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 47 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD29269551-5610-2c5c-e063-6294a90a8a7e2026-01-08WarningsExact identifier
unii: ND2M416302
RoyceDerm Anti fungal RELIEF creamSALICYLIC ACID 2%RoyceDerm LLC47ec6277-e40f-af82-e063-6294a90ac8c12026-01-08WarningsExact identifier
unii: O414PZ4LPZ
Bacterial Immune Stimulator 6006BACTERIAL IMMUNE STIMULATORProfessional Complementary Health Formulas22f3b809-c294-4319-aed9-632f34608cbb2026-01-08WarningsExact identifier
unii: RV6J6604TK
Fire Retardant Chemical Detox 6041FIRE RETARDANT CHEMICAL DETOXProfessional Complementary Health Formulase85b0277-11a0-44f6-9945-155f8adec9542026-01-08WarningsExact identifier
unii: R57ZHV85D4
Proactiv Clean Acne Clearing HydratorSALICYLIC ACIDAlchemee, LLC33ac397c-55af-4a50-b5ce-80f8a88015812026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv CLEAR ZONE BODY PADSSALICYLIC ACIDAlchemee, LLCcf9e5536-08f6-4bbd-9e09-2e9a0c768ed92026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Plus Complexion Perfecting HydratorSALICYLIC ACIDAlchemee, LLCc9b91b61-738e-474e-927f-0806264c739e2026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Plus Retexturizing TonerSALICYLIC ACIDAlchemee, LLC7c211ff7-920f-407b-ad8d-60d14803b8572026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Clarifying NightSALICYLIC ACIDAlchemee, LLC8b81b4e5-f2fc-45a1-923a-7c326529d68b2026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Deep Cleansing WashSALICYLIC ACIDTHE PROACTIV COMPANY LLC4a2bd12d-f166-43cf-b175-d20affc805262026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Advanced Daily Oil ControlSALICYLIC ACIDAlchemee, LLC945be4e4-1ca2-41df-b3c8-da7b8fe38bc42026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Blackhead DissolvingSALICYLIC ACIDAlchemee, LLC822c64b9-59bd-4625-b4bf-294d54c96e102026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactivplus Smoothing BHA CleanserSALICYLIC ACIDAlchemee, LLC14b9a54c-9993-385e-e063-6394a90a27de2026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Blemish Control Body CreamSALICYLIC ACIDAlchemee, LLC164d2c7f-5f1e-d0a8-e063-6294a90a95f22026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Redness Correcting TreatmentSALICYLIC ACIDAlchemee, LLC25ca582d-158f-2c97-e063-6394a90a56582026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Proactiv Acne Clearing BodySALICYLIC ACIDAlchemee, LLC22559e3a-3ca4-fb38-e063-6394a90ada9e2026-01-07WarningsExact identifier
unii: O414PZ4LPZ
Universal Clarifying PadSALICYLIC ACIDAllure Labs47d3c57c-d6d2-a9e0-e063-6294a90a3b5b2026-01-07WarningsExact identifier
unii: O414PZ4LPZ
WART CORN Liquid REMOVER MaskSALICYLIC ACIDGuangdong Joyan Biological Technology Co.,Ltd3e7e9d92-ae11-898d-e063-6394a90a21d72026-01-06WarningsExact identifier
unii: O414PZ4LPZ
BenzocaineBENZOCAINEDynarex Corporation6161e94c-7849-466e-8da3-a6f1b085bdf92026-01-06WarningsExact identifier
unii: ND2M416302
Multi Food AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), ALLIUM CEPA, ALLIUM SATIVUM, ALMOND, APIUM GRAVEOLENS, BETA VULGARIS, BRASSICA OLERACEA VAR. ITALICA, BRAZIL, CACAO, CAPSICUM ANNUUM, CASHEW, CICER ARIETINUM, CITRUS LIMONUM, COCONUT, COFFEA TOSTA, COLLAGEN, CORN, CUCUMIS SATIVUS, ENGLISH WALNUT, GLYCINE MAX, HEART (BOVINE), HEART (SUIS), LAC VACCINUM, LACTUCA SATIVA, LYCOPERSICUM ESCULENTUM, ORANGE, OXALICUM ACIDUM, PEANUT, PECAN, PHASEOLUS, PHASEOLUS VULGARIS, RAPHANUS SATIVUS, SESAME,Energique, Inc.a289e8a7-1188-43be-b34b-fe6d5ee09d1c2026-01-06WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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