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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61958-1102-5	2024-09-25	C162847	48780-1	ab0e2407-349c-f274-e053-dbdaa90a6471	These 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
61958-1102-5	2024-07-30	C162847	48780-1	ab0e2407-349c-f274-e053-dbdaa90a6471	These 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
61958-1102-3	2020-07-22	C162847	48780-1	ab0e2407-349c-f274-e053-dbdaa90a6471	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-1102-5	COMPLERA Access	30 in 1 BOTTLE	TABLET, FILM COATED	30		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-1102	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	9	1 package rows	20240927_9176bf31-c889-47bd-861c-f2d3fc37ab8d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
EMTRICITABINE	ACTIVE INGREDIENT	G70B4ETF4S	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
RILPIVIRINE HYDROCHLORIDE	ACTIVE INGREDIENT	212WAX8KDD	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
TENOFOVIR DISOPROXIL FUMARATE	ACTIVE INGREDIENT	OTT9J7900I	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
EMTRICITABINE	ACTIVE MOIETY	G70B4ETF4S	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
RILPIVIRINE	ACTIVE MOIETY	FI96A8X663	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
TENOFOVIR ANHYDROUS	ACTIVE MOIETY	W4HFE001U5	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	COMPLERA ACCESS (EMTRICITABINE, RILPIVIRINE HYDROCHLORIDE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	COMPLERA 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 49 of 116 · 2,315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Non-tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30dd2f6b-5dcc-b081-e063-6394a90ae5f1	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30dc6e23-ecca-ed0b-e063-6294a90a7951	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30ddc3d7-76df-3344-e063-6294a90a65ae	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Physical Block Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Tucson Acne Clinic	30ddf80c-8496-0f47-e063-6394a90afc18	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Advanced Lip Guard	TITANIUM DIOXIDE, ZINC OXIDE	ADVANCED DERMATOLOGY	32e66ff3-ae1a-4a2a-e063-6294a90a7963	2025-12-09		Exact identifier unii: 15FIX9V2JP
Original Tint	TITANIUM DIOXIDE, ZINC OXIDE	L.S. MOORE LLC	37f1e019-32c4-b733-e063-6394a90aca28	2025-12-09		Exact identifier unii: 15FIX9V2JP
Original Tint	TITANIUM DIOXIDE, ZINC OXIDE	L.S. MOORE LLC	37f2e363-e85f-f601-e063-6294a90ab120	2025-12-09		Exact identifier unii: 15FIX9V2JP
Original Tint	TITANIUM DIOXIDE, ZINC OXIDE	L MOORE AESTHETICS	37f1ac8c-3bfb-10da-e063-6294a90a8ca8	2025-12-09		Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen Dry Touch NT	TITANIUM DIOXIDE, ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	334ffc49-3196-0995-e063-6394a90ad559	2025-12-09		Exact identifier unii: 15FIX9V2JP
Foam Weightless Sunscreen Non-Tinted Drytouch NT	TITANIUM DIOXIDE, ZINC OXIDE	Cutis Wellness Dermatology And Dermatopathology PLLC	335ec22c-6a9a-c4d1-e063-6394a90ac0b0	2025-12-09		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	323356ea-31a0-6ff0-e063-6294a90a135c	2025-12-09		Exact identifier unii: 15FIX9V2JP
Non-Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32330376-5db0-202b-e063-6294a90add15	2025-12-09		Exact identifier unii: 15FIX9V2JP
Sunscreen Plus Mineral Stick Untinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	3234b498-5b56-55f4-e063-6294a90a9b87	2025-12-09		Exact identifier unii: 15FIX9V2JP
Sunscreen Plus Mineral Stick Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Lily Lee, MD	32351db0-884c-8fa0-e063-6294a90acba2	2025-12-09		Exact identifier unii: 15FIX9V2JP
Sheer Satin Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	INTEGRATIVE AESTHETICS BOSTON, LLC	3143d8b0-4af8-f52d-e063-6294a90a926b	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Sheer Non-Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33d83cfb-045d-141c-e063-6394a90a2e04	2025-12-09		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b7584-c782-fe9e-e063-6394a90a76fe	2025-12-09		Exact identifier unii: 15FIX9V2JP
Transparent Tinted Mineral Sunscreen Stick	TITANIUM DIOXIDE, ZINC OXIDE	Face Collection, L.L.C.	33dbfd9b-b90f-bb32-e063-6294a90af7dc	2025-12-09		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Maloney Plastic Surgery Skin Care, PLLC	316b46ac-6dde-72d1-e063-6294a90a03da	2025-12-09		Exact identifier unii: 15FIX9V2JP
BIOJUVE Microbiome-Safe Sheer Finish SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ece7565b-f3e5-3386-e053-2a95a90a5802	2025-12-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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