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 52 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scholls Wellness Company LLC One Step Corn RemoversSALICYLIC ACIDScholls Wellness Company LLC7f98d59c-fc89-545b-e053-2a91aa0a49e62025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Scholls Wellness Company LLC DURAGEL CORN REMOVERSALICYLIC ACIDScholls Wellness Company LLCb7249271-0561-db00-e053-2995a90ac0222025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Clear Away Wart RemoversSALICYLIC ACIDScholls Wellness Company LLCfc9c4996-302e-2ad8-e053-6294a90a5f382025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Scholls Wellness Company LLC Duragel Callus RemoverSALICYLIC ACIDScholls Wellness Company LLCb7256b0a-3c7e-139f-e053-2a95a90ad3442025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Scholls Wellness Company LLC DS EXTRA THICK CALLUS REMOVERSALICYLIC ACIDScholls Wellness Company LLCb7144150-6c81-66c2-e053-2995a90ad6e92025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Plantar Wart RemoversSALICYLIC ACIDScholls Wellness Company LLCfc9dc984-37c8-5bab-e053-6294a90a3c152025-12-21WarningsExact identifier
unii: O414PZ4LPZ
Quality Choice PsoriasisSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd4651cabb-98ee-a257-e063-6294a90afd3b2025-12-19WarningsExact identifier
unii: O414PZ4LPZ
Quality Choice TherapeuticSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd465215fc-3648-152c-e063-6294a90ad4882025-12-19WarningsExact identifier
unii: O414PZ4LPZ
RoyceDerm Tea Tree TherapeuticSALICYLIC ACID 3%RoyceDerm LLC46542754-2256-a23c-e063-6394a90a77952025-12-19WarningsExact identifier
unii: O414PZ4LPZ
Breakout Clearing BoosterSALICYLIC ACIDDermalogica, LLC.6ec73c30-a5cc-4937-aa7e-714f53ef24082025-12-18WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
First Aid Beauty FAB Pharma White Clay Acne TreatmentSALICYLIC ACIDThe Procter & Gamble Manufacturing Companybeb14aca-eede-6113-e053-2a95a90a02742025-12-18WarningsExact identifier
unii: O414PZ4LPZ
First Aid Beauty FAB Acne Spot TreatmentSALICYLIC ACIDThe Procter & Gamble Manufacturing Company018e4aad-2e37-d7e9-e063-6394a90a9de22025-12-18WarningsExact identifier
unii: O414PZ4LPZ
AlcoholALCOHOLDynarex Corporation88c5dcbe-185f-4966-b98b-25d50299e8df2025-12-18WarningsExact identifier
unii: ND2M416302
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: R57ZHV85D4
unii: O414PZ4LPZ
Glentharia WART REMOVERFOR COMMON PLANTAR WARTSWART REMOVERFOR COMMON PLANTAR WARTSShenzhen Xituo Electronics Co., Ltd46223d0a-dc2f-2032-e063-6394a90a34742025-12-17WarningsExact identifier
unii: O414PZ4LPZ
clear days ahead oil-free salicylic acid acne treatment cleanserSALICYLIC ACIDPhilosophy Inc.e76dfe48-db23-47e9-8f86-640c9c7bc2a42025-12-17WarningsExact identifier
unii: O414PZ4LPZ
clear days ahead oil-free salicylic acid acne treatment and moisturizerSALICYLIC ACIDPhilosophy Inc.d7895387-100c-4cc4-9c25-0f3b9d0f59372025-12-17WarningsExact identifier
unii: O414PZ4LPZ
clear days ahead overnight repair salicylic acid acne treatment padsSALICYLIC ACIDPhilosophy Inc.741c6f90-2e32-4700-bb9f-d30329bd3dc32025-12-17WarningsExact identifier
unii: O414PZ4LPZ
clear days ahead fast-acting salicylic acid acne spot treatmentSALICYLIC ACIDPhilosophya61d0f78-9759-4085-b5e5-577d349be9fd2025-12-17WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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