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 64 of 116 · 2,315 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 29C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	15536331-fec5-4daa-824d-2e32d63e6452	2025-08-12	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 22N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ad8afa83-2844-422c-b2bf-b5a61be368b1	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 23W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	96973dee-681b-4c5d-b31f-de05cd79fa18	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 24N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ecda3658-eca1-48c2-9eff-e22fd1ff70df	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 25W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c6f27df4-6de4-45e4-90cb-ea8b0d29dbd3	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 26W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	968abacd-8b99-4529-a627-2b56cdf99e1b	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 27N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	a9068dc0-bc48-498b-adc9-57ff810384af	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 28W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37f01f66-c604-4fc3-a263-2089db91283f	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 29W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	bca57893-bd2d-44ac-a503-2f11c3b62bf2	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 30N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	37188b77-ab0b-4bea-b839-99e589600a2b	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 31N Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c89e45d6-2322-4913-a557-e1780a86fd63	2025-08-11	Warnings	Exact identifier unii: 15FIX9V2JP
SUNSCREEN SPF50	ETHYLHEXYL METHOXYCINNAMATE, OCTOCRYLENE, TITANIUM DIOXIDE	Guangzhou Tinsun Biotechnology Company Limited	3bc1c6e9-1dd5-d7c6-e063-6394a90ad89e	2025-08-07	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 17W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	053cb3cd-dd16-4d08-b347-a4349fa37c07	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 14W Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	7bf90657-b636-41d6-b96c-88d174989f5b	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 15N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	da7e19cd-6a8b-47df-bfc9-2f0f11b7955c	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 16N Light Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	f7a1d379-6de0-4be4-84a9-e0ebef332bef	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 18N Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	671be8a6-51b7-45d2-9fff-c7736d2eea3e	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 19W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9efa5db5-d774-4089-895c-9667eda0f11b	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 20C Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	76232666-e23f-4842-bd0d-37819739ec3a	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 21W Medium	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	876b9a5d-dae3-47f1-9da6-b5e179fd28cd	2025-08-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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