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 19 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
unii: O414PZ4LPZ
Compound WSALICYLIC ACID GELASO LLCb55c7421-a8fe-8d4e-e053-2a95a90a7a6f2026-05-27WarningsExact identifier
unii: O414PZ4LPZ
Gel Corn RemoverSALICYLIC ACIDHEB52d0c9e5-b943-7459-e063-6294a90a35f22026-05-27WarningsExact identifier
unii: O414PZ4LPZ
Medicated Callus RemoversSALICYLIC ACIDPremier Brands of America Inc52d0b36c-b65e-00cf-e063-6294a90ad0892026-05-27WarningsExact identifier
unii: O414PZ4LPZ
KUGIG ACNE TREATMENT SPRAYERSALICYLIC ACIDGuangdong Jiaoyu Biotechnology Co., Ltd.52b1e9cb-c083-a6eb-e063-6294a90ab6d12026-05-26WarningsExact identifier
unii: O414PZ4LPZ
MyMedic Sting Relief WipeBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd52b5653e-289c-d99e-e063-6294a90aa6472026-05-26WarningsExact identifier
unii: ND2M416302
KTLEPOWER WART REMOVER FOR COMMON PLANTAR WARTSWART REMOVER FOR COMMON PLANTAR WARTSShenzhen Xituo Electronics Co., Ltd529f72ba-f5d4-c5ce-e063-6294a90a01be2026-05-25WarningsExact identifier
unii: O414PZ4LPZ
PIOSMZSE WART REMOVER FOR COMMON PLANTAR WARTSWART REMOVER FOR COMMON PLANTAR WARTSShenzhen Xituo Electronics Co., Ltd52a03a15-58e7-6092-e063-6294a90a72272026-05-25WarningsExact identifier
unii: O414PZ4LPZ
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.201eeecd-e759-42b8-b5c2-b19465d983322026-05-25WarningsExact identifier
unii: O414PZ4LPZ
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%MELON BIO-TECH (THAILAND) CO., LTD.a5431ecd-0afc-4525-9157-ee05ff752df52026-05-25WarningsExact identifier
unii: O414PZ4LPZ
Swab Applicator Brushes 8.3% w/w Povidone-Iodine and 72.5% w/w Isopropyl Alcohol (IPA)POVIDONE-IODINE, ISOPROPYL ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD529b8ad6-081e-0ef8-e063-6294a90a67df2026-05-24WarningsExact identifier
unii: ND2M416302
XEXLVOV MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd529bf32f-b40b-9602-e063-6294a90a1c2a2026-05-24WarningsExact identifier
unii: O414PZ4LPZ
Swab Stick 2% w/w chlorhexidine gluconate (CHG) and 70% v/v isopropyI alcohol (IPA)CHLORHEXIDINE GLUCONATE, ISOPROPYI ALCOHOLXINXIANG XINDA TECHNOLOGY CO.,LTD51c42761-3a7a-172d-e063-6394a90a53332026-05-24WarningsExact identifier
unii: ND2M416302
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ea66728a-bfb8-4313-b308-fa54306859f72026-05-22WarningsExact identifier
unii: O414PZ4LPZ
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.51024d71-07ab-49d5-8c60-058388a5df0e2026-05-22WarningsExact identifier
unii: O414PZ4LPZ
TOTCLEAR Genital Wart RemoverSALICYLIC ACIDGOOD BRIDGE LLC5828be93-649c-45a1-8507-985e51cdb1f22026-05-22WarningsExact identifier
unii: O414PZ4LPZ
TOTCLEAR Wart and Spot EraserSALICYLIC ACIDGOOD BRIDGE LLCf21e7f0b-b8d6-43b1-9a80-37da5e29bf932026-05-22WarningsExact identifier
unii: O414PZ4LPZ
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr.Johnes Liquid Skin Wart Corn RemoverSALICYLIC ACIDDr.Johnes LLCf9efe02a-abc9-4a2f-afb0-9d358fc35c912026-05-22WarningsExact identifier
unii: O414PZ4LPZ
Walgreens 70% Isopropyl Alcohol WipesISOPROPYL ALCOHOLWalgreen Companye8b0ecc3-3a30-47c9-b7d1-518681d575b42026-05-21WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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