FDA.reportPublic FDA data

NDC 46521-003-04 - 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
Requested NDC
46521-003-04
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 1 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SOLUMIRA WART REMOVER CreamSALICYLIC ACID 17% WART REMOVER CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5d374c1e-0a16-df23-e063-6294a90ad9df2026-10-06WarningsExact identifier
unii: O414PZ4LPZ
Wart Remover LiquidWART REMOVER LIQUIDShenzhen Earth Surface Trading Co., Ltd.3878d5a4-8b78-5aec-e063-6294a90ace572026-09-27WarningsExact identifier
unii: O414PZ4LPZ
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: RV6J6604TK
Dcsily Liquid Wart Corn RemoverLIQUID WART CORN REMOVERShenzhen Xinxin Yunhai Technology Co., Ltd.5b1bf2f7-422f-8713-e063-6394a90adee32026-09-10WarningsExact identifier
unii: O414PZ4LPZ
OJIOG WART REMOVER CreamSALICYLIC ACID 40% WART REMOVER CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5b1cff55-0478-62d2-e063-6394a90abfc72026-09-10WarningsExact identifier
unii: O414PZ4LPZ
Defense Acne Care 2% Salicylic AcidSALICYLIC ACID 2%Defense Soap LLC98fcc243-d789-181d-e053-2995a90a9b5d2026-09-09WarningsExact identifier
unii: O414PZ4LPZ
Wart RemoverGLYCERINShantou Ouhoe Technology Co., Ltd.5af3afe1-dad5-91b7-e063-6294a90ab95e2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Saviland PRO Core-Clearing Maximum Strength Corn and Callus PadsSALICYLIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5af3cffb-7355-b2ce-e063-6394a90a85112026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Alcohol Prep Pad MediumALCOHOL PREP PADYangzhou Huanrui Medical Technology Co., Ltd5af3eedc-d01e-c9e9-e063-6394a90a49e12026-09-08WarningsExact identifier
unii: ND2M416302
TepidSun WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5a181d19-86e2-97b1-e063-6394a90a19f12026-09-08WarningsExact identifier
unii: O414PZ4LPZ
TRLYC WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.59b4d4a2-f7c5-a73a-e063-6294a90ae8c02026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Aiilo WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58ad9307-a9f9-4de8-e063-6394a90adaa62026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Aiilo WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58af5ac2-75a7-246d-e063-6394a90ae9662026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-09-08WarningsExact identifier
unii: O414PZ4LPZ
GPPEE WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5715c122-8ba8-6f1e-e063-6294a90a805f2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
DVO WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57028c23-e012-9066-e063-6394a90a910b2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.56e118b3-c27f-c14a-e063-6394a90ab75e2026-09-08WarningsExact identifier
unii: O414PZ4LPZ
GPPEE WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.568a84eb-c0f7-6ce6-e063-6294a90a15b42026-09-08WarningsExact identifier
unii: O414PZ4LPZ
OMPLEN WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.5652eb70-23f2-91cb-e063-6294a90a11962026-09-08WarningsExact identifier
unii: O414PZ4LPZ
Jorvinl WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.55c66a49-9d89-84a2-e063-6294a90a114e2026-09-08WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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