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 24 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aemerry WART, CORN AND CALLUS REMOVERSALICYLIC ACID 1.5%Da Capo Prima LLC4fdf07ef-cd43-6d75-e063-6394a90a8d712026-04-20WarningsExact identifier
unii: O414PZ4LPZ
dasWagen Skin Tag Remover Wart Remover CreamDASWAGEN SKIN TAG REMOVER WART REMOVER CREAMGuangzhou ChuanMa International Trading Co.,Ltd.4fe8d1cd-7d05-6b6c-e063-6294a90a0c972026-04-20WarningsExact identifier
unii: O414PZ4LPZ
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)9f991292-bbaa-4f4e-b2cb-059d1a04849e2026-04-20WarningsExact identifier
unii: RV6J6604TK
Skin Wart Remover LiquidSKIN WART REMOVER LIQUIDShenzhen Earth Surface Trading Co., Ltd.4fdc0690-37fb-4254-e063-6294a90a0ec02026-04-19WarningsExact identifier
unii: O414PZ4LPZ
Megababe Chesto Presto Acne MistSALICYLIC ACIDMEGABABE, LLC414cccb5-194d-133c-e063-6394a90a6af02026-04-17WarningsExact identifier
unii: O414PZ4LPZ
Genital wart removal onitmentSALICYLIC ACID 40%Guangxi Keyun E-commerce Co., Ltd.4f8f0131-ed5f-027d-e063-6294a90a276c2026-04-16WarningsExact identifier
unii: O414PZ4LPZ
AmazingLink Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4f910340-d3bc-ef99-e063-6294a90ac9c22026-04-16WarningsExact identifier
unii: O414PZ4LPZ
Tartar control plusEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLH E Be425bc4c-88c7-48ec-98ef-46b45436a6892026-04-16Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
SAMPICK WART REMOVER PATCHESSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4f7b6a6a-43de-9aea-e063-6294a90a50a42026-04-15WarningsExact identifier
unii: O414PZ4LPZ
KEEP IT CLEAR ACNE FOAM CLEANSERKEEP IT CLEAR ACNE FOAM CLEANSERPML NYC, LLCea9442a4-f9f1-4f7c-e053-2a95a90a74432026-04-15WarningsExact identifier
unii: O414PZ4LPZ
ALCOHOL PREP PADS LARGE STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD4f8ba6c8-5155-c491-e063-6394a90adde92026-04-15WarningsExact identifier
unii: ND2M416302
CIDUAM Wart Corn RemoverWART CORN REMOVERShenzhen TeLaFaErJiaLuo Technology Co., Ltd.4f2b57db-9704-83e2-e063-6394a90a52592026-04-14WarningsExact identifier
unii: O414PZ4LPZ
ProBliva Psoriasis Scalp .spray.SALICYLIC ACID 3%CAVTECH HOLDING LLC4f695604-51c5-c1b7-e063-6294a90ab5ae2026-04-14WarningsExact identifier
unii: O414PZ4LPZ
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic AcidSALICYLIC ACIDAnna Lotan Ltd.2b57da0c-889b-41c3-9aca-c60ef49b76032026-04-14WarningsExact identifier
unii: O414PZ4LPZ
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPublix Super Markets, Inc.04eb6dfd-bdb7-46f3-930e-9c900fdd0b5b2026-04-14Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Original AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPublix Super Markets, Inc.6695a3fb-b6c2-4752-a86f-d021fb5584582026-04-14Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLPublix Super Markets, Inc.1046b6b5-b439-4d32-87b3-c118a58bf1912026-04-14Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Aiilo WART REMOVER PATCHESSALICYLIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.4f53b7ac-adda-b815-e063-6294a90ad9332026-04-13WarningsExact identifier
unii: O414PZ4LPZ
SootheSense Wart Remover LiquidSALICYLIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca4361c-3c9a-e095-e063-6394a90ac4562026-04-10WarningsExact identifier
unii: O414PZ4LPZ
Aiilo WART REMOVERSALICYLIC ACID 25%Guangzhou Huixue Biotechnology Co., Ltd.4f17d170-a203-b8f3-e063-6294a90a09802026-04-10WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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