FDA.reportPublic FDA data

NDC 61919-826-15 - SILDENAFIL

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
61919-826
Requested NDC
61919-826-15
Package NDCs from labels
61919-826-50, 61919-826-30, 61919-826-10, 61919-826-20, 61919-826-90, 61919-826-15
Manufacturer
DIRECT RX
Effective date
2023-05-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SILDENAFIL - DIRECT RXDIRECT RX2023-05-23HUMAN PRESCRIPTION DRUG LABEL
SILDENAFIL - DirectRXDirectRX2015-10-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
61919-826-102025-01-302cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-202025-01-302cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-302025-01-302cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-502025-01-302cef2736-6e10-d83d-e063-dadaa90ab31fSILDENAFIL
61919-826-902020-01-319d75b9d0-d273-f424-e053-dadaa90a57ceSILDENAFIL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-826-10SILDENAFIL10 in 1 BOTTLETABLET, FILM COATED1011
61919-826-20SILDENAFIL20 in 1 BOTTLETABLET, FILM COATED2011
61919-826-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED3011
61919-826-50SILDENAFIL50 in 1 BOTTLETABLET, FILM COATED5011
61919-826-90SILDENAFIL90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-826SILDENAFIL TABLET, FILM COATED [DIRECT RX]11Legacy NDC, 4 package rows20230524_3b3aae0f-4d1d-0244-e054-00144ff88e88.zip
61919-826SILDENAFIL TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20151020_c152953d-53a0-4f8b-91d7-fcd94024ad49.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-826-10EA - Each61919-8261f59faa3-c0ef-466b-8825-5b3e693c7cd912019-11-12
61919-826-15EA - Each61919-826e8159d6a-6fe5-4fad-98fb-c3bd3aadbf8312019-11-12
61919-826-20EA - Each61919-8261f6b53a1-952b-4f54-ae72-1808f1eb8f0e12022-11-07
61919-826-30EA - Each61919-826579f2eb5-f837-4117-a94d-2895d0177d2512019-11-12
61919-826-50EA - Each61919-8263536b2d8-adb3-4db6-a9c0-940a274c952d12019-08-06
61919-826-90EA - Each61919-82640557455-f8e7-42a6-a608-3dcf09640d3412016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL TABLET, FILM COATED [DIRECTRX]1

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 112 · 2,237 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILPreferred Pharmaceuticals, Inc.174ef537-e3e6-42bd-a478-47b930ddc7612026-08-31Warnings, Adverse reactionsExact identifier
application number: ANDA202659
rxcui: 314229
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILPreferred Pharmaceuticals Inc.878b4c44-cddc-42cb-b9b5-911451ad15302026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
SildenafilSILDENAFILPreferred Pharmaceuticals Inc.d887377e-90c5-44dc-8455-b23a6755b36f2026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILBryant Ranch Prepack96ae6733-cef9-46cf-bf4e-5368201943bd2026-08-19Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO
SILDENAFILSILDENAFILCardinal Health 107, LLCc5ac2265-393a-4fbe-b974-1dd0b9243ec82026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
Sildenafil CitrateSILDENAFILNuCare Pharmaceuticals,Inc.1b1ab00d-de9c-4614-e063-6394a90afcde2026-08-11Warnings, Adverse reactionsExact identifier
rxcui: 312950
unii: BW9B0ZE037

Reported adverse events (FAERS/openFDA)#

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