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 76 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lavender Callus RemoverSALICYLIC ACID 12%SANSAR, LLC4763bab3-631a-4fcf-8387-d7df4e89e0e42025-05-09WarningsExact identifier
unii: O414PZ4LPZ
Tea Tree Oil Callus RemoverSALICYLIC ACID 12%SANSAR, LLC4acfedbf-d1af-47a9-8258-1214343830c62025-05-09WarningsExact identifier
unii: O414PZ4LPZ
Foot ScrubSALICYLIC ACID 12%SANSAR, LLCc7c93b68-e1e8-46c4-91db-095159572f412025-05-07WarningsExact identifier
unii: O414PZ4LPZ
Biome-Balancing Clear and Prevent Acne (Blemish) Treatment SerumSALICYLIC ACIDMurad, LLC3709208a-5550-4819-b923-a883878737bb2025-05-05WarningsExact identifier
unii: O414PZ4LPZ
Walgreens Corn RemoverSALICYLIC ACIDWALGREENS Co1ebfabc0-22be-468e-8a69-86b565f2773e2025-05-02WarningsExact identifier
unii: O414PZ4LPZ
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHHUZHOU JUNDA INDUSTRY CO., LTD.367ab42b-46fe-90f7-e063-6394a90ad2032025-05-01WarningsExact identifier
unii: ND2M416302
AntiDandruffShampoo365 ANTI DANDRUFF SHAMPOOWhole Foods Market, Inc.b9bc6bbb-31c5-427e-e053-2995a90a5f172025-04-29WarningsExact identifier
unii: O414PZ4LPZ
AntiDandruffShampooConditioner365 ANTI DANDRUFF SHAMPOO CONDITIONER 2 IN 1Whole Foods Market, Inc.c3f5b5fb-acb0-a904-e053-2995a90a56232025-04-29WarningsExact identifier
unii: O414PZ4LPZ
MY BEAUTY SPOT Day and Night Acne PatchSALICYLIC ACIDMELON BIO-TECH (THAILAND) CO., LTD.6e4ab3d3-378e-40e5-a6a5-66090edcfda82025-04-28WarningsExact identifier
unii: O414PZ4LPZ
UTTSE Anti Fungal Shampoo.ANTI FUNGAL SHAMPOOShenzhen Xinxin Yunhai Technology Co., Ltd.33bebbe9-e0ab-2f7d-e063-6294a90add4e2025-04-27WarningsExact identifier
unii: O414PZ4LPZ
Germ Attack 70% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375d44e-5af6-8c7f-e063-6394a90abb4b2025-04-25WarningsExact identifier
unii: ND2M416302
Germ Attack 91% Isopropyl AlcoholISOPROPYL ALCOHOLNatural Essentials, Inc.3375e0d7-07fa-6489-e063-6294a90a91ec2025-04-25WarningsExact identifier
unii: ND2M416302
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
unii: ND2M416302
Byoma Acne Control BodySALICYLIC ACIDByoma Ltd2ffedd29-b05d-485c-e063-6294a90a382b2025-04-23WarningsExact identifier
unii: O414PZ4LPZ
Byoma Acne Control MoisturizerSALICYLIC ACIDByoma Ltd300266fa-81fb-c26a-e063-6394a90abedf2025-04-23WarningsExact identifier
unii: O414PZ4LPZ
Byoma Acne Treatment SpotSALICYLIC ACIDByoma Ltd301673da-7202-49cf-e063-6294a90a520e2025-04-23WarningsExact identifier
unii: O414PZ4LPZ
Byoma Acne Clearing CleanserSALICYLIC ACIDByoma Ltd30036070-f5f1-c082-e063-6294a90a66e12025-04-23WarningsExact identifier
unii: O414PZ4LPZ
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
unii: ND2M416302
OSNOIA Wart RemoverWART REMOVERGuangzhou Zanming Trading Co., Ltd.3358ffb7-09e8-b3d7-e063-6394a90a5e432025-04-22WarningsExact identifier
unii: O414PZ4LPZ
Listerine Clinical Solutions Gum Health Icy MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC06e1122b-1100-43c0-e063-6394a90a2e782025-04-22WarningsExact identifier
unii: RV6J6604TK

Reported adverse events (FAERS/openFDA)#

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