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 4 of 34 · 668 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
unii: PDC6A3C0OX
3ECARE Dual FormulaToothpastefor sensitiveteethPOTASSIUM NITRATE SODIUM MONOFLUOROPHOSPHATEHangzhou Namei Zhikang Technology Co., Ltd.533fc83e-a8cf-15c1-e063-6294a90a7b742026-06-02WarningsExact identifier
unii: RU45X2JN0Z
C-More Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUM, GLYCERINPROFOUND NUTRITION LIMITED78f04ecb-da5e-468c-81fe-70f7c26b76c22026-06-01WarningsExact identifier
unii: PDC6A3C0OX
Audiologists Choice Earwax Removal SystemCARBAMIDE PEROXIDEOaktree Products Inc.c9ad507b-341c-474f-aaa2-3c3a97a30dd82026-05-29WarningsExact identifier
unii: 31PZ2VAU81
Good Neighbor Pharmacy Earwax Removal DropsCARBAMIDE PEROXIDEAmerisource Bergen89eac1b0-c700-45b5-8478-da53ace72e162026-05-29WarningsExact identifier
unii: 31PZ2VAU81
Meijer Earwax Removal KitCARBAMIDE PEROXIDEMeijer Distribution Inc.a5f7bd55-55c3-4b0e-a16c-33bbea40536a2026-05-29WarningsExact identifier
unii: 31PZ2VAU81
Quality Choice Earwax Removal DropsCARBAMIDE PEROXIDEChain Drug Marketing Association, Inc.d8fd8102-114f-415d-9083-f98a63f9d1b32026-05-29WarningsExact identifier
unii: 31PZ2VAU81
Peep ClubGLYCERINPeep Club Eyecare Corp.513d1988-2827-28d8-e063-6294a90a8d1f2026-05-28WarningsExact identifier
unii: PDC6A3C0OX
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens5285403b-ab44-21a1-e063-6394a90a9fd02026-05-23WarningsExact identifier
unii: PDC6A3C0OX
Sensitivity Relief Fluoride FreePOTASSIUM NITRATEHealth and Natural Beauty USA Corpc23b2a83-ebc3-4bcf-a216-7693944dcfa02026-05-22WarningsExact identifier
unii: RU45X2JN0Z
Sensitivity and Gum with Cavity ProtectionPOTASSIUM NITRATE AND SODIUM FLUORIDEHealth and Natural Beauty USA Corp137d6935-19a3-499d-957c-820156eec7a52026-05-22WarningsExact identifier
unii: RU45X2JN0Z
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
unii: PDC6A3C0OX
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: PDC6A3C0OX
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERIN SUPPOSITORIESNeilmed Pharmaceuticals Inc.374a2ca3-ee04-09a7-e063-6394a90ab7602026-05-05WarningsExact identifier
unii: PDC6A3C0OX
ear dropsCARBAMIDE PEROXIDE 6.5%Bionpharma Inc.e8bcf92c-ad32-49d5-e053-2995a90ae0c62026-04-27WarningsExact identifier
unii: 31PZ2VAU81

Reported adverse events (FAERS/openFDA)#

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