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 67 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic Acid 2% SolutionSALICYLIC ACIDDeciem39fa19ee-9cc8-8fbc-e063-6394a90a96df2025-09-09WarningsExact identifier
unii: O414PZ4LPZ
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus Alcohol Wipes70% ISOPROPYL ALCOHOLUnifirst First Aid Corporation3f507990-282a-4b26-e054-00144ff8d46c2025-09-08WarningsExact identifier
unii: ND2M416302
Green Guard Sterile Alcohol WipesISOPROPYL ALCOHOL 70%Unifirst First Aid Corporation570baa70-e519-328b-e054-00144ff8d46c2025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce650cb6-5398-29e7-e053-2995a90ac7972025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Sting ReliefBENZOCAINE 6%, ISOPROPYL ALCOHOL 60%Unifirst First Aid Corporation6e610821-b030-930b-e053-2a91aa0a66f92025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Isopropyl AlcoholISOPROPYL ALCOHOLUnifirst First Aid Corporationdbee035e-094f-f8a3-e053-2995a90a66202025-09-08WarningsExact identifier
unii: ND2M416302
Medi-First Isopropyl Alcohol 70%ISOPROPYL ALCOHOLUnifirst First Aid Corporationdbfbf8cf-201b-2277-e053-2995a90a6e452025-09-08WarningsExact identifier
unii: ND2M416302
Green Guard Alcohol WipesISOPROPYL ALCOHOLUnifirst First Aid Corporationce6992d8-037f-61c7-e053-2a95a90ad0b02025-09-08WarningsExact identifier
unii: ND2M416302
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Ology Acne SpotSALICYLIC ACIDWalgreens Co.59a97686-04c0-4d53-9efd-19a1c3ece2d82025-09-05WarningsExact identifier
unii: O414PZ4LPZ
PHOFAY Salicylic Acid Acne Treatment EssenceSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.1a03c857-1040-44ea-817d-7b472160ba6b2025-09-04WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVER PATCHESSALICYLIC ACID 12%Shenzhen Finona Information Technology Co., Ltd3db92ae2-aabd-db2f-e063-6394a90aa6692025-09-01WarningsExact identifier
unii: O414PZ4LPZ
BioreSALICYLIC ACIDKao USA Inc.2e1e1aa2-5d41-baa4-e063-6394a90ac3f22025-08-31WarningsExact identifier
unii: O414PZ4LPZ
AeroWipeSTING RELIEF PADAero Healthcare US LLC3d851c98-c9b9-f084-e063-6294a90acde22025-08-29WarningsExact identifier
unii: ND2M416302
Biore Pore Unclogging ScrubSALICYLIC ACIDKao USA Inc.5667307e-0bab-41c3-a2d6-5ca8605468332025-08-28WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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