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 20 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EVEN KEEL RESURFACING PEELSALICYLIC ACIDPersonal Day Inc.330dd564-ebac-46f0-8c2a-34bbf60887d12026-05-20WarningsExact identifier
unii: O414PZ4LPZ
DOING THE WORK SALICYLIC ACID ACNE TREATMENTSALICYLIC ACIDPersonal Day Inc.4193a9ab-686a-494e-ade7-6e900e47e5b62026-05-20WarningsExact identifier
unii: O414PZ4LPZ
70% Isopropyl Alcohol70% ISOPROPYL ALCOHOLGreatdealson, Inc.4aa809cd-500a-dd65-e063-6394a90a31442026-05-20Warnings, Adverse reactionsExact identifier
unii: ND2M416302
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRockland Cosmetics, Inc.1bbae739-5e54-64cb-e063-6294a90a37452026-05-20Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Antiseptic MouthrinseEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRockland Cosmetics, Inc.b7c63ae5-08a8-436a-bbaa-f3ab3c2a5e672026-05-20Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
CVS Isopropyl Rubbing Alcohol WipesISOPROPYL ALCOHOLCVS PHARMACY, INC7e027210-9729-4659-8a75-b6b2ac60f7bc2026-05-19WarningsExact identifier
unii: ND2M416302
CVS Isopropyl Rubbing Alcohol PadsISOPROPYL ALCOHOLCVS PHARMACY, INCe65b3363-71d9-47b6-a044-edac18f9858f2026-05-19WarningsExact identifier
unii: ND2M416302
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc434ab915-faa3-40a7-8f8d-ff0eeef95e1f2026-05-19WarningsExact identifier
unii: O414PZ4LPZ
MORKORIA BEE VENOM WART REMOVERSALICYLIC ACID 17% BEE VENOM 1% BEE VENOM WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a1e3a7a-0570-a95f-e063-6394a90adbc72026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidCALLUS REMOVERSPremier Brands of America Inc.0b637f58-5604-454d-99ba-24115113ac3d2026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Skin Tag RemoveSKIN TAG REMOVEShenzhen Earth Surface Trading Co., Ltd.5224362c-967e-9b98-e063-6294a90a98672026-05-18WarningsExact identifier
unii: O414PZ4LPZ
Wish Alcohol PadISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.51f87ed7-04ae-136a-e063-6294a90a95002026-05-16WarningsExact identifier
unii: ND2M416302
Alcohol prep padISOPROPYL ALCOHOL CLOTHHubei V-Medical Products co.,Ltd.51d5780e-9039-1b66-e063-6394a90a0b8a2026-05-15WarningsExact identifier
unii: ND2M416302
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4e91983f-4570-3a56-e063-6394a90a38f22026-05-15WarningsExact identifier
unii: ND2M416302
Swab Applicator Brushes 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c34af0-2b12-c5e0-e063-6394a90a41742026-05-14WarningsExact identifier
unii: ND2M416302
Clean and Clear Essentials Dual Action MoisturizerSALICYLIC ACIDKenvue Brands LLC0a3c7897-c6c8-adb6-e063-6294a90aed482026-05-14WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLCe3d5538a-51be-0ebe-e053-2995a90a6d152026-05-14WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil Free Acne Moisturizer Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC0eda5e12-297f-4049-90f6-540f5a1d17912026-05-14WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl AlcoholISOPROPYL ALCOHOLChain Drug Marketing Associationf5b99c4b-1f4b-40be-bae7-59aa92c5b52c2026-05-14Warnings, Adverse reactionsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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