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 78 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
unii: ND2M416302
MouthwashMENTHOL, METHYL SALICYLATE, THYMOLOrazen Inc873c43df-1d46-359b-e053-2a91aa0a43192025-04-07WarningsExact identifier
unii: RV6J6604TK
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.31ee4645-0f64-f7a0-e063-6394a90a17362025-04-04WarningsExact identifier
unii: O414PZ4LPZ
LEAHUE MADHUCASALICYLIC ACIDBio-interchange Co.81470dfe-f063-9d16-e053-2a91aa0a18292025-04-04WarningsExact identifier
unii: O414PZ4LPZ
AHA BHA Blemish Control and Exfoliating SerumSALICYLIC ACID SERUMBanuskin, Inc.31e47495-a9fa-a9e8-e063-6294a90a6b672025-04-03WarningsExact identifier
unii: O414PZ4LPZ
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Kenkoderm Psoriasis MoisturizingSALICYLIC ACIDNexgel,Inc.31ce20a2-95ae-e424-e063-6394a90af18a2025-04-01WarningsExact identifier
unii: O414PZ4LPZ
Kenkoderm PsoriasisSALICYLIC ACIDNexgel,Inc.31cf90e5-0f21-903d-e063-6394a90a075d2025-04-01WarningsExact identifier
unii: O414PZ4LPZ
Shea MoistureNOURISHED AND RADIANT ACNE TREATMENT SERUM WITH 2% SALICYLIC ACIDConopco d/b/a/ Unilever31815039-5685-6b05-e063-6294a90a2a5e2025-03-29WarningsExact identifier
unii: O414PZ4LPZ
Listarfe Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOOGuangzhou Zanming Trading Co., Ltd.3163eee0-379f-1f88-e063-6294a90a58ce2025-03-28WarningsExact identifier
unii: O414PZ4LPZ
Clarifying CleanserSALICYLIC ACIDMurad, LLC9c9e66fb-9212-4e61-b7ba-c31cfa91d3c92025-03-28WarningsExact identifier
unii: O414PZ4LPZ
CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing TechnologySALICYLIC ACIDL'Oreal USA Products Inc7b622b57-21be-4870-a2fe-11447a9e321a2025-03-28WarningsExact identifier
unii: O414PZ4LPZ
Clarifying CleanserSALICYLIC ACIDMurad, LLC8297fbbe-ea3f-40bc-8dd8-319de45b30242025-03-28WarningsExact identifier
unii: O414PZ4LPZ
Kiehls Gently Effective Acne Treating CleansingSALICYLIC ACIDL'Oreal USA Products Incb6894aae-c131-4e4a-a035-f7c20f6bc5052025-03-28WarningsExact identifier
unii: O414PZ4LPZ
TKTXTKTXCOMMERCE OPERATIONS LLC2f867e2b-df7d-c34a-e063-6294a90a17242025-03-25WarningsExact identifier
unii: O414PZ4LPZ
MQUPIN Corn Removal PadsCORN REMOVAL PADSZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09769ae3-d19d-e2dd-e063-6294a90a1f642025-03-24WarningsExact identifier
unii: O414PZ4LPZ
MYMULIKE Corn Removal PadsCORN REMOVAL PADSZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09777a9d-2dd1-4f87-e063-6294a90ac1392025-03-24WarningsExact identifier
unii: O414PZ4LPZ
Scalp RevivalSALICYLIC ACID 3%Beccair, LLC0a77e90e-a33a-43f3-80a0-a16a6902a7352025-03-21WarningsExact identifier
unii: O414PZ4LPZ
SaniiswabISOPROPYL ALCOHOLPOLLEY MED LLC303b1ad5-a104-3479-e063-6294a90abcde2025-03-20WarningsExact identifier
unii: ND2M416302
Neutrogena Body Clear Body ScrubSALICYLIC ACIDKenvue Brands LLC8dbd1942-f644-446b-9292-8fc44fb165a22025-03-20WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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