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 5 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne ReliefSALICYLIC ACID,NIACINAMIDE,PANTHENOL.Guangzhou Senmai Biotechnology Co.,Ltd.59db0143-de57-59d2-e063-6294a90a32a82026-08-25WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVER PATCHSSALICYLIC ACID 17%Guangxi Keyun E-commerce Co., Ltd.572b71cc-6af0-4a49-e063-6394a90afed22026-08-25WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVERSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.59df0688-5d06-1da4-e063-6394a90a799b2026-08-25WarningsExact identifier
unii: O414PZ4LPZ
Curad Alcohol Sterile, ThickISOPROPYL ALCOHOLMedline Industries, LPb769898e-a73f-4323-af15-bee8dbe455b62026-08-25WarningsExact identifier
unii: ND2M416302
Salicylic Acid Acne Gel CleanserSALICYLIC ACID,PANTHENOLGuangzhou Senmai Biotechnology Co.,Ltd.59eb395b-493b-efc9-e063-6294a90aa8912026-08-25WarningsExact identifier
unii: O414PZ4LPZ
TOTCLEAR SKIN WART CORN REMOVERSALICYLIC ACIDGOOD BRIDGE LLC4270e1c0-5a8a-40b6-b93e-2f95e70e34eb2026-08-25WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVERSALICYLIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.59c32b2b-5be0-74a8-e063-6394a90ab71f2026-08-24WarningsExact identifier
unii: O414PZ4LPZ
WART REMOVERSALICYLIC ACIDYantai Dupont Daily Necessities Co., Ltd.59c6e6f4-0393-8df1-e063-6394a90a16572026-08-24WarningsExact identifier
unii: O414PZ4LPZ
OJIOG WART REMOVER LiquidSALICYLIC ACID 40% WART REMOVER LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.59c87257-1ea7-c2fb-e063-6294a90a376f2026-08-24WarningsExact identifier
unii: O414PZ4LPZ
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Salicylic Acid Body WashSALICYLIC ACIDGuangdong Danlan International Biotechnology Co., Ltd59d671e7-7bbc-a963-e063-6394a90a776f2026-08-24WarningsExact identifier
unii: O414PZ4LPZ
SAMPICK WART REMOVER PatchesSALICYLIC ACID 40% WART REMOVER PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.59d6b84e-ede5-20d6-e063-6394a90a226c2026-08-24WarningsExact identifier
unii: O414PZ4LPZ
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
unii: O414PZ4LPZ
Tikuns WART REMOVER PatchesSALICYLIC ACID 40% WART REMOVER PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.599ed83a-e310-861e-e063-6394a90a3c962026-08-22WarningsExact identifier
unii: O414PZ4LPZ
BEE VENOM WART CORN WART REMOVERSALICYLIC ACID BEE VENOMGuangzhou ChuanMa International Trading Co.,Ltd.59a14998-927f-6475-e063-6294a90a7f522026-08-22WarningsExact identifier
unii: O414PZ4LPZ
AIADR Liquid WART CORN REMOVERSALICYLIC ACID 17% LIQUID WART CORN REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.598a9a3b-90dc-421e-e063-6394a90acf5c2026-08-21WarningsExact identifier
unii: O414PZ4LPZ
AntispeticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLYour Military Exchangesd0ede39c-4b05-47c7-9c0b-9e893dcdb7232026-08-21Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK
Ouai Anti-DandruffSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5990c45f-f653-b403-e063-6394a90a329d2026-08-21WarningsExact identifier
unii: O414PZ4LPZ
Acne ScrubSALICYLIC ACIDWalmart Inc.5a76498e-a6f6-4e04-a2c7-245be947b0062026-08-21Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Tartar control plus AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLNice-Pak Products, LLC37be182d-16be-4edb-bccb-87c7cb5c39c22026-08-21Warnings, Adverse reactionsExact identifier
unii: RV6J6604TK

Reported adverse events (FAERS/openFDA)#

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