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 70 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
my beauty spot BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.cf36f10f-015d-491e-b8b9-99e130f67deb2025-08-01WarningsExact identifier
unii: O414PZ4LPZ
acne buster star patch 140 patches - Tea Tree Extract and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.a94c69ee-70e9-448b-aa8a-556fcbd638852025-08-01WarningsExact identifier
unii: O414PZ4LPZ
Zozdal Wart RemoverWART REMOVER SALICYLIC ACIDJiashen International Trade Limited3b387c89-25d5-f12b-e063-6294a90a59422025-07-31WarningsExact identifier
unii: O414PZ4LPZ
Caring Mill Alcohol Prep PadsISOPROPYL ALCOHOLFSA Store Inc.3b394791-0783-79e1-e063-6294a90ae8e72025-07-31WarningsExact identifier
unii: ND2M416302
Pert 2 in 1 Extra StrengthSALICYLIC ACIDSodalis USA, LLC25c8a46c-4400-709f-e063-6394a90a3f312025-07-30WarningsExact identifier
unii: O414PZ4LPZ
anti-fungalANTI-FUNGAL SHAMPOOGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd3b102d15-f2ce-5727-e063-6294a90a23a92025-07-29WarningsExact identifier
unii: O414PZ4LPZ
Earthmed Sport Anti itch and eczema reliefSALICYLIC ACIDEarthmed LLC3b14913b-3aab-9dd0-e063-6394a90a3b7f2025-07-29WarningsExact identifier
unii: O414PZ4LPZ
Soothing psoriasis and eczema reliefSALICYLIC ACIDCarolina Cannabis Creations L.L.C2bcad94d-1918-7f37-e063-6294a90a47442025-07-29WarningsExact identifier
unii: O414PZ4LPZ
Elsophie Wart Corn RemoverWART CORN REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.3b1e45b0-1d19-b280-e063-6294a90a7dd52025-07-29WarningsExact identifier
unii: O414PZ4LPZ
Clean and Clear Acne Spot TreatmentSALICYLIC ACIDKenvue Brands LLC098e0fcf-7640-e40a-e063-6394a90ac1ee2025-07-28WarningsExact identifier
unii: O414PZ4LPZ
Clean and Clear Acne Exfoliating CleanserSALICYLIC ACIDKenvue Brands LLC09a07037-4085-ee0a-e063-6394a90aa7142025-07-28WarningsExact identifier
unii: O414PZ4LPZ
The Inkey List 360 Acne Clearing SerumSALICYLIC ACIDBrand Evangelists for Beauty Limitede5c0e866-4dd8-43d0-abaf-2e2351eb57c72025-07-25WarningsExact identifier
unii: O414PZ4LPZ
Goodnites Skin tag and wart removerSALICYLIC ACID 17%Zhengzhou Hangrui Network Technology Co., Ltd.3aa79032-ca79-7780-e063-6294a90a91182025-07-24WarningsExact identifier
unii: O414PZ4LPZ
TACRUITF 17% Salicylic acid Wart Remover SerumSALICYLIC ACIDGuangzhou Borderless Technology Co., Ltd.3aa40886-b730-51f1-e063-6294a90a95342025-07-23WarningsExact identifier
unii: O414PZ4LPZ
Vryioh Wart RemoverWART REMOVER SALICYLIC ACIDJiashen International Trade Limited3a1bdfc9-8c0e-4b79-e063-6394a90a2c422025-07-17WarningsExact identifier
unii: O414PZ4LPZ
WISH 91% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLLJ Pharma449df7ac-97ac-41f3-a3c8-cf0d7c597e052025-07-17WarningsExact identifier
unii: ND2M416302
WISH RUBBING ALCOHOL 70%ISOPROPYL ALCOHOLLJ Pharmaedea3130-a766-4166-80b6-a93525f5a7372025-07-17WarningsExact identifier
unii: ND2M416302
Wart RemoverSALICYLIC ACIDWorld Perfumes Inc3a14cba2-c24d-5a28-e063-6394a90a5b702025-07-16WarningsExact identifier
unii: O414PZ4LPZ
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Incfd92c669-997e-4eea-b883-fe3486b83f312025-07-15WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 461225539cbe8-1d0f-41f8-9c5d-a9af7f28eed12025-07-15WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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