FDA.reportPublic FDA data

NDC 67938-2001-2 - EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER

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
67938-2001
Requested NDC
67938-2001-2
Package NDCs from labels
67938-2001-2, 67938-2001-1
Manufacturer
Elizabeth Arden, Inc
Effective date
2013-07-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DIMETHICONE - Elizabeth Arden, IncElizabeth Arden, Inc2013-07-29HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-2001-12020-01-31C16284748780-19d75b9d0-ef08-f424-e053-dadaa90a57ce242214

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-2001-1EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER1 in 1 BOXCREAM11
67938-2001-2EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER45 g in 1 JARCREAM451

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-2001EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20130730_b03c3248-aeea-47fc-b354-f73a93a8d1e6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
BENZYL SALICYLATEINACTIVE INGREDIENTWAO5MNK9TUEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
CITRONELLOL ACETATE, (R)-INACTIVE INGREDIENT9X45FJL446EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
DIMETHICONOL (40 CST)INACTIVE INGREDIENT343C7U75XWEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
GERANIOLINACTIVE INGREDIENTL837108USYEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
GLYCERYL BEHENATE/EICOSADIOATEINACTIVE INGREDIENT73CJJ317SREIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
GLYCERYL CITRATEINACTIVE INGREDIENT4987GT719IEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
ISONONYL ISONONANOATEINACTIVE INGREDIENTS4V5BS6GCXEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
ISOPROPYL PALMITATEINACTIVE INGREDIENT8CRQ2TH63MEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
LANOLININACTIVE INGREDIENT7EV65EAW6HEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
MICROCRYSTALLINE WAXINACTIVE INGREDIENTXOF597Q3KYEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
OLEYL ERUCATEINACTIVE INGREDIENT753W099NQ6EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
SYNTHETIC WAX (1200 MW)INACTIVE INGREDIENTQ3Z4BCH099EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, INC]1
TRIISOSTEARININACTIVE INGREDIENT71503RH8KGEIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER (DIMETHICONE) CREAM [ELIZABETH ARDEN, 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 88 of 135 · 2,684 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Drs. ACNE CLEARSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACYd6faa57c-d081-b57c-e053-2a95a90a79262025-01-09WarningsExact identifier
unii: O414PZ4LPZ
Anti-Gas StripSIMETHICONECalmourc1576ee9-69ff-41ff-b2d0-7703c8fa8edd2025-01-09WarningsExact identifier
unii: 92RU3N3Y1O
Anti-Diarrheal/Anti-Gas Multi-Symptom ReliefLOPERAMIDE HYDROCHLORIDE 2MG, SIMETHICONE 125MGWal-Mart Stores, Inc.a4d5dd69-22cf-4d00-b539-133886c09e372025-01-09WarningsExact identifier
unii: 92RU3N3Y1O
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
unii: 4T6H12BN9U
innisfree Gentle Retinol Salicylic Acne SerumSALICYLIC ACID GELInnisfree Corporation2b38b6f2-0de5-581b-e063-6394a90acd552025-01-08WarningsExact identifier
unii: O414PZ4LPZ
SimethiconeSIMETHICONEAMZ789 LLCbfaaf4e0-ff87-0fb9-e053-2a95a90a5aa22025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
Simethicone 250mgSIMETHICONE 250MGAMZ789 LLCfcc2ef8b-9181-2c59-e053-6394a90adcc12025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
unii: O414PZ4LPZ
unii: R0ZB2556P8
A0A0 Rice Ceramide Anti Wrinkle Age Essence Box SetBIFIDA FERMENT LYSATE,ORYZA SATIVA (RICE) EXTRACT,CERAMIDE NP,COLLAGEN,TOCOPHEROL.Guangdong Junhui Biotechnology Co., LTD22736b2d-45a0-49b6-e063-6394a90a7b0b2025-01-08WarningsExact identifier
unii: R0ZB2556P8
Body Milk for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED OIL,BUTYROSPERMUM PARKII (SHEA) BUTTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,THEOBROMA CACAO (COCOA) SEED BUTTERGuangzhou Senmai Biotechnology Co.1dcd94dc-214d-de72-e063-6294a90a695f2025-01-08WarningsExact identifier
unii: R0ZB2556P8
Body oil for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL ,TOCOPHEROL,ADANSONIA DIGITATA SEED 0IL,MORINGA OLEIFERA SEED 0IL,THEOBROMA CACAO (COCOA) SEED BUTTER,ECHIUM PLANTAGINEUM SEED OIL,SESAMUM INDICUM (SESAME) SEED 0ILGuangzhou Senmai Biotechnology Co.1daeb2e8-f18c-06c3-e063-6294a90a63852025-01-08WarningsExact identifier
unii: R0ZB2556P8
AOA0 Snail Ginseng CreamSNAIL SECRETION FILTRATE,PANAX GINSENG ROOT EXTRACT,COLLAGEN,TOCOPHEROL,ASCORBIC ACID.Guangdong Junhui Biotechnology Co., LTD22873a99-1032-f4ec-e063-6394a90a64322025-01-08WarningsExact identifier
unii: R0ZB2556P8
Massage cream for stretch marksHELIANTHUS ANNUUS (SUNFLOWER) SEED 0IL,BUTYROSPERMUM PARKII (SHEA) BUTER,ARGANIA SPINOSA KERNEL 0IL,TOCOPHEROL,CENTELLA ASIATICA EXTRACT,CERAMIDE NP,SOLUBLE COLLAGEN,HYDROLYZED ELASTIN,PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OILGuangzhou Senmai Biotechnology Co.1dce7cf1-1fb8-e14e-e063-6394a90ae34a2025-01-08WarningsExact identifier
unii: R0ZB2556P8
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
unii: T5L8T28FGP
extra strength Gas Relief cherry cremeSIMETHICONEAmerisource Bergen1e8e8d85-10e2-1273-e063-6394a90a15582025-01-08WarningsExact identifier
unii: 92RU3N3Y1O
Loperamide Hydrochloride and SimethiconeLOPERAMIDE HYDROCHLORIDE AND SIMETHICONEAurohealth LLC769e3cc0-6be9-4ab6-88e1-08803d698ef72025-01-07WarningsExact identifier
unii: 92RU3N3Y1O
Nutricentials Here You Glow Exfoliating TonerSALICYLIC ACIDNSE Products, Inc.ecf6c01b-50e5-4cfd-8ac3-0027cdc33f902025-01-07WarningsExact identifier
unii: O414PZ4LPZ
Wart RemoverSALICYLIC ACIDPharmaplast SAEa581fcf8-b406-48af-b358-87531e3486a22025-01-07WarningsExact identifier
unii: O414PZ4LPZ
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 8CRQ2TH63M
unii: 4T6H12BN9U
unii: O414PZ4LPZ
Cure-Aid Corn PlastersSALICYLIC ACIDPharmaplast SAE31a48f6a-37f5-4779-8040-0b13268b73502025-01-07WarningsExact identifier
unii: O414PZ4LPZ

Reported adverse events (FAERS/openFDA)#

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