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 40 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationd55d4101-be0c-47d9-a2ad-d3d30516bf042026-01-30Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Isopropyl AlcoholISOPROPYL ALCOHOLRite Aid Corporationc074bbaf-2fd7-485a-9e22-a368d8dd47012026-01-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLRite Aid Corporationa21eef4f-62a5-4f40-8a52-dd581577f7f92026-01-30Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Alveora CORN WART REMOVERALVEORA CORN WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD49a7e214-74b8-0cbd-e063-6394a90a2e9c2026-01-30WarningsExact identifier
unii: O414PZ4LPZ
Acne TreatmentSALICYLIC ACIDNatureplex, LLC31b50718-cc60-460d-aad7-b9620970d4112026-01-29WarningsExact identifier
unii: O414PZ4LPZ
NATUREPLEX PSORIASISSALICYLIC ACIDNatureplex, LLC1efa3e8d-f80b-44f4-a233-187e3329dd8f2026-01-29WarningsExact identifier
unii: O414PZ4LPZ
LXHUKU WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4982e90f-cdc4-6364-e063-6294a90a8e522026-01-29WarningsExact identifier
unii: O414PZ4LPZ
OJIOG WART CORN REMOVERSALICYLIC ACID 17% WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD49834b14-fb5e-f180-e063-6394a90a832d2026-01-29WarningsExact identifier
unii: O414PZ4LPZ
Reaua BEE VENOM TAG WART REMOVERSALICYLIC ACID 16% BEE VENOM 1% BEE VENOM TAG WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4983acc5-9ff1-5676-e063-6394a90ad87a2026-01-29WarningsExact identifier
unii: O414PZ4LPZ
Reaua Genital Warts RemoverREAUA GENITAL WARTS REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4983fe22-3c4e-c7ad-e063-6394a90ad00b2026-01-29WarningsExact identifier
unii: O414PZ4LPZ
vkavka Wart RemoverSALICYLIC ACIDShenzhen Lanxi Trading Co., Ltd.4984a43e-1dfd-1493-e063-6294a90aab9d2026-01-29WarningsExact identifier
unii: O414PZ4LPZ
Peace Out Acne CleanserSALICYLIC ACIDPeace Out LLC0a8897b0-cb8f-ba50-e063-6394a90a7f342026-01-29WarningsExact identifier
unii: O414PZ4LPZ
Peace Out Acne MoisturizerSALICYLIC ACIDPeace Out LLC.18bb4314-0b18-b3bc-e063-6294a90a18542026-01-29WarningsExact identifier
unii: O414PZ4LPZ
WISH RUBBING ALCOHOL 50%ISOPROPYL ALCOHOLLJ Pharma15b4a45d-3dbf-48e4-8f90-15dca7e650d92026-01-29WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 50% Winter GreenISOPROPYL ALCOHOLLJ Pharmafbb45bde-b733-4524-bfa9-ae819ad399732026-01-29WarningsExact identifier
unii: ND2M416302
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL7-Eleven5625ac4e-aa37-41b5-80b7-67b223707ccf2026-01-29Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAldi, Inc08aef3fa-f863-4716-ac72-1d7bfcc0d6ef2026-01-29Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
WalmartISOPROPYL ALCOHOLWalmart Inc.1d75799d-081e-a38b-e063-6294a90adf352026-01-29WarningsExact identifier
unii: ND2M416302
IRISISOPROPYL ALCOHOLAmerifoods Trading Co100e0c3d-96eb-44af-8684-df45a8ab30652026-01-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Eucalyptol, Menthol, Methyl Salicylate, ThymolEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLAMERISOURCE BERGEN02ffe892-732b-4798-9ea8-ca646c37f3002026-01-29Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK

Reported adverse events (FAERS/openFDA)#

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