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 94 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amazon basics acne blackhead clearing scrub Acne TreatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC8e129137-85c6-423d-936e-4266988506a22024-11-15WarningsExact identifier
unii: O414PZ4LPZ
Amazon Basics Acne Wash Acne treatmentSALICYLIC ACIDAMAZON.COM SERVICES LLC2e41ca5f-127a-4387-a64a-c5a4ab36192a2024-11-15WarningsExact identifier
unii: O414PZ4LPZ
e.l.f Plz Clarify Facial OilE.L.F PLZ CLARIFY FACIAL OILZhejiang Ayan Biotech Co., Ltd.25a8a0fe-d09b-3e20-e063-6394a90a51f02024-11-14WarningsExact identifier
unii: O414PZ4LPZ
amazon basics advanced blemish spot treatment Acne medicationSALICYLIC ACIDAMAZON.COM SERVICES LLC67c1ef50-ecae-46a5-924e-1cff194810502024-11-14WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena SkinClearing Mineral Powder Chestnut 135SALICYLIC ACIDKenvue Brands LLC0d1556d3-d689-c4c1-e063-6394a90adab02024-11-13WarningsExact identifier
unii: O414PZ4LPZ
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
unii: ND2M416302
Neutrogena Oil Free Acne WashSALICYLIC ACIDKenvue Brands LLC581ea73f-439a-4290-a8c0-98a25b4496dc2024-11-12WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil Free Acne Wash Pink Grapefruit Facial CleanserSALICYLIC ACIDKenvue Brands LLC2dde181f-d24f-4239-bec5-ded7fdbc98c42024-11-12WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena deep clean purifying cooling gel scrubSALICYLIC ACIDKenvue Brands LLCda2ce634-36c4-b5b7-e053-2a95a90abefb2024-11-12WarningsExact identifier
unii: O414PZ4LPZ
Cetaphil Gentle Clear Mattifying Acne MoisturizerSALICYLIC ACIDGalderma Laboratories, L.P.72977030-d9b6-435f-b321-edcbbb7315872024-11-12WarningsExact identifier
unii: O414PZ4LPZ
Hairitage Power Punch Anti-Dandruff Pre-Wash BoosterSALICYLIC ACIDMaesa, LLC.28d2ae08-e9a1-4c09-8424-1d238f97e0ae2024-11-12WarningsExact identifier
unii: O414PZ4LPZ
CVS Clarifying Body Wash Acne TreatmentSALICYLIC ACIDCVS Health058fab12-3100-4e47-8dce-7098b984b76f2024-11-12WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Oil-Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC7251bb2c-69ea-474a-8f9c-b926c31352432024-11-11WarningsExact identifier
unii: O414PZ4LPZ
Neutrogena Rapid Clear Acne Eliminating SpotSALICYLIC ACIDKenvue Brands LLC23df9335-0a7d-45bb-b35e-6d14a350d12c2024-11-11WarningsExact identifier
unii: O414PZ4LPZ
Listerine Gum Therapy Glacier MintEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLCed6889b6-58db-41cf-e053-2a95a90a7de22024-11-11WarningsExact identifier
unii: RV6J6604TK
Neutrogena Oil Free Acne Wash CleanserSALICYLIC ACIDKenvue Brands LLC6bb19e0b-042a-4e13-83c1-349844c68b612024-11-11WarningsExact identifier
unii: O414PZ4LPZ
Listerine FreshBurst AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC62b5c3ee-01cc-4c4e-9f28-e7dafa7372d82024-11-11WarningsExact identifier
unii: RV6J6604TK
Listerine Ultraclean Antiseptic Cool MintEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLCdd3729c2-fd05-4db0-a542-487bb0f9001f2024-11-11WarningsExact identifier
unii: RV6J6604TK
Listerine Cool Mint AntisepticEUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOLKenvue Brands LLC9e97e4f8-80c2-44e0-862c-0dfca392a4362024-11-11WarningsExact identifier
unii: RV6J6604TK
Noxzema ANTIBLEMISHSALICYLIC ACIDConopco Inc.69dcb600-ea59-4965-b35f-df46efcb99f82024-11-11WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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