FDA.reportPublic FDA data

NDC 63629-8654-01 - Estradiol Vaginal

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
63629-8654
Requested NDC
63629-8654-01
Package NDCs from labels
63629-8654-1, 63629-8654-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Vaginal - Bryant Ranch PrepackBryant Ranch Prepack2024-07-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8654-1Estradiol Vaginal42.5 g in 1 TUBECREAM42.5106
63629-8654-1Estradiol Vaginal1 in 1 CARTONCREAM1106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8654ESTRADIOL VAGINAL (ESTRADIOL) CREAM [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240918_e7b15ec3-e195-44a6-bdd7-9b6de2b235b8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8654-1GM - Gram63629-86547d550314-c012-476b-8b2f-73556362f34d12023-08-08

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 14 of 23 · 442 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Baby WipesPROPYLENE GLYCOLShandong Yayun Sanitary Products Co., Ltd.aeb9a12c-955f-5030-e053-2995a90a2dd62024-11-20WarningsExact identifier
unii: 6DC9Q167V3
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
unii: 6DC9Q167V3
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: A2I8C7HI9T
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3518120e-cc44-4d70-8a20-0ef2dce9a3c62024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstrogensESTRADIOL, FOLLICULINUM, OOPHORINUM (SUIS)Energique, Inc.e0686139-824f-42bc-8610-bb003d7edc3f2024-10-24WarningsExact identifier
unii: 4TI98Z838E
ESTROGEN PHENOLICESTRADIOL,Energique, Inc.716cd86c-af47-45a6-b710-fed421e78fb52024-10-24WarningsExact identifier
unii: 4TI98Z838E
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.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 2KR89I4H1Y
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Household DetoxPTELEA TRIFOLIATA, ALLIUM SATIVUM, PETROLEUM, CARBONEUM SULPHURATUM, ALUMINA, BENZINUM, BISPHENOL A, CARBOLICUM ACIDUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PARAFFINUM, PHENACETINUM, SODIUM CARBOXYMETHYL CELLULOSE, FOLLICULINUM, ANTIPYRINUM, DIOXIN, DIETHYLSTILBESTROL, TEFLONDeseret Biologicals, Inc.7e32c1f4-c88e-43d0-9f6c-de736d358d462024-09-27WarningsExact identifier
unii: A2I8C7HI9T
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 6DC9Q167V3
unii: 368GB5141J
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 4TI98Z838E
SootheGLYCERIN AND PROPYLENE GLYCOLBausch & Lomb Incorporatedfef002ea-c4bd-4486-a42e-1bbd9d73d28d2024-09-20WarningsExact identifier
unii: 6DC9Q167V3
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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