FDA.reportPublic FDA data

NDC 42291-962-11 - Yuvafem

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
42291-962
Requested NDC
42291-962-11
Package NDCs from labels
42291-962-11, 42291-962-08, 42291-962-18
Manufacturer
AvKARE
Effective date
2026-01-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Yuvafem - AvKAREAvKARE2026-01-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-962-08Yuvafem8 in 1 CARTONTABLET89
42291-962-11Yuvafem1 in 1 APPLICATORTABLET19
42291-962-18Yuvafem18 in 1 CARTONTABLET189

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-962YUVAFEM (ESTRADIOL) TABLET [AVKARE]8Current NDC, Legacy NDC, 3 package rows20240111_d20abc9a-8f47-e274-c9b1-b71c9489761f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-962-08EA - Each42291-9621e865e1b-5df2-422c-bcdf-4889a01d7a0012016-12-07
42291-962-11EA - Each42291-962b6e839c4-ff41-493e-b670-a91f756e23f612025-05-14
42291-962-18EA - Each42291-962cd5dff2b-a8de-4bdb-8f73-395b7066d49512016-12-07

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 1 of 11 · 209 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estriora CreamESTRIOL AND ESTRADIOL CREAMGuangzhou Shunfei Network Technology Co., Ltd.5a53c026-aa7c-6c09-e063-6394a90a36e12026-08-31WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutionsc8a2d29c-299c-4559-b859-87b303a4af812026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
GynobalanceDEHYDROEPIANDROSTERONE, ESTRADIOL, PREGNENOLONE, PROGESTERONE, TESTOSTERONEBioActive Nutritional, Inc.61fa6e6e-42f5-4992-87b5-0770218abc8c2026-08-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTrigen Laboratories, LLCe84ad638-6768-41aa-b2b8-e2514ef638812026-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
Dr. Shitong Photon Energy Eye Care LiquidTETRAHYDROZOLINE HCL 0.05% HYPROMELLOSE 0.3% DR. SHITONG PHOTON ENERGY EYE CARE LIQUIDWenzhou Yuyuan Pharmaceutical Co., Ltd.58ace434-55ef-17ef-e063-6294a90aa8782026-08-10WarningsExact identifier
unii: 3NXW29V3WO
MinivelleESTRADIOLNoven Therapeutics, LLC6c5c47ab-28ee-11e1-bfc2-0800200c9a662026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLRedpharm Drug5718f042-e8c0-b721-e063-6294a90a5bef2026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutionse166bdf6-eb60-49b8-9747-2a33c3e3461b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEA-S Medication Solutions1521007a-546d-421e-99e1-e10d90c0b0902026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.ff28c624-906d-459c-8b8c-27cb1a664e122026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Estradiol VaginalESTRADIOLRedpharm Drug546c168d-2a85-69b6-e063-6294a90a22ac2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepacke6bf2abc-71ae-4e79-a37b-164c98ba746a2026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions34bcec8e-c7a6-4a1c-9884-4d4efe024bb92026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLREMEDYREPACK INC.41f7a56c-4ce3-4cc6-803e-1ff662efef902026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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