FDA.reportPublic FDA data

NDC 49035-552 - Ear Wax Removal System

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
49035-552
Package NDCs from labels
49035-552-01
Manufacturer
Walmart | Product Quest Mfg
Effective date
2018-01-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ear Wax Removal Drops Well at Walgreens - Walmart | Product Quest MfgWalmart | Product Quest Mfg2018-01-02HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-552-01Ear Wax Removal System15 mL in 1 BOTTLESOLUTION/ DROPS15 mL6.5 g in 100mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-552EAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]3Unmatched20180102_ea835ce6-4413-4bf3-8ce8-89a3489a7dbf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Carbamide PeroxideACTIVE INGREDIENT31PZ2VAU81EAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VEAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XEAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXEAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]1
Oxyquinoline SulfateINACTIVE INGREDIENT61VUG75Y3PEAR WAX REMOVAL SYSTEM (CARBAMIDE PEROXIDE - 6.50%) KIT [WALMART]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 36 of 36 · 715 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Kids ReliefDROSERA, ARNICA MONTANA, BRYONIA, IPECACUANHA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEAHomeolab International (Canada) incda5677ec-63fd-4467-9755-479d0ab51df52019-12-10WarningsExact identifier
unii: FGL3685T2X
Real ReliefDROSERA, ARNICA MONTANA, BRYONIA, CETRARIA ISLANDICA, COCCUS CACTI, CORALLIUM RUBRUM, STANNUM METALLICUM, CAMOMILLA, COFFEA CRUDEAHomeolab International (Canada) incfc6a509a-f4c0-47e7-8693-906ba6e039232019-12-10WarningsExact identifier
unii: FGL3685T2X
GUNA-DIZZY.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -Guna spac5f4a798-e628-4388-a98d-7449dd92f2d62018-12-21WarningsExact identifier
unii: T5L8T28FGP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
61cc4d9f-26ea-190a-e053-2991aa0a1d9fea835ce6-4413-4bf3-8ce8-89a3489a7dbf2018-01-02WarningsExact identifier
spl id: 61cc4d9f-26ea-190a-e053-2991aa0a1d9f
spl set id: ea835ce6-4413-4bf3-8ce8-89a3489a7dbf
ENT Essentials Ear Wax RemvoerCARBAMIDE PEROXIDEWisconsin Pharmacal Company5d7d078f-ef8a-8aa7-e053-2a91aa0ae3b12017-11-08WarningsExact identifier
rxcui: 702050
unii: 31PZ2VAU81
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
FIND BICHON CLEANSING MASKGLYCERINPioom Cosmetic Co.,ltd50b7db48-7b55-6df4-e054-00144ff88e882017-05-30WarningsExact identifier
unii: PDC6A3C0OX
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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