FDA.reportPublic FDA data

NDC 47649-9001-2 - Dr. Whitiss (8.3%)

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
47649-9001
Requested NDC
47649-9001-2
Package NDCs from labels
47649-9001-2, 47649-9001-3, 47649-9001-1
Manufacturer
Nibec Co., Ltd
Effective date
2017-11-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dr. Whitiss (8.3%) - Nibec Co., LtdNibec Co., Ltd2017-11-27HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
47649-9001-12024-01-30C16284748780-11030e365-2da7-111a-e063-dadaa90a10e2Drug Facts
47649-9001-32024-01-30C16284748780-11030e365-2da7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47649-9001-1Dr. Whitiss (8.3%)5 g in 1 PACKAGEGEL, DENTIFRICE53
47649-9001-2Dr. Whitiss (8.3%)2 g in 1 CYLINDERGEL, DENTIFRICE23
47649-9001-3Dr. Whitiss (8.3%)4 in 1 PACKAGEGEL, DENTIFRICE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47649-9001DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]3Legacy NDC, 3 package rows20171128_1f4d7ad3-433c-40b3-842e-73a327214d86.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU81DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]1
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9VDR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXDR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]1
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0ZDR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZDR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]1
waterINACTIVE INGREDIENT059QF0KO0RDR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]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 2 of 34 · 668 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ROROBELL WAWA Sensitive Teeth ToothHYDRATED SILICA, POTASSIUM NITRATE, SODIUM FLUORIDEROROBELL58344745-544b-5f24-e063-6294a90ad5a72026-08-04WarningsExact identifier
unii: RU45X2JN0Z
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
unii: RU45X2JN0Z
Lornamead Natural WhiteFLUORIDELornamead Products9d7d08d7-8ca4-4b05-8b74-3bfa372b16082026-07-29WarningsExact identifier
unii: RU45X2JN0Z
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
unii: RU45X2JN0Z
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Quality Choice Natural WhiteFLUORIDECHAIN DRUG MARKETING ASSOCIATION INC561a75c2-a40c-ba7c-e063-6294a90aa1192026-07-08WarningsExact identifier
unii: RU45X2JN0Z
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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