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 8 of 23 · 442 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLAlvogen Inc.0178a92c-62b1-d5cf-cf54-2c85af88a74a2025-11-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310169
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLNiagara Pharmaceuticals Inc.362a6b6d-862d-4322-87a8-5b3a07fbe1742025-11-24WarningsExact identifier
unii: 6DC9Q167V3
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 6DC9Q167V3
unii: 059QF0KO0R
Histamine BalancerALLIUM CEPA, GALPHIMIA GLAUCA, SABADILLA, APIS MELLIFICA, ESTRADIOL, KALI SULPHURICUM, GLANDULA SUPRARENALIS (BOVINE), HEPAR (BOVINE), INTESTINE (SUIS), STOMACH (SUIS), HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), AMBROSIA ARTEMISIAEFOLIA, CARBO VEGETABILIS, PEANUT, BLACK WALNUT, ENGLISH WALNUT, AMYGDALA AMARA, CASHEW, COCONUT, PECAN, BRAZIL NUT, TOMATO, SOLANUM TUBEROSUM, PIPER NIGRUM, EGGPLANT, RAPE SEED OIL, LINUM USITATISSIMUM, SESAME SEED, CHEESE (STILTON), LAC VACCINUM, BEEF, LAMB, PORK, CHICKEN, EGG,Nutritional Specialties, Inc.109b48f9-3588-49f0-ba02-397e09a477d12025-11-19WarningsExact identifier
unii: 4TI98Z838E
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R
EstradiolESTRADIOLNorthStar Rx LLC1c2cd11a-e010-20b2-e063-6294a90a52d52025-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
STERILE WATERWATERHenry Schein, Inc.f4087143-9868-4308-b96c-43657ee8ec282025-11-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bacteriostatic WaterBACTERIOSTATIC WATERProPharma Distribution42c6938e-f747-ae13-e063-6294a90a59a32025-11-04Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane Complete PFPROPYLENE GLYCOL EMULSIONAlcon Laboratories, Inc.798ffdde-1dba-4a3f-a0b6-937f9e958cca2025-11-03WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERICU Medical Inc.aab10f03-26ae-4dbc-a481-ef025e48b4052025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERICU Medical Inc.e3484bc6-ed7f-43ef-9d49-c131a8dff2dd2025-11-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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