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 99 of 119 · 2,370 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLBecton Dickinson and Company7ae72375-ffed-42c8-9506-051861ea68fc2024-10-03WarningsExact identifier
unii: ND2M416302
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLNavajo Manufacturing Company Inc.f5f26e2f-8a1f-4687-e053-2a95a90ae3782024-10-03WarningsExact identifier
unii: RV6J6604TK
Atrix Clarifying TonerSALICYLIC ACIDPureTek Corporation191a2f96-eb97-4b45-b6a8-0d5835e7e7572024-10-02WarningsExact identifier
unii: O414PZ4LPZ
CornStickSALICYLIC ACIDBalassa Laboratories Inc.c453b06e-f9b0-4099-949a-6f5d2a8577e82024-10-01WarningsExact identifier
unii: O414PZ4LPZ
ZO Skin Health Retinol Plus Acne ComplexSALICYLIC ACIDZO Skin Health, Inc.1d65e4d2-0856-9135-e063-6294a90a5c662024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Atrix Acne TreatmentSALICYLIC ACIDPureTek Corporationba106b20-32aa-df90-e053-2995a90adaef2024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Atrix Antibacterial WashSALICYLIC ACIDPURETEK CORPORATIONbd5b6f29-5b97-0853-e053-2a95a90aed592024-10-01WarningsExact identifier
unii: O414PZ4LPZ
WartStick PlantarSALICYLIC ACIDBalassa Laboratories Inc.dfe2aa35-d780-4ae8-b230-019ec2e1a5c72024-10-01WarningsExact identifier
unii: O414PZ4LPZ
Target Up and Up Salicylic Acid Acne WashSALICYLIC ACIDTARGET CORPORATION235aa04e-746f-d66a-e063-6394a90a11442024-09-30WarningsExact identifier
unii: O414PZ4LPZ
Target Up and Up Moisturizer with Salicylic Acid Acne TreatmentSALICYLIC ACIDTARGET CORPORATION235ca067-e2d4-ca01-e063-6394a90a10502024-09-30WarningsExact identifier
unii: O414PZ4LPZ
Acne Phage SerumENCAPSULATED SALICYLIC ACIDAllure Labs230d173f-92c1-2e98-e063-6394a90acb212024-09-26WarningsExact identifier
unii: O414PZ4LPZ
CVS Health MAXIMUM STRENGTH Therapeutic Dandruff Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDCVS Healthbd32def7-b002-4e12-89ad-b7d13754d82a2024-09-24WarningsExact identifier
unii: O414PZ4LPZ
Topicals Clearly MistSALICYLIC ACIDTopiderm, Inc.1f1d6751-9566-4738-a28b-f501425b6b212024-09-24WarningsExact identifier
unii: O414PZ4LPZ
Aveeno Positively Radiant Clear Complexion Daily MoisturizerSALICYLIC ACIDKenvue Brands LLCe426681d-9738-c7ab-e053-2a95a90a9ab32024-09-23WarningsExact identifier
unii: O414PZ4LPZ
Samsali Wart Corn Remover PadsWART CORN REMOVER PADSShenzhen Xinxin Yunhai Technology Co., Ltd.186314fe-9438-b1f5-e063-6294a90a99032024-09-19WarningsExact identifier
unii: O414PZ4LPZ
MDacne Customized Acne Treatment Salicylic AcidSALICYLIC ACIDMDAlgorithms Inc3eae8b39-d2c2-4cf7-8c56-7fbaec481fc72024-09-19WarningsExact identifier
unii: O414PZ4LPZ
MDacne Customized Acne Cleanser Hydrating Salicylic AcidSALICYLIC ACIDMDAlgorithms Incff01a623-327d-4350-819f-68188c82b9122024-09-19WarningsExact identifier
unii: O414PZ4LPZ
WalmartISOPROPYL ALCOHOLWalmart Inc.d2b9f182-c341-c3b0-e053-2a95a90ac5a72024-09-18WarningsExact identifier
unii: ND2M416302
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC2216a551-9fbe-3721-e063-6294a90af13d2024-09-14WarningsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLembecta Medical II, LLCe9576c62-6b6e-4c51-a162-0f93f7ffd7dd2024-09-13WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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