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 4 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Head and Shoulders Scalp Soothe CoolingSALICYLIC ACIDThe Procter & Gamble Manufacturing Company5a87ed71-87e7-a7b7-e063-6294a90ac8972026-09-02WarningsExact identifier
unii: O414PZ4LPZ
Beisitian FACIAL BUMP REFINING ESSENCESALICYLIC ACID 2% FACIAL BUMP REFINING ESSENCEWenzhou Yuyuan Pharmaceutical Co., Ltd.5a6784cd-93d3-aecc-e063-6294a90af0212026-09-01WarningsExact identifier
unii: O414PZ4LPZ
Wart Remover PatchesSALICYLIC ACID 40%Guangzhou Chuanglian Zhida Trading Co., Ltd5a690660-543c-ac83-e063-6394a90ab2112026-09-01WarningsExact identifier
unii: O414PZ4LPZ
DrAny WART REMOVERSALICYLIC ACIDHong Kong Juxin Negosyo Kag Komersyo Co., Limited5a6b7878-060a-d528-e063-6394a90a42152026-09-01WarningsExact identifier
unii: O414PZ4LPZ
Medline Alcohol Swabstick TriplesISOPROPYL ALCOHOLMedline Industries, LPe7759368-97c5-4b10-9bca-c197aeb62e462026-09-01WarningsExact identifier
unii: ND2M416302
YEHOYOD WART REMOVER PATCHESSALICYLIC ACID 40%Shenzhen Xuesiang Trading Co., Ltd5a774348-64e6-5cbe-e063-6294a90a7a2b2026-09-01WarningsExact identifier
unii: O414PZ4LPZ
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: RV6J6604TK
INVISIBLE ACNE PATCHESSALICYLIC ACID 0.5%Global America Group LLC1527e15f-472f-4e05-adb6-c2e561f503cf2026-08-31WarningsExact identifier
unii: O414PZ4LPZ
70% Isopropyl AlcoholISOPROPYL ALCOHOLUpLift Brands, LLC8ae12375-3a95-475c-9600-17c51a9103f72026-08-31Warnings, Adverse reactionsExact identifier
unii: ND2M416302
OLNUITEXL WART REMOVERSALICYIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5a41ed8c-8fdb-1c8c-e063-6394a90afd4d2026-08-30WarningsExact identifier
unii: O414PZ4LPZ
The Acne Spot TreatmentSALICYLIC ACID SPOTSpotless, Inc.4a1a3716-9eaf-6be4-e063-6294a90a31c32026-08-30WarningsExact identifier
unii: O414PZ4LPZ
Orraya WART REMOVER LiquidSALICYLIC ACID 40% WART REMOVER LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.5a2cf1de-789c-04b0-e063-6394a90ac59e2026-08-29WarningsExact identifier
unii: O414PZ4LPZ
Oil Free Acne WashSALICYLIC ACID 2%Your Military Exchanges57f06989-3ffa-4cd3-bde5-9d3cc639ac4d2026-08-28Warnings, Adverse reactionsExact identifier
unii: O414PZ4LPZ
Invisible Wart Remover StripsINVISIBLE WART REMOVER STRIPSShenzhen Chaoxiji Technology Co.,Ltd.5a01c594-eaab-30ab-e063-6294a90af3872026-08-27WarningsExact identifier
unii: O414PZ4LPZ
BNGDOJY WART REMOVER LiquidSALICYLIC ACID 17% WART REMOVER LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.5a04fe28-828b-c1fc-e063-6294a90a52592026-08-27WarningsExact identifier
unii: O414PZ4LPZ
Proactivplus Pore Clearing TreatmentSALICYLIC ACIDAlchemee, LLC334efe89-3775-5ddb-e063-6294a90ae3a82026-08-27WarningsExact identifier
unii: O414PZ4LPZ
GENTLE ACNE CLEANSERSALICYLIC ACIDDrmtlgy, LLC2abed972-3fae-4ef0-abb6-1883457e98be2026-08-26WarningsExact identifier
unii: O414PZ4LPZ
RAVN Mens Back AcneSALICYLIC ACIDNorth Forge Brands LLC4a512df2-4ad7-495c-868a-1f4d0a8863912026-08-26WarningsExact identifier
unii: O414PZ4LPZ
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Stone Hand SanitizerISOPROPYL ALCOHOLhandetizer, LLC.59f821e0-b129-5c39-e063-6294a90a47a02026-08-26WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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