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 81 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10SALICYLIC ACIDKenvue Brands LLC16aa0a68-b787-4f82-e063-6394a90ad38a2025-02-17WarningsExact identifier
unii: O414PZ4LPZ
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Corn remover padsCORN REMOVER PADSHenan Shouerkang Health Industry Co., Ltd2e617119-531d-af7b-e063-6294a90a8ca62025-02-17WarningsExact identifier
unii: O414PZ4LPZ
50 percent Isopropyl alcoholISOPROPYL ALCOHOLWhole Foods Market6cb4ccca-96e7-43cb-ae05-95a411e712552025-02-14WarningsExact identifier
unii: ND2M416302
Witch Hazel Pore Clarifying Toner 8 ozSALICYLIC ACID 2%Ningbo Rejoice International99748785-8321-7bbf-e053-2a95a90a16c92025-02-13WarningsExact identifier
unii: O414PZ4LPZ
Rubbing Alcohol 91 percent isopropylISOPROPYL ALCOHOLWinCo Foods, LLC0ce2110d-ea9d-4d41-b0ae-6e9182f25abc2025-02-12WarningsExact identifier
unii: ND2M416302
TTSIYA WART REMOVERWART REMOVERJiashen International Trade Limited2ddf982a-e9ed-915d-e063-6394a90a78972025-02-11WarningsExact identifier
unii: O414PZ4LPZ
YOUR Anti-Acne Body WashSALICYLIC ACIDSkin Ai, LLC2cb4d4ea-a1f2-19ef-e063-6394a90ac7502025-02-10WarningsExact identifier
unii: O414PZ4LPZ
Prevantics SwabstickCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLProfessional Disposables International, Inc.9841200b-d4c6-b40c-e053-2995a90a55962025-02-10WarningsExact identifier
unii: ND2M416302
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products, Inc.2d90c8e8-f479-3535-e063-6394a90af1222025-02-07WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products BM123COCCINELLA, GNAPHALIUM POLY, HYDROCOTYLE, SALICYLIC ACID, SYPHILINUMBestmade Natural Products2d93946d-990c-6bc1-e063-6294a90adbcb2025-02-07WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLGood Sense (Geiss, Destin & Dunn, Inc.)ac66be77-d358-44ea-8904-88186a7c2bbb2025-02-07WarningsExact identifier
unii: ND2M416302
Rubbing Alcohol 70 Percent IsopropylISOPROPYL ALCOHOLHarris Teeter, LLC4196dd97-9041-4712-8196-02237a3b0cb22025-02-07WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLHarris Teeter, LLC1b044f47-45e1-40a3-81b0-2717ed425f162025-02-07WarningsExact identifier
unii: ND2M416302
Neutrogena Rapid Clear Treatment PadsSALICYLIC ACIDKenvue Brands LLCec139967-e448-a9cb-e053-2995a90aed6e2025-02-06WarningsExact identifier
unii: O414PZ4LPZ
Acne wash facial cleanser pink grapefruitSALICYLIC ACIDRejoice International Corp390528bf-d536-157a-e054-00144ff88e882025-02-06WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcohol 70 percent WintergreenISOPROPYL ALCOHOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)444cd7f4-cf61-49b6-a93e-915d250838da2025-02-06WarningsExact identifier
unii: ND2M416302
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLDolgencorp, Inc. (DOLLAR GENERAL & REXALL)444883fc-7ae4-4dd3-bd2b-f94c3265c1702025-02-05WarningsExact identifier
unii: ND2M416302
PHARMACIST CHOICE ALCOHOL STERILE PREP PADISOPROPYL ALCOHOLSimple Diagnostics0fc4a4b2-342b-5948-e054-00144ff88e882025-02-04WarningsExact identifier
unii: ND2M416302
Acne Biotic MoisturizerSALICYLIC ACIDDermalogica, LLC.ee181358-7f51-413f-9f6b-27ce9778bd072025-02-04WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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