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 21 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
91% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf10995fd-fe94-436a-8783-4cdf10438d752026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70% Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationc07b7f1b-eda2-4f0f-a35d-f34ac85abab32026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl alcoholISOPROPYL ALCOHOLHARRIS TEETERb3fa1454-25cd-4801-bbec-5da43a70ec7f2026-05-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLHARRIS TEETERc4e816c7-a8a2-404c-9354-eaaed6dbf0f52026-05-14WarningsExact identifier
unii: ND2M416302
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula TonerSALICYLIC ACIDL'Oreal USA Products Inca2dc3cf4-23d2-4cb7-8fdc-615420db57102026-05-14WarningsExact identifier
unii: O414PZ4LPZ
Wart Remover PatchesSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.51b385fe-7abc-839d-e063-6394a90a79fc2026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Clearasil Rapid Rescue Deep Treatment PadsSALICYLIC ACIDReckitt Benckiser LLC2387e74a-312c-44bf-bda5-fc4ec1ce62082026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Clearasil Rapid Rescue Deep Treatment WashSALICYLIC ACIDReckitt Benckiser LLC1745fb36-5394-46cd-bc49-d5fe32b74e212026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Clearasil Stubborn Acne Control 5in1 Daily PadsSALICYLIC ACIDReckitt Benckiser LLC17875670-ca6a-4dc3-97c2-c8d1f85d4d552026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Clearasil Stubborn Acne Control 5in1 Exfoliating WashSALICYLIC ACIDReckitt Benckiser LLC39eb1104-e3f4-4c25-9686-dcfb6456393e2026-05-13WarningsExact identifier
unii: O414PZ4LPZ
HEALMUSZ WART REMOVERSALICYLIC ACID 10% WART REMOVERJiangxi Zhongletang Pharmaceuticals Co.,Ltd.519c9353-e64a-3c86-e063-6294a90a74a72026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Lixuhya MILIA REMOVER ESSENCESALICYLIC ACID 1% MILIA REMOVER ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD51872c01-804c-a29f-e063-6294a90ae5462026-05-13WarningsExact identifier
unii: O414PZ4LPZ
Lightning X Sting and Bite Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.518698c0-a1ae-760f-e063-6394a90a51602026-05-11WarningsExact identifier
unii: ND2M416302
Liquid WART CORN REMOVERSALICYLIC ACIDJiangxi Zhangling Industrial Co., Ltd.5196dcfc-700b-e94c-e063-6294a90a147f2026-05-11WarningsExact identifier
unii: O414PZ4LPZ
caring mill Lavender Alcohol WipesISOPROPYL ALCOHOLFSA Store Inc.fcbb6b34-6f0e-4b82-8b3f-1d702d88079a2026-05-11WarningsExact identifier
unii: ND2M416302
Kopa Haiku Seborrheic Dermatitis Face CreamSALICYLIC ACID 0.5% AND ZINC PYRITHIONE 0.25%Trovina Co. Ltd483450d2-e38b-56ec-e063-6394a90acb5b2026-05-10WarningsExact identifier
unii: O414PZ4LPZ
Premier Solutions Liquid Corn and Callus RemoverSALICYLIC ACIDPremier Brands of America Inc.e16d0256-1151-8394-e053-2995a90ab56c2026-05-08WarningsExact identifier
unii: O414PZ4LPZ
Premier Solutions Wart RemoversSALICYLIC ACIDPremier Brands of America Inc.5150b3be-b367-7f74-e063-6294a90a6f622026-05-08WarningsExact identifier
unii: O414PZ4LPZ
EquateSALICYLIC ACIDWalmart INC2643feb4-7a29-ef9f-e063-6394a90aec8a2026-05-08WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC51352d8d-f84e-20dc-e063-6294a90a20d52026-05-07WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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