FDA.reportPublic FDA data

NDC 68987-021 - PureLife APF

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
68987-021
Package NDCs from labels
68987-021-12
Manufacturer
PureLife Dental
Effective date
2014-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PureLife APF - PureLife DentalPureLife Dental2014-05-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68987-021-12PureLife APF125 g in 1 BOTTLE, PUMPAEROSOL, FOAM1251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68987-021PURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]11 package rows20140516_47ca5997-13e9-478a-b079-a4b6ee4dbf81.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7PURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
FLUORIDE IONACTIVE MOIETYQ80VPU408OPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
HYDROFLUORIC ACIDINACTIVE INGREDIENTRGL5YE86CZPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2PURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP0PURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
WaterINACTIVE INGREDIENT059QF0KO0RPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1EPURELIFE APF (SODIUM FLUORIDE) AEROSOL, FOAM [PURELIFE DENTAL]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 69 of 78 · 1,541 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PSY-stabilPHOSPHORIC ACID, AMANITA MUSCARIA FRUITING BODY, SEMECARPUS ANACARDIUM FRUIT, AVENA SATIVA FLOWERING TOP, CINCHONA OFFICINALIS BARK, STRYCHNOS IGNATII SEED, SCHOENOCAULON OFFICINALE SEED, AND PIPER METHYSTICUM ROOTPEKANA Naturheilmittel GmbH6e26d1a1-332a-44b3-bee6-b9d9b6c044082022-12-19WarningsExact identifier
unii: E4GA8884NN
PSY-stabilPHOSPHORIC ACID, AMANITA MUSCARIA FRUITING BODY, SEMECARPUS ANACARDIUM FRUIT, AVENA SATIVA FLOWERING TOP, CINCHONA OFFICINALIS BARK, STRYCHNOS IGNATII SEED, SCHOENOCAULON OFFICINALE SEED, AND PIPER METHYSTICUM ROOTPEKANA Naturheilmittel GmbH03701335-24e7-4a00-bc64-5400196a69772022-12-19WarningsExact identifier
unii: E4GA8884NN
OSS-regenPHOSPHORIC ACID, ANGOSTURA BARK, FERULA ASSA-FOETIDA RESIN, BELLIS PERENNIS, BRYONIA DIOICA ROOT, GUAIACUM OFFICINALE RESIN, RUTA GRAVEOLENS FLOWERING TOP, AND EQUISETUM ARVENSE TOPPEKANA Naturheilmittel GmbH83fcf98d-4d5a-49f4-9ea1-816515a64f772022-12-16WarningsExact identifier
unii: E4GA8884NN
CataraccARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM, EUPHRASIA, HYDROFLUORICUM AC., IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOS., PULSATILLA, SEPIA, SILICEA, TELLURIUM, THIOSINAMINUM, ZINC. MET.Newton Laboratories, Inc.eff981fd-5436-7c34-e053-2a95a90a3e8e2022-12-16WarningsExact identifier
unii: RGL5YE86CZ
VIREXARSENICUM ALB, BAPTISIA, BELLADONNA, ECHINACEA, EUPATORIUM PERF, GELSEMIUM, LYCOPODIUM, , NUX VOM, PHOSPHORICUM AC, PHOSPHORUS, PYROGENIUM, RHUS TOXWhite Manufacturing Inc. DBA Micro-West77b9e94e-e159-4b77-bd8a-9f5937ac29062022-12-02WarningsExact identifier
unii: E4GA8884NN
THYROPROCALCAREA IODATA, FERRUM IODATUM, KALI IODATUM, SPONGIA TOSTA, FUCUS VESICULOSUS, THYROIDINUM, GLANDULA SUPRARENALIS, HYPOPHYSIS, LAPIS ALBUS, HYDROFLUORICUM ACIDUMProBlene69b797a-678f-4173-9c6c-97b7ba436fbe2022-11-30WarningsExact identifier
unii: RGL5YE86CZ
LIBIDOPRODAMIANA, GALIUM, GLANDULA SUPRARENALIS, HEPAR, HYPOPHYSIS, KOREAN GINSENG, NUPHAR, ORCHITINUM, PHOSPHORICUM AC, POPULUS TREM, TESTOSTERONEProBlene73b5bcf-a2c7-41bb-a40d-fa645e9849a82022-11-30WarningsExact identifier
unii: E4GA8884NN
TestoPROAVENA SATIVA, DAMIANA, HAMAMELIS VIRGINIANA, KOREAN GINSENG, POPULUS TREMULOIDES, BARYTA CARBONICA, HEPAR SUIS, NUPHAR LUTEUM, ORCHITINUM SUIS, PHOSPHORICUM ACIDUM, SABAL SERULATA, SELENIUM METALLICUM, TESTOSTERONE, TRIBULUS TERRESTRIS, HORNY GOAT WEED, TONGKAT ALI, FENUGREEKProBlende00895d-db6e-4801-9cfe-a6a4d72359862022-11-30WarningsExact identifier
unii: E4GA8884NN
Adrenal SupportHUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.e7e01040-df38-4628-96d0-4df3420546a42022-11-09WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, ARSENICUM IODATUM, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.06fccf1a-2a70-4f29-8864-4577e6c39d9b2022-08-10WarningsExact identifier
unii: E4GA8884NN
Natrum FluoratumNATRUM FLUORATUMHahnemann Laboratories, INC.e54bdb28-890b-4869-e053-2995a90a8efd2022-08-02Exact identifier
unii: 8ZYQ1474W7
Acidum FluoricumACIDUM FLUORICUMHahnemann Laboratories, INC.e42ebbe6-1ef7-2d8d-e053-2a95a90a77942022-07-19Exact identifier
unii: RGL5YE86CZ
BHI SkinBERBERIS VULGARIS ROOT BARK, GRAPHITE, HYDROFLUORIC ACID, LYCOPODIUM CLAVATUM SPORE, PETROLATUM, TOXICODENDRON PUBESCENS LEAF, SEPIA OFFICINALIS JUICE, AND SULFURMediNatura Inc70ab2931-bd2d-43de-bb36-d019f78e3d732022-07-07WarningsExact identifier
unii: RGL5YE86CZ
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: E4GA8884NN
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Adrenal SupportARALIA QUINQUEFOLIA, HUMULUS LUPULUS, ADRENALINUM, CORTISONE ACETICUM, SELENIUM METALLICUM, THYROIDINUM (SUIS), ARSENICUM ALBUM, CALCAREA CARBONICA, CONVALLARIA MAJALIS, CROTALUS HORRIDUS, FERRUM METALLICUM, NUX VOMICA, PHOSPHORUS, SEPIA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.37a7f63c-4241-492b-af7c-7e5bbe0a08892022-06-21WarningsExact identifier
unii: E4GA8884NN

Reported adverse events (FAERS/openFDA)#

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