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 10 of 23 · 442 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Systane COMPLETEPROPYLENE GLYCOLAlcon Laboratories, Inc.2df0de02-a3e2-471a-9e10-040c3fba75fe2025-08-08WarningsExact identifier
unii: 6DC9Q167V3
Systane BalancePROPYLENE GLYCOLAlcon Laboratories, Inc.c7b1a03a-a5f2-409e-a34a-d6f166671de52025-08-07WarningsExact identifier
unii: 6DC9Q167V3
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: 6DC9Q167V3
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: 6DC9Q167V3
Systane COMPLETE PFPROPYLENE GLYCOLAlcon Laboratories, Inc.99b63d62-1cf0-4f28-8760-773917c2538a2025-07-29WarningsExact identifier
unii: 6DC9Q167V3
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions13f9c41b-417c-45e4-9a59-baf774fca78d2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINALESTRADIOLEncube Ethicals, Inc.1c61e837-4196-4b4d-9545-96b2d7c66f132025-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 310169
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.f4efb0bf-b96f-4e20-a0f2-0806ab92b2d42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
EstradiolESTRADIOLCoupler LLC37c99e4d-fb0d-0e6e-e063-6394a90a69c82025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.d28bec8f-762e-4f05-a20d-96a42970d6a72025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC0c8a07a4-5762-eaf4-e063-6394a90a54ff2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen CreamESTRIOL,ESTRADIOLSHYNE BRANDSc4d3860f-c211-b18c-e053-2a95a90a44742025-06-01WarningsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen Cream - 3.6ozESTRIOL,ESTRADIOLSHYNE BRANDS/BIOLabs PRO37d33647-9790-35a8-e063-6294a90a2ad92025-06-01WarningsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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