FDA.reportPublic FDA data

NDC 61958-1102 - COMPLERA Access

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
61958-1102
Package NDCs from labels
61958-1102-5
Manufacturer
Gilead Sciences, Inc.
Effective date
2025-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
COMPLERA Access - Gilead Sciences, Inc.Gilead Sciences, Inc.2025-07-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1102-52024-09-25C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011
61958-1102-52024-07-30C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011
61958-1102-32020-07-22C16284748780-1ab0e2407-349c-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use COMPLERA safely and effectively. See full prescribing information for COMPLERA. COMPLERA™ (emtricitabine, rilpivirine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2011

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1102-5COMPLERA Access30 in 1 BOTTLETABLET, FILM COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1102COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]91 package rows20240927_9176bf31-c889-47bd-861c-f2d3fc37ab8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4SCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
RILPIVIRINE HYDROCHLORIDEACTIVE INGREDIENT212WAX8KDDCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900ICOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
EMTRICITABINEACTIVE MOIETYG70B4ETF4SCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
RILPIVIRINEACTIVE MOIETYFI96A8X663COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
TRIACETININACTIVE INGREDIENTXHX3C3X673COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]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 76 of 116 · 2,306 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Almay Healthy Biome Makeup LightHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a948e37-0554-d953-e063-6394a90a75e62024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup FairHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a947e1d-286f-a939-e063-6394a90a07192024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup TanHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94a668-24cb-e0f2-e063-6294a90a79d32024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome Makeup MediumHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmay2a94c0a2-8a47-39b9-e063-6394a90acf8c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20TITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a962944-9155-9b70-e063-6294a90ac5352024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 MediumTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a96811c-3ea6-15bc-e063-6394a90ac3bd2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Normal to Dry SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp414538d6-9108-54bf-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Preo and Protect PrimerTITANIUM DIOXIDE, ZINC OXIDE, OCTINOXATE PRIMERRevlon Consumer Products Corp8eebf23e-7fce-dfc0-e053-2995a90ae3222024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon PhotoReady BB Cream Skin PerfectorOCTINOXATE, OCTISALATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410ca372-4698-029d-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Colorstay Liquid Makeup for Oily to Combination SkinZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp410d1cb2-6c92-1ca3-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON PHOTOREADY INSTA-FIX MAKEUPTITANIUM DIOXIDE, ZINC OXIDERevlon Consumer Products Corp442f2a06-47c0-2522-e054-00144ff88e882024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Revlon Youth FXZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp442dec1e-032c-28de-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup MediumTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a971e38-af63-e069-e063-6294a90a8f772024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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