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 72 of 119 · 2,377 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - isopropyl alcohol liquidUNIVERSAL ISOPROPYL RUBBING ALCOHOL 70% - ISOPROPYL ALCOHOL LIQUIDTSM BRANDS LLC38d03665-6e76-c76f-e063-6294a90a9e332025-06-30WarningsExact identifier
unii: ND2M416302
Goodnites Wart Removal GelSALICYLIC ACIDZhengzhou Hangrui Network Technology Co., Ltd.3888f430-cdfe-5463-e063-6394a90a15b32025-06-27WarningsExact identifier
unii: O414PZ4LPZ
CORN REMOVER PADSSALICYLIC ACIDShenzhen Finona Information Technology Co., Ltd387460e3-5427-fc30-e063-6294a90a2ac72025-06-26WarningsExact identifier
unii: O414PZ4LPZ
Acne BusterSALICYLIC ACIDHangzhou Bo Clean Hygiene Products Co., Ltd3876df38-0085-ce8f-e063-6294a90a83ac2025-06-26WarningsExact identifier
unii: O414PZ4LPZ
Wart Remover LiquidWART REMOVER LIQUIDShenzhen Earth Surface Trading Co., Ltd.3878e867-d8ff-62f7-e063-6394a90a0d832025-06-26WarningsExact identifier
unii: O414PZ4LPZ
CeraVe Acne Clay-to-Foam CleanserSALICYLIC ACIDLOreal USA Products Inc3c4c2f52-0d37-4a3b-9a8d-2d54574b58d22025-06-26WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVER PATCHESSALICYLIC ACIDShenzhen Finona Information Technology Co., Ltd38710728-318a-a66f-e063-6294a90a017b2025-06-25WarningsExact identifier
unii: O414PZ4LPZ
Good Neighbor Pharmacy Alcohol Antiseptic Skin CleanserISOPROPYL ALCOHOLAmerisouce Bergenfc28cf11-afb9-4295-bee3-735ab10f6bbc2025-06-24WarningsExact identifier
unii: ND2M416302
Freshiny Facial Cleanser Acne TreatmentSALICYLIC ACIDGuangdong Bawei Biotechnology Corporation4afe3a7e-8119-432a-b56a-34664d9b5a122025-06-24WarningsExact identifier
unii: O414PZ4LPZ
Meret Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd.385def83-38fe-df7f-e063-6394a90abbf02025-06-24WarningsExact identifier
unii: ND2M416302
NAELI Exfoliator AHA BHA Face CleanserSALICYLIC ACIDALLI LLCe2a613c3-34f4-477e-99e6-67bcc7c117c42025-06-23WarningsExact identifier
unii: O414PZ4LPZ
El Mata CallosSALICYLIC ACIDVitamex USA, Corp21c6206e-9183-3e4f-e063-6394a90a33f72025-06-23WarningsExact identifier
unii: O414PZ4LPZ
Salicylic acidWART REMOVERRite Aid Corporation01bb867a-be7c-416b-bb00-15894d06a0292025-06-21WarningsExact identifier
unii: O414PZ4LPZ
Bangbrek Bee Venom Wart Corn Callus RemoverSALICYLIC ACID 17%Brilliance Trade LLC377946a0-0e8c-70f4-e063-6294a90a1d852025-06-20WarningsExact identifier
unii: O414PZ4LPZ
Acne Treatment CreamACNE TREATMENT CREAMGuangzhou Yapeng Refinement Chemical Co., Ltd.37fc7d7f-da18-ac40-e063-6394a90abb5d2025-06-20WarningsExact identifier
unii: O414PZ4LPZ
iBeaLee Wart RemoverIBEALEE WART REMOVERShenzhen Earth Surface Trading Co., Ltd.37e82ced-bc1e-23ba-e063-6294a90a09492025-06-19WarningsExact identifier
unii: O414PZ4LPZ
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
WISH RUBBING ALCOHOL 99%ISOPROPYL ALCOHOLLJ Pharmaa06953d7-d685-45ac-b1c6-e66dc7a05bca2025-06-18WarningsExact identifier
unii: ND2M416302
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
unii: O414PZ4LPZ
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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