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 12 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7 Day Spot and Tag Remover PenSALICYLIC ACIDGuangxi Keyun E-commerce Co., Ltd.5675f3cb-6b8f-2ba2-e063-6294a90a3fd62026-07-12WarningsExact identifier
unii: O414PZ4LPZ
NATURAL CURES WART REMOVERSALICYLIC ACID 17% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.5650ed83-2572-083b-e063-6294a90a5d692026-07-11WarningsExact identifier
unii: O414PZ4LPZ
THRYLIA TAG WART REMOVERSALICYLIC ACID 17% TAG WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.56536544-3a0b-36e3-e063-6394a90adf7b2026-07-11WarningsExact identifier
unii: O414PZ4LPZ
SKINARIS TAG WART REMOVERSALICYLIC ACID 17% TAG WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.56536aab-0a60-16fa-e063-6294a90a39132026-07-11WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Psoriasis Shampoo.SALICYLIC ACID 3%CAVTECH HOLDING LLC563e75f9-a1e2-2796-e063-6294a90aedb42026-07-10WarningsExact identifier
unii: O414PZ4LPZ
Alcohol Cleansing WipeISOPROPYL ALCOHOLHubei Fanjian Medical Product Co.,Ltd1607fb06-826b-42bb-986e-0023a1b078f32026-07-10WarningsExact identifier
unii: ND2M416302
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
unii: O414PZ4LPZ
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
unii: O414PZ4LPZ
Wart RemoverSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.562a0178-1653-df26-e063-6394a90aa37f2026-07-09WarningsExact identifier
unii: O414PZ4LPZ
Gembooxt Vaginal Probiotics GelCOPTIS CHINENSIS ROOTGuangdong Quadrant Ecological Technology Co., Ltd.464b0e4a-6d92-9a03-e063-6294a90a6ff42026-07-09WarningsExact identifier
unii: R57ZHV85D4
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
unii: O414PZ4LPZ
Wart RemoverSALICYLIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.5639b6ef-f7e5-df27-e063-6394a90ad4562026-07-09WarningsExact identifier
unii: O414PZ4LPZ
Dr.Johnes Liquid Skin Wart Corn Remover 40% Salicylic AcidSALICYLIC ACIDDr.Johnes LLCa76d32cc-aa48-408c-bf9e-b517bb1ac5242026-07-08WarningsExact identifier
unii: O414PZ4LPZ
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: ND2M416302
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
unii: O414PZ4LPZ
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
unii: ND2M416302
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
unii: O414PZ4LPZ
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact identifier
unii: O414PZ4LPZ
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
LadovernaSALICYLIC ACID SOLUTIONGuangzhou Oupeng Cosmetics Co., Ltd.55ea1515-b4f1-5d7d-e063-6394a90ab7bc2026-07-05WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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