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 48 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alcohol padsALCOHOL PADSSHENZHEN BENLIJU BIO-TECH CO.,LTD1b9ab5f4-4e4a-19e5-e063-6294a90ae3e62026-01-05WarningsExact identifier
unii: ND2M416302
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: O414PZ4LPZ
PanOxyl Acne Banishing Body (Spray)SALICYLIC ACIDCrown Laboratories, Inc.2305f297-665d-e55f-e063-6394a90aa14e2026-01-05WarningsExact identifier
unii: O414PZ4LPZ
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENTSALICYLIC ACIDSHISEIDO AMERICAS CORPORATION3b584705-21a8-4e37-96cc-f9c8058db5c42026-01-05WarningsExact identifier
unii: O414PZ4LPZ
IDOSWAB BISOPROPYL ALCOHOLIDO PHARM16d19630-b67a-f3e1-e063-6394a90a74292026-01-05WarningsExact identifier
unii: ND2M416302
Sure Comfort Alcohol Prep PadsISOPROPYL ALCOHOLIDO PHARM27def94b-d3a6-18b7-e063-6394a90a22a62026-01-05WarningsExact identifier
unii: ND2M416302
ProBliva Anti Fungal Shampoo.ANTIFUNGALCAVTECH HOLDING LLC47af9ff8-5d5c-4524-e063-6394a90ac91f2026-01-05WarningsExact identifier
unii: O414PZ4LPZ
Wart Remover LiquidSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.47783ab1-5e0d-1cc1-e063-6294a90aac332026-01-03WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSAmerisourceBergen Drug Corporationf407f14a-7c5c-481d-b1d1-1ea94b3a30292026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSHarris Teeter, LLC0a8f8a45-bf6c-4a1e-9170-cf5b86581f162026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERHY-VEE, INC415f61b8-152e-7c4c-e063-6394a90a56792026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSKroger Co.b5027cdf-d4d1-4e7b-bb02-967675a5c61c2026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Mens Rogaine 2% Salicylic Acid Anti-Dandruff Plus ConditionerSALICYLIC ACIDKenvue Brands LLC44906677-88a2-7c68-e063-6294a90a30172026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidCORN REMOVERSPremier Brands of America Inc.f5b9f494-e4c9-40b9-93a5-4b8c03cc598b2026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Corn RemoversSALICYLIC ACIDWinCo Foods LLC15d7cce9-cf52-f417-e063-6394a90af9fc2026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSHudson Health LLC6168e9a0-48df-4033-a6fc-17ec2895574f2026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Medicated Callus Removers Extra ThickSALICYLIC ACIDMeijer Distribution Inc039bcd7d-9a71-a1aa-e063-6294a90a09532026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERSUnited Natural Foods, Inc. dba UNFIbdb567a7-77d0-49d7-be63-0c6a4aaa21cf2026-01-02WarningsExact identifier
unii: O414PZ4LPZ
Alcohol PadISOPROPYL ALCOHOLYiwu Ori-Power Medtech Co.,Ltd.74dc43d1-2aba-4f8a-876a-ce712ad37eeb2026-01-01WarningsExact identifier
unii: ND2M416302
I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSERSALICYLIC ACIDMemebox Corporation297bbe36-23be-0995-e063-6294a90a98df2026-01-01WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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