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 17 of 120 · 2,396 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEALSURE WART REMOVERSALICYLIC ACID 17% WART REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a466b8e-5684-91e8-e063-6394a90a67132026-06-12WarningsExact identifier
unii: O414PZ4LPZ
HEALSURE WART MOLES REMOVERSALICYLIC ACID 17% WART MOLES REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4693f9-37d5-b8da-e063-6394a90a4ef32026-06-12WarningsExact identifier
unii: O414PZ4LPZ
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBTotal Operations Management LLC DBA:Bestmade Natural Products Micro540ff544-b406-70e2-e063-6394a90ae4512026-06-12WarningsExact identifier
unii: O414PZ4LPZ
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBTotal Operations Management LLC DBA:Bestmade Natural Products Micro54113d1f-e8e7-6b4c-e063-6394a90a0edf2026-06-12WarningsExact identifier
unii: 059QF0KO0R
Butterflys tear MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52226dfd-eafa-42d7-e063-6394a90a16ef2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Butterflys tear WART REMOVERSALICYLIC ACID 17% SKIN TAG REMOVERJiangxi Yudexi Pharmaceutical Co., LTD52230e87-2358-1126-e063-6394a90aef432026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Butterflys tear WART REMOVER PatchesSALICYLIC ACID 1% WART REMOVER PATCHESJiangxi Yudexi Pharmaceutical Co., LTD52a1905e-c897-9dd1-e063-6294a90af10c2026-06-12WarningsExact identifier
unii: O414PZ4LPZ
Swiftalyn Antifungal Scalp Shampoo.SALICYLIC ACID 2%GENUINE INNOVATION LTD53f84e9f-ecc1-dfc2-e063-6394a90af2432026-06-11WarningsExact identifier
unii: O414PZ4LPZ
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
Proven Acne CleanserSALICYLIC ACIDProven Skincare316702b8-4f9d-0a42-e063-6394a90ad8e12026-06-11WarningsExact identifier
unii: O414PZ4LPZ
Proven Acne CleanserSALICYLIC ACIDProven Skincare31a29bdd-a218-247a-e063-6294a90a8cee2026-06-11WarningsExact identifier
unii: O414PZ4LPZ
Joymeey WART CORN LiquidSALICYLIC ACID 17% WART CORN LIQUIDJiangxi Yudexi Pharmaceutical Co., LTD5405c1ba-6677-7a8e-e063-6294a90af1a82026-06-11WarningsExact identifier
unii: O414PZ4LPZ
EVR Alcohol Prep PadsLSOPROPYL ALCOHOLJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD5406ba2f-6729-b9e7-e063-6394a90ac5532026-06-11WarningsExact identifier
unii: ND2M416302
BM BM11 DROPSACIDUM SALICYLICUM, BELLADONNA, COFFEA CRUDA, GELSEMIUM, IRIS VERS, MELILOTUS OFF, SPIGELIA, USNEA BARBBM Private Limited53e7d586-805b-f1b3-e063-6294a90a118d2026-06-10WarningsExact identifier
unii: O414PZ4LPZ
DERMACLEARRX Wart RemoverDERMACLEARRX WART REMOVERShenzhen Earth Surface Trading Co., Ltd.53f253d5-a918-77d2-e063-6394a90ac8d62026-06-10WarningsExact identifier
unii: O414PZ4LPZ
Isopropyl alcoholISOPROPYL ALCOHOLCVS PHARMACY, INCb30468f6-7a1b-4165-916f-36df21eb10e52026-06-09WarningsExact identifier
unii: ND2M416302
Good Molecules Acne Foaming CleanserSALICYLIC ACIDTwincraft Inc.4911ef14-b465-3398-e063-6394a90a9c9a2026-06-09WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidLIQUID WART REMOVERChain Drug Marketing Association Inc.339da513-6e2a-8359-e063-6294a90a075c2026-06-09WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED PLANTAR WART REMOVERChain Drug Marketing Association342a6b6c-3af7-d4fc-e063-6294a90a142c2026-06-09WarningsExact identifier
unii: O414PZ4LPZ
Salicylic AcidMEDICATED CORN REMOVERChain Drug Marketing Association3402dfc5-bc36-9c2f-e063-6394a90a31742026-06-09WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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