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 104 of 118 · 2,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WART REMOVER PATCHSWART REMOVERGaozhou Chapin Technology Co., Ltd1442420a-af5f-0b21-e063-6294a90ab25d2024-03-22WarningsExact identifier
unii: O414PZ4LPZ
I.V. Prep Antiseptic WipeISOPROPYL ALCOHOLSmith & Nephew, Medical Ltd50f1c74a-bb8e-41c2-a7ee-f2d310a372a72024-03-21WarningsExact identifier
unii: ND2M416302
Lacura Blemish Dots Conceal and TreatSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.15c447b5-0e51-43e7-b697-683bc0e686c02024-03-20WarningsExact identifier
unii: O414PZ4LPZ
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c61e100b-a141-45b3-842b-855be28b02262024-03-20WarningsExact identifier
unii: O414PZ4LPZ
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f5c5a2df-11c5-4134-bf1f-b505642164492024-03-20WarningsExact identifier
unii: O414PZ4LPZ
Blemish Control Dots aloe veraSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.4722ff71-7d9f-4ef2-9f8b-3614e80b864f2024-03-20WarningsExact identifier
unii: O414PZ4LPZ
Blemish Control DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b2024-03-20WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl AlcoholISOPROPYL ALCOHOLProvision Medicalad045374-f4ad-4003-b350-8a2b0cbccb2e2024-03-14WarningsExact identifier
unii: ND2M416302
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ca0e6b50-2995-41f8-b944-9f166aac05112024-03-13WarningsExact identifier
unii: O414PZ4LPZ
Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasisSALICYLIC ACIDCardinal Health, 110 dba LEADER509434a9-50c4-4337-8e5b-17bdc667d23b2024-03-13WarningsExact identifier
unii: O414PZ4LPZ
Maximum Sterngth Cleansing Pads EquateSALICYLIC ACIDWalmart7db929b6-6470-4840-b016-7e19688548dd2024-03-11WarningsExact identifier
unii: O414PZ4LPZ
Sebex Antidandruff, anti-seborrheic dermatitis, anti-psoriasisSALICYLIC ACID, SULFURRugby Laboratoriesaec81d61-1d28-490f-9654-f66bd4a30ffa2024-03-01WarningsExact identifier
unii: O414PZ4LPZ
Rite Aid Swimmers Ear DropsISOPROPYL ALCOHOLRite Aid12875b9d-3ae8-bd0c-e063-6294a90ab4ae2024-02-29WarningsExact identifier
unii: ND2M416302
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
unii: O414PZ4LPZ
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
unii: O414PZ4LPZ
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree OilSALICYLIC ACIDRejoice International7ae434d1-8b07-4121-9163-df07598d41562024-02-28WarningsExact identifier
unii: O414PZ4LPZ
XtraCare Deep Cleaning AstringentSALICYLIC ACIDRejoice International20cb8584-8a31-40a8-8a47-d9fa8ec8abcf2024-02-28WarningsExact identifier
unii: O414PZ4LPZ
XtraCare Dandruff Hair WashSALICYLIC ACIDRejoice International1902e6bb-e829-4b1a-b85a-1394913c77ca2024-02-28WarningsExact identifier
unii: O414PZ4LPZ
The INKEY List Beta Hydroxy Acid SerumSALICYLIC ACIDBrand Evangelists for Beauty Ltdd554920f-e33a-484b-bbd8-5137156163842024-02-26WarningsExact identifier
unii: O414PZ4LPZ
LBRI PURE n NATURAL KlearAwaySALICYLIC ACIDL'BRI Health & Beauty561d17fc-0bbf-4112-9820-7d151cce00982024-02-22WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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