039d3187-b8d6-3613-e063-6294a90a9b152026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Acne ScrubSALICYLIC ACIDSpa de Soleil0a9067f7-2a9d-abae-e063-6394a90a35332026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Acne CleanserSALICYLIC ACIDSpa de Soleil0a90a5e9-65e7-f885-e063-6394a90a8bf82026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Acne MoisturizerSALICYLIC ACIDSpa de Soleil0a9047c8-2038-7c92-e063-6294a90a59982026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Acne Care LotnSALICYLIC ACIDSpa de Soleil0a90dd85-06d1-13e0-e063-6394a90af2b62026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Equate 2% Salicylic acid Acne treatment pad2% SALICYLIC ACIDWalmart, Inc.c83c9a42-796a-f322-e053-2995a90a4be92026-01-19WarningsExact identifier
unii: O414PZ4LPZ
SCANTILY PADACNE TREATMENTDermala Incc5145f1d-78f7-22b4-e053-2a95a90a5c592026-01-19WarningsExact identifier
unii: O414PZ4LPZ
ACNE TREATMENT PADSACNE TREATMENT PADSShenzhen Hengdasheng Technology Co., Ltd47b6edd6-180f-a62f-e063-6294a90aad352026-01-17WarningsExact identifier
unii: O414PZ4LPZ
CORN REMOVERCORN REMOVERShenzhen Hengdasheng Technology Co., Ltd47f36a54-a1f2-e96e-e063-6294a90a90692026-01-17WarningsExact identifier
unii: O414PZ4LPZ
Retexturizing Body PadsSALICYLIC ACIDMurad, LLCe0bb5a87-6bf7-4273-b7dc-2b59270829772026-01-16WarningsExact identifier
unii: O414PZ4LPZ
Zapzyt Acne Wash CleanserSALICYLIC ACIDFocus Consumer Healthcare, LLC6078c812-947f-3be0-e053-2a91aa0aafb02026-01-16WarningsExact identifier
unii: O414PZ4LPZ
NEXXGEN 50% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCd48232ab-ab55-488a-9cc1-77c8d0ba992e2026-01-16WarningsExact identifier
unii: ND2M416302
MAX COMPLEXION CORRECTION PADSSALICYLIC ACIDPETER THOMAS ROTH LABS LLC4870f872-0802-7f08-e063-6394a90a19e92026-01-15WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CALLUS REMOVERSVALU MERCHANDISERS, CO468fd593-8b40-41b2-b419-d6550ed625412026-01-15WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSVALU MERCHANDISERS, COee15daa4-3325-4b16-8f84-ac7d39fa0aec2026-01-15WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidMEDICATED CALLUS REMOVERS EXTRA THICKVALU MERCHANDISERS, COdd3c2727-e250-4a35-9256-856a775b948b2026-01-15WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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