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 45 of 116 · 2,315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Facial Protection SPF40	TITANIUM DIOXIDE, ZINC OXIDE	FRESH FACED SKIN CARE LLC	35d08e2a-b118-8634-e063-6294a90a918d	2025-12-11		Exact identifier unii: 15FIX9V2JP
Anti-Aging Sun Protection NT	TITANIUM DIOXIDE, ZINC OXIDE	DERMOPERFECTION SKINCARE SERVICES, LLC	351a20df-bd8a-8ea6-e063-6294a90abaaf	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Primer Anti-Aging	TITANIUM DIOXIDE, ZINC OXIDE	DERMOPERFECTION SKINCARE SERVICES, LLC	351aaaad-44ce-3558-e063-6294a90a2b46	2025-12-11		Exact identifier unii: 15FIX9V2JP
Daily Shield Facial Primer	TITANIUM DIOXIDE, ZINC OXIDE	Skintique	37dd5228-5fe4-5e7b-e063-6294a90adffb	2025-12-11		Exact identifier unii: 15FIX9V2JP
Daily Shield Facial Primer	TITANIUM DIOXIDE, ZINC OXIDE	Skintique	37de2f44-e0da-0d1c-e063-6294a90ae18b	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	LEILANI VIDAL	36d5831a-7128-729a-e063-6394a90a8036	2025-12-11		Exact identifier unii: 15FIX9V2JP
Mineral Matte Non-Tinted Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac219bd-dfc8-fe22-e063-6394a90a4a8c	2025-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Facial Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac25d06-d885-48a2-e063-6294a90a0d0b	2025-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	ORAIOS BEAUTY LLC	3ac27b6c-1341-1f05-e063-6394a90a9860	2025-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	37287e4c-6fdf-62c5-e063-6394a90a1296	2025-12-11		Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen Non Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	37284de3-32d4-3611-e063-6394a90a6393	2025-12-11		Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	DR. CARIN GRIBETZ BOARD CERTIFIED DERMATOLOGIST	3728ec6a-7de5-bbc5-e063-6294a90a31b7	2025-12-11		Exact identifier unii: 15FIX9V2JP
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db5721-2b32-d4d8-e063-6294a90a47d7	2025-12-11		Exact identifier unii: 15FIX9V2JP
SUNerchi Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	SYNERCHI MED SPA, INC.	37db14e1-f995-b649-e063-6294a90afd69	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351d27e3-00d4-8d31-e063-6394a90aaf72	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Saving Face Skinspa Inc.	351db99e-262f-b67e-e063-6394a90a3418	2025-12-11		Exact identifier unii: 15FIX9V2JP
Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DAISY'S SKIN TRANSFORMATION LLC	37d9fbf5-d602-d3dc-e063-6394a90abe53	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374d53a7-be0b-4d7a-e063-6394a90a37c4	2025-12-11		Exact identifier unii: 15FIX9V2JP
Tinted Mineral 40	TITANIUM DIOXIDE, ZINC OXIDE	2301 PLASTIC SURGERY, PLLC	374df66d-eb9b-c4a7-e063-6394a90a3cc6	2025-12-11		Exact identifier unii: 15FIX9V2JP
Facial Mineral Sunscreen Mineral Protection	TITANIUM DIOXIDE, ZINC OXIDE	CAPE COD SKIN CARE CO. INC.	387f6dd5-3901-0849-e063-6294a90af8bc	2025-12-11		Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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