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 42 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
unii: ND2M416302
EVERLIT SURVIVAL PREP PADISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a03ed81-5b1d-172e-e063-6394a90ac59c2026-01-23WarningsExact identifier
unii: ND2M416302
Skinkure Acne Eraser Spot TreatmentSALICYLIC ACIDSKINKURE, LLC0fc85727-4321-7750-e063-6294a90ad3fe2026-01-23WarningsExact identifier
unii: O414PZ4LPZ
EmuaidSALICYLIC ACIDSpeer Laboratories, LLCa1486276-30f7-4245-815b-d57edf411cda2026-01-23WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Evenly Clear Acne CleanserSALICYLIC ACIDKenvue Brands LLC3e985a61-2aa7-963b-e063-6294a90a7c122026-01-22WarningsExact identifier
unii: O414PZ4LPZ
Rite Aid Isopropyl Alcohol WipesISOPROPYL ALCOHOLRite Aidbca837b0-5044-4e97-e053-2a95a90a13af2026-01-22WarningsExact identifier
unii: ND2M416302
Resurfacing acne swipesSALICYLIC ACIDSKIN PS Brands9629fdcb-f3b5-9685-e053-2a95a90a02302026-01-22WarningsExact identifier
unii: O414PZ4LPZ
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare Facial ScrubSALICYLIC ACIDSpa de Soleil025d4242-9e7d-9ba1-e063-6294a90af7522026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare PadsSALICYLIC ACIDSpa de Soleil025d79e9-3aeb-40b9-e063-6394a90a48a42026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare MoisturizerSALICYLIC ACIDSpa de Soleilf81834b7-672d-4411-e053-6394a90aeada2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Dermatouch Acnecare CleanserSALICYLIC ACIDSpa de Soleile3514af1-f9b9-c251-e053-2a95a90ac80e2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidMEDICATED CORN REMOVERSWal-Mart Stores Inc80c4907d-d4ea-42b0-e053-2a91aa0a173c2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
Lights Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLLights Medical Manufacture Co., Ltd.4905a27c-6cf8-4b1a-a02c-4c81756e8c0a2026-01-21WarningsExact identifier
unii: ND2M416302
LIGHTS Instant Sting Relief PadBENZOCAINELights Medical Manufacture Co., Ltd.28dd82a7-f360-a022-e063-6394a90a3a762026-01-21WarningsExact identifier
unii: ND2M416302
DOP Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLOmega & Delta Co., Inc.c779a35b-1118-4560-8d77-6878edb4c2672026-01-21WarningsExact identifier
unii: ND2M416302
Therapeutic TPlus Salicylic Acid Anti-dandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACIDGarcoa, Inc.620617e3-0ee1-469a-ad2b-0dda957627cc2026-01-21WarningsExact identifier
unii: O414PZ4LPZ
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Salicylic AcidCORN REMOVERSWalgreen Company249ba77f-fba4-41b4-83df-3f46fb94835a2026-01-20WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidEXTRA THICK CALLUS REMOVERSWalgreen Companyfa2e95b5-fe90-4406-b981-05bca62fd25c2026-01-20WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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