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 64 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Salicylic AcidLIQUID CORN AND CALLUS REMOVERFSA Store Inc.3cd18e4c-26c1-1548-e063-6294a90acdb02025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID CORN AND CALLUS REMOVERFoodhold USA966889e5-65d9-4057-ac7d-0f985e7c67342025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Liquid Callus RemoverSALICYLIC ACIDPremier Brands of America Inc.051c7917-76ea-c7f8-e063-6394a90a9e362025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidCORN AND CALLUS REMOVERGeiss, Destin & Dunn, Inc.21b8d34d-1127-4b0d-b853-0349f25cc91f2025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID CORN AND CALLUS REMOVERHarris Teeter, LLC27a1c74d-f983-4e18-9854-7a83c3365c852025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidCORN AND CALLUS REMOVER KITKroger Co.c63a4d29-76e2-4d20-8671-e01311ca30902025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Liquid Corn and Callus RemoverSALICYLIC ACIDMeijer Distribution Inc039c3dbe-97ba-805c-e063-6394a90a91e82025-10-08WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID CORN AND CALLUS REMOVERWalgreen Company8305ee69-3940-43e8-b6bb-b6438a14ef5c2025-10-08WarningsExact identifier
unii: O414PZ4LPZ
PurPrepPOVIDONE IODINE AND ISOPROPYL ALCOHOLCareFusion 213 LLCa1c6e118-7861-c8d0-e053-2995a90aeaaa2025-10-08WarningsExact identifier
unii: ND2M416302
MediChoice Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLO&M HALYARD, INC.8b84c8ed-040e-4c07-94cb-d5bdda7446482025-10-08WarningsExact identifier
unii: ND2M416302
equate SwabsticksISOPROPYL ALCOHOLWalmart Inc.cd4a4490-bb02-436d-853b-f73261d358c62025-10-07WarningsExact identifier
unii: ND2M416302
Starface Acne Spot TreatmentSALICYLIC ACIDStarface World, Inc.f8cfd5b0-317e-4646-9885-71ecad29ba1c2025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID WART REMOVERHudson Health LLC63b62a7a-1082-4323-bf44-810545792de92025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID WART REMOVERFoodhold USAcbef086c-2499-4fd6-bfee-7db521a7150f2025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID WART REMOVERFSA Store Inc.3cd18f96-34f9-3f2c-e063-6294a90a3b7e2025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVER LIQUIDDiscount Drug Mart06fa816a-4963-46d9-9471-9f9ac1abc9202025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID WART REMOVERAmerisourceBergen5ac7242f-399a-4513-8932-90e5285ccb9f2025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVER LIQUIDARMY & AIR FORCE EXCHANGE SERVICE50d4bb37-db63-4d92-86a3-b4a43f36f9cd2025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVER LIQUIDHarris Teeter, LLCd53756d4-6739-48da-b367-84531f9891702025-10-07WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidWART REMOVER LIQUIDKroger Co.fc4a7586-2ec4-4528-816f-075d77734bff2025-10-07WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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