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 74 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena T/Sal TherapeuticSALICYLIC ACIDKenvue Brands LLC54707f0f-6025-4dc3-8be8-7a38bb1363b82025-06-05WarningsExact identifier
unii: O414PZ4LPZ
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONbc9fffbc-c176-4d89-b1c6-294a8439a9302025-06-05WarningsExact identifier
unii: O414PZ4LPZ
The Pharma-C Company 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLKleen Test Products Corporationa0f93dac-7baa-4f79-b6a0-3cabe52806bb2025-06-04WarningsExact identifier
unii: ND2M416302
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDPRODUCTOS CAPILARES L'OREAL SAaae04d08-9d0c-43bd-89c2-741884de3bea2025-06-04WarningsExact identifier
unii: O414PZ4LPZ
Vichy Laboratoires Dercos Salicylic Acid Antidandruff Water to FoamSALICYLIC ACIDL'Oreal USA Products Incbcffd505-82bd-45ce-9ad0-64a9e63f62b52025-06-04WarningsExact identifier
unii: O414PZ4LPZ
MEOLY Skin Tag RemoverSKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.36a72a43-fdbf-fcc1-e063-6394a90a4dc82025-06-03WarningsExact identifier
unii: O414PZ4LPZ
TULA SKINCARE BREAKOUT BREAKTHROUGH ACNE TONER PADSSALICYLIC ACIDThe Procter & Gamble Manufacturing Company36ada73d-cfc5-d4a4-e063-6294a90a7c732025-06-03WarningsExact identifier
unii: O414PZ4LPZ
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.4058327e-2764-4df0-9d5d-7cda72d9ca412025-06-02WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd3640d29e-7e4c-b3be-e063-6394a90a0d9e2025-05-29WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC36412939-97bc-6cb1-e063-6294a90aef482025-05-29WarningsExact identifier
unii: O414PZ4LPZ
Tula Skincare Clear It Up Acne Clearing and Tone Correcting GelSALICYLIC ACIDThe Procter & Gamble Manufacturing Company364a96fb-67fe-eeb7-e063-6394a90aa60c2025-05-29WarningsExact identifier
unii: O414PZ4LPZ
DermaD ANTI-ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.8f4a57cb-0a5b-42b0-a325-1f92f3942ad92025-05-29WarningsExact identifier
unii: O414PZ4LPZ
DermaD ATOPIC DERMATITIS TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.d872a4ee-554e-4bca-acb1-3bbf57dc690b2025-05-29WarningsExact identifier
unii: O414PZ4LPZ
DermaD JOCK ITCH TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.c8c0449c-11f9-4434-a91c-b690d67808202025-05-29WarningsExact identifier
unii: O414PZ4LPZ
DermaD ANTIFUNGAL TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.b97684ae-79d0-4208-b480-67794596ece72025-05-29WarningsExact identifier
unii: O414PZ4LPZ
Psoriasis Scalp TreatmentSALICYLIC ACIDRida LLC14ab77e7-86b0-49d3-8efa-8a80c5a24d742025-05-28WarningsExact identifier
unii: O414PZ4LPZ
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.361dcd60-c194-4c8b-e063-6294a90a425b2025-05-27WarningsExact identifier
unii: ND2M416302
Toenail Fungus LiquidTOENAIL FUNGUS LIQUIDShenzhen Earth Surface Trading Co., Ltd.361f4c5c-7fa7-0440-e063-6294a90aad9f2025-05-27WarningsExact identifier
unii: RV6J6604TK
HCS Alcohol Prep Pad LargeISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC.2cbe0c4c-440d-4f6c-88e8-363d3c798fba2025-05-27WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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