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 23 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Personal Day Doing the Work Daily Exfoliating TreatmentSALICYLIC ACIDPersonal Day Inc.af9b8b32-b58b-4988-bbf1-2257eaaa9d262026-04-30WarningsExact identifier
unii: O414PZ4LPZ
Wart RemoverSALICYLIC ACIDCVS Pharmacy4dcccf04-5c4f-1202-e063-6394a90ab9d82026-04-30WarningsExact identifier
unii: O414PZ4LPZ
MINADCIN WART REMOVER PATCHESSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD50aaae3a-26b3-49e5-e063-6394a90ae5fc2026-04-30WarningsExact identifier
unii: O414PZ4LPZ
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Salicylic AcidWART REMOVER LIQUIDCVS Pharmacy90bc4d32-f865-4e33-86a0-4b860b610fa82026-04-30WarningsExact identifier
unii: O414PZ4LPZ
Walgreens Pink Grapefruit Acne WashSALICYLIC ACIDWALGREEN COMPANY30cdd09b-10ee-f3a8-e063-6294a90ab77b2026-04-30WarningsExact identifier
unii: O414PZ4LPZ
Acne DryingSALICYLIC ACIDSpa de Soleilcc0e788a-583c-8414-e053-2995a90a2cb72026-04-30WarningsExact identifier
unii: O414PZ4LPZ
Acne Treatment PadsSALICYLIC ACIDSpa de Soleilcc0f8f77-1942-22be-e053-2a95a90a3d7f2026-04-30WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLWalmart Inc.1fd3d29f-7da0-c5ba-e063-6294a90add162026-04-29Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Salicylic Acid 0.5% Body SerumSALICYLIC ACIDDeciem5036dc50-e95c-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
unii: O414PZ4LPZ
SALICYLIC ACIDSALICYLIC ACIDAcella Pharmaceuticals, LLC572171f7-832f-4710-b888-eef5638fc9d42026-04-24Adverse reactionsExact identifier
unii: O414PZ4LPZ
Wart removerSALICYLIC ACIDDr.Ramay Beauty Science Inc502ca820-2f62-dfda-e063-6394a90a35572026-04-23WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Folliculitis .shampoo.SELENIUMDISULFIDE 1%CAVTECH HOLDING LLC502caa29-f817-cc12-e063-6394a90a22402026-04-23WarningsExact identifier
unii: O414PZ4LPZ
3M DuraPrep SurgicalIODINE POVACRYLEX AND ISOPROPYL ALCOHOLSolventum US LLC22a10a54-6a04-48b3-9ec4-b26526183daf2026-04-23WarningsExact identifier
unii: ND2M416302
3M SoluPrep SCHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOLSolventum US LLC084aa305-5863-441a-a94d-36bc1b05195a2026-04-23WarningsExact identifier
unii: ND2M416302
Zitsticka Killa Acne Extra StrengthSALICYLIC ACIDBrndxl LLC463db517-be07-8c90-e063-6394a90a4c8c2026-04-22WarningsExact identifier
unii: O414PZ4LPZ
ZO Skin Health Oil Control Pads Acne TreatmentSALICYLIC ACIDZO Skin Health, Inc.84283a64-8f31-4e98-ad04-948dbe94887d2026-04-22WarningsExact identifier
unii: O414PZ4LPZ
BHA TONERSALICYLIC ACIDDrmtlgy, LLC74010a22-9a3d-4372-9fb3-c660578e675a2026-04-22WarningsExact identifier
unii: O414PZ4LPZ
dasWagen Skin Tag Remover Wart Remover LiquidDASWAGEN SKIN TAG REMOVER WART REMOVER LIQUIDGuangzhou ChuanMa International Trading Co.,Ltd.4ffd28c1-af28-bc1b-e063-6294a90ab2c12026-04-21WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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