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 68 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Goodnites skin tag removerSALICYLIC ACIDZhengzhou Hangrui Network Technology Co., Ltd.364268ef-97e9-068f-e063-6294a90a1f2b2025-08-27WarningsExact identifier
unii: O414PZ4LPZ
PHOFAY ACNE SPOTTREATMENT CreamSALICYLIC ACIDHangzhou Jingshen Trading Co., Ltd.3d40c687-7110-46b1-e063-6394a90a84162025-08-26WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidCORN AND CALLUS REMOVER KITVALU MERCHANDISERS, COd37b1c38-2805-40e1-875b-85bb40914c802025-08-26WarningsExact identifier
unii: O414PZ4LPZ
Propolis Wart Remover StickSALICYLIC ACIDRida LLC57ef6638-95e9-48d6-97b7-0ec762e469a12025-08-25WarningsExact identifier
unii: O414PZ4LPZ
PHOFAY ACNE SPOT TREATMENT CreamSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.3d0511f6-168b-5377-e063-6294a90a3ca92025-08-23WarningsExact identifier
unii: O414PZ4LPZ
OP-First Aid Series ALCOHOL PREP PADS STERILEISOPROPYL ALCOHOL CLOTHYiwu Ori-Power Medtech Co.,Ltd.351f4b1e-75c9-abec-e063-6294a90a28752025-08-22WarningsExact identifier
unii: ND2M416302
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
unii: ND2M416302
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLJell Pharmaceuticals Pvt. Ltd.3cf2ff12-0220-3307-e063-6394a90abf082025-08-22WarningsExact identifier
unii: ND2M416302
Chain Drug Marketing Association, Inc.ISOPROPYL ALCOHOLChain Drug Marketing Association Inc.18fe4787-8986-4d64-e063-6394a90a35132025-08-22WarningsExact identifier
unii: ND2M416302
PAPATUI Acne Fighting BodySALICYLIC ACIDPAPATUI, LLC3cf9ec1a-4ac3-fceb-e063-6294a90a21a02025-08-22WarningsExact identifier
unii: O414PZ4LPZ
PAPATUI Acne Fighting Facial CleanserSALICYLIC ACIDPAPATUI, LLC3cfadbb6-fc5e-5696-e063-6394a90a21f42025-08-22WarningsExact identifier
unii: O414PZ4LPZ
AMERICAN REDCROSS 70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLCd4d7d0e8-12b4-e410-e053-2a95a90a7f302025-08-21WarningsExact identifier
unii: ND2M416302
Neutrogena Oil-Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLC3cc657cd-ad68-505a-e063-6394a90a41b22025-08-20WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC3cc7eeb1-972c-25ec-e063-6294a90ae9292025-08-20WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil-Free Acne Wash Daily ScrubSALICYLIC ACIDKenvue Brands LLC3ccd4c1b-3784-f767-e063-6294a90a35432025-08-20WarningsExact identifier
unii: O414PZ4LPZ
Ragkun WART REMOVERSALICYLIC ACIDJiashen International Trading Co., Ltd.3ccea52e-c900-8ffb-e063-6294a90ae75b2025-08-20WarningsExact identifier
unii: O414PZ4LPZ
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edaff0ca-f305-71a4-e053-2a95a90a5dca2025-08-18WarningsExact identifier
unii: ND2M416302
Non-proprietary nameALCOHOL PREP PADGuangzhou Four E's Scientific Co., Ltd.edb4a43a-5b55-3404-e053-2a95a90ada272025-08-18WarningsExact identifier
unii: ND2M416302
Neutrogena Oil-Free Acne Wash Cream CleanserSALICYLIC ACIDKenvue Brands LLC3c9e91bf-664a-9341-e063-6294a90a7fca2025-08-18WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil-Free Acne Stress Control Power-Cream WashSALICYLIC ACIDKenvue Brands LLC3ca05f64-0b97-59b7-e063-6394a90ac5d82025-08-18WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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