FDA.reportPublic FDA data

NDC 80425-0503-01 - SILDENAFIL CITRATE

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
80425-0503
Requested NDC
80425-0503-01
Package NDCs from labels
80425-0503-1, 80425-0503-2, 80425-0503-3, 80425-0503-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2025-03-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SILDENAFIL CITRATE - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2025-03-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0503-1SILDENAFIL CITRATE30 in 1 BOTTLETABLET301
80425-0503-2SILDENAFIL CITRATE60 in 1 BOTTLETABLET601
80425-0503-3SILDENAFIL CITRATE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0503SILDENAFIL CITRATE TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250322_30cb7d6a-ce40-c794-e063-6294a90a6861.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0503-1EA - Each80425-05030a071a5e-9090-4fdf-9649-cd375bc8705d12025-05-14
80425-0503-2EA - Each80425-05036a6a2fc1-d2a8-48a5-bc7c-f3dd17d1064012025-05-14
80425-0503-3EA - Each80425-050353c554e0-15da-4bcd-afb5-cc8b9749b0e612025-05-14

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 5 of 138 · 2,758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.e1af7b6a-378e-4337-858f-85a926eec1022026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
SildenafilSILDENAFILPD-Rx Pharmaceuticals, Inc.4e3034af-bee5-4df4-8beb-fbd2b510ad732026-07-07Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILAmneal Pharmaceuticals NY LLCa1c3a2a2-8cf5-41c3-9c86-54290570d9162026-07-06Warnings, Adverse reactionsExact identifier
rxcui: 314229
rxcui: 312950
rxcui: 314228
unii: BW9B0ZE037
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFIL CITRATEEugia US LLCbb92d686-a81e-4b91-8048-693af0534cb32026-07-01Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILBryant Ranch Prepack486dcfc4-f07a-4a78-86f0-f1c5ae448dc12026-06-29Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SildenafilSILDENAFILBryant Ranch Prepacke22902bd-e5a8-4df6-ae77-8a0a1484cc502026-06-29Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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