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 15 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl Rubbing Alcohol 70ISOPROPYL ALCOHOLDelon Laboratories (1990) Ltd.fb481568-0c51-421f-9b73-adb4c84645aa2026-06-22WarningsExact identifier
unii: ND2M416302
MedlineISOPROPYL ALCOHOLMedline Industries, LP495076e9-3187-6bfa-e063-6394a90a01f52026-06-22WarningsExact identifier
unii: ND2M416302
Subleef SKIN WART CORN REMOVERWART CORN REMOVERPutian Licheng District Zhijiancheng Trading Co., Ltd.54aeb166-d703-1d23-e063-6394a90a19a42026-06-20WarningsExact identifier
unii: O414PZ4LPZ
CVS Health Scalp ReliefSALICYLIC ACIDCVS Health8de46015-817c-4cd9-95f8-293424f2a5c42026-06-19WarningsExact identifier
unii: O414PZ4LPZ
GAVNZ WART REMOVER patchesSALICYLIC ACID 40% WART REMOVER PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.54839f38-dd77-eb80-e063-6294a90a2eed2026-06-18WarningsExact identifier
unii: O414PZ4LPZ
Pharmlitalia Psoriasis TreatmentSALICYLIC ACIDFoshan Sugar Max Cosmetics CO.,Ltd845a82f6-7d0e-416d-b5b0-bf788dca2f542026-06-18WarningsExact identifier
unii: O414PZ4LPZ
EpochSALICYLIC ACIDNSE Products, Inc.3084ac37-de1f-4218-9471-6a5ebf720eb92026-06-17WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcohol 91 percentISOPROPYL ALCOHOLP & L Development, LLCfcda76cb-63c4-4e81-9e0a-13be506a81502026-06-17WarningsExact identifier
unii: ND2M416302
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Musizlee WART REMOVERSALICYLIC ACID 1% WART REMOVERWenzhou Yuyuan Pharmaceutical Co., Ltd.545a9483-dc13-3675-e063-6294a90aebde2026-06-16WarningsExact identifier
unii: O414PZ4LPZ
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDLOreal USA Products Inc17b7a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
unii: O414PZ4LPZ
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDCosmetique Active Production17b8a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
unii: O414PZ4LPZ
Societe Clarity BacSALICYLIC ACIDSociete Clinical Skincare545130ce-46f9-c231-e063-6394a90a1ea82026-06-16WarningsExact identifier
unii: O414PZ4LPZ
ES Salicylic WashSALICYLIC ACIDElaine Sterling Enterprises543ab052-5aa9-6585-e063-6394a90af88f2026-06-16WarningsExact identifier
unii: O414PZ4LPZ
Societe Clear Skin PadsSALICYLIC ACIDSociete Clinical Skincare543a4347-d7d8-3050-e063-6294a90ab3a22026-06-16WarningsExact identifier
unii: O414PZ4LPZ
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
unii: O414PZ4LPZ
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
unii: O414PZ4LPZ
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
unii: O414PZ4LPZ
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact identifier
unii: O414PZ4LPZ
GlowBiotic Probiotic Acne CleanserSALICYLIC ACIDGlowbiotics546334bf-cf47-a1e5-e063-6394a90a590c2026-06-16WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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