FDA.reportPublic FDA data

NDC 46521-007 - Bio-Groom Ear-Care Ear Cleaner

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
46521-007
Package NDCs from labels
46521-007-25
Manufacturer
Bio-Derm Laboratories Inc.
Effective date
2011-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bio-Groom Ear-Care Ear Cleaner PadsBio-Derm Laboratories Inc.2011-07-13OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46521-007-25Bio-Groom Ear-Care Ear Cleaner25 in 1 JARSOLUTION252

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46521-007BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]21 package rows20110803_bfc4868a-0ab2-4abd-afa3-a470feb65d76.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.]2
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
BORIC ACIDACTIVE MOIETYR57ZHV85D4BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TKBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302BIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RBIO-GROOM (BORIC ACID AND SALICYLIC ACID) SOLUTION [BIO-DERM LABORATORIES INC.]2

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 34 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Companya631c976-cb9b-4099-8630-2a10c14bd3bd2026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
unii: ND2M416302
Medicated Apricot ScrubSALICYLIC ACIDUnited Natural Foods, Inc. dba UNFI677c19eb-780b-479b-ab1d-df249e0af6ea2026-02-16Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLUnited Natural Foods, Inc. dba UNFIcce74940-ebf1-4fa4-9ef4-50619704d5cd2026-02-16Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
PoreFectSALICYLIC ACIDOur-Science Inc.4afe4115-cdf0-6dd3-e063-6394a90a24532026-02-16WarningsExact identifier
unii: O414PZ4LPZ
Tuymec Anti-Dandruff Shampoo.ANTI-DANDRUFF SHAMPOO.Guangzhou Jingliang Cosmetics Co., Ltd.4ae93408-5c8f-c0a5-e063-6394a90a9e0d2026-02-15WarningsExact identifier
unii: O414PZ4LPZ
RoyceDerm Seborrheic Dermatitis and Psoriasis Treatment creamSALICYLIC ACID 3%RoyceDerm LLC4ac42528-9210-6936-e063-6294a90a41682026-02-14WarningsExact identifier
unii: O414PZ4LPZ
Antiseptic Mouth RinseEUCALYPTOL, MENTHOL, METHYOL SALICYLATE, THYMOLTopco Associates LLCa38e91c1-7ac6-4a7f-a5a2-8d9166b1535a2026-02-13Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Original AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCb6c8d5b1-4b19-463c-826a-cccdcec09e2d2026-02-13Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC24b19a98-143d-4634-b2b3-4d02dfd579872026-02-13Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLCa1915524-2719-40d4-86e3-35df5ce3238d2026-02-13Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLTopco Associates LLC0d97cb54-1b9c-4aff-a15c-3bf9b66782092026-02-13Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
unii: O414PZ4LPZ
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact identifier
unii: O414PZ4LPZ
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWinCo Foods, LLC2022986a-2a93-4291-887c-c23f2b2c83a72026-02-12Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK

Reported adverse events (FAERS/openFDA)#

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