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 101 of 116 · 2,303 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
Good Neighbor Pharmacy Artifical Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Proficient Rx LP	73e12596-6dd5-4cd2-83ed-992e1211b4b8	2023-12-01	Warnings	Exact identifier unii: FZ989GH94E
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
SOOTHE Daily Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	9acbf663-15e4-4572-a267-56afa58a347b	2023-11-30	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 60 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Derma Care Research Labs, LLC	0aae69f1-66bf-a199-e063-6394a90a3d75	2023-11-21	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a9c1b3f-656d-0d62-e063-6394a90a4731	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	581e8289-1406-45b6-9786-753800665fad	2023-11-20	Warnings	Exact identifier unii: 15FIX9V2JP
Rite Aid Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Rite Aid	0a4cea12-7e00-d201-e063-6394a90a6691	2023-11-16	Warnings	Exact identifier unii: 15FIX9V2JP
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	Laurus Labs Limited	1f8f9fe1-b8fd-4f65-8832-9d3d6802d076	2023-11-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I
Max Mineral	TITANIUM DIOXIDE, ZINC OXIDE	Peter Thomas Roth Labs, LLC	0980992c-6488-2fa1-e063-6294a90a41ea	2023-11-14	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands, SPF-50 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	493551d0-10a0-3d78-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	494a7886-d677-1648-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	ab691543-e37a-487a-912e-56d2e0e4d30a	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
PURE HAVEN BODY SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Pure haven, LLC	6f298fcd-8a97-8f66-e053-2991aa0adb10	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Sunstation All-Natural SPF 30 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunstation USA, LLC	499d366a-a7f1-6070-e054-00144ff88e88	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Pure Haven Essentials	TITANIUM DIOXIDE, ZINC OXIDE	Pure Haven LLC	4bccc017-266d-11ce-e054-00144ff8d46c	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Kapa'ihi, Inc	66e5eb1b-4ef0-459d-8428-b3e2f221bc85	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
YOU-V SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	YouV, LLC	290cd617-aa90-4f10-8a1d-d8954b927004	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30	TITANIUM DIOXIDE	Coral Reef Park Co., Inc.	743f3d23-0f5c-4724-9f69-411c109506e1	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
ONCODERM Rx Mineral Sunscreen SPF-30	TITANIUM DIOXIDE, ZINC OXIDE	Oncoderm, LLC	9f16e832-067c-4ae8-bd7d-6f0dc0ad6fae	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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