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 91 of 116 · 2,303 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PROCEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	0b62062d-b77e-4e6c-b3ab-b35ab24db7cb	2024-06-04	Warnings	Exact identifier unii: 15FIX9V2JP
Sterile Water	WATER	Becton Dickinson and Company	6e43c5a3-dad2-49ed-b500-964cb4563cc9	2024-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Protectif Deep Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Derma Research Group Inc.	19b19023-1340-6609-e063-6394a90a6eaf	2024-05-30	Warnings	Exact identifier unii: 15FIX9V2JP
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate	EFAVIRENZ, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Teva Pharmaceuticals USA, Inc.	fc9c2149-8d40-401b-af13-5ae7f953950a	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
COOLA Mineral Liplux Lip Balm SPF 30 Nude Beach	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee2842c3-65e0-3904-e053-2a95a90aabff	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Mineral Liplux Lip Balm SPF 30 Firecracker	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee026a1c-885b-256f-e053-2a95a90af564	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic SPF 50 Mineral Sunscreen Vanilla Coco	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ec96dee8-85e8-3147-e053-2995a90aaf53	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Bronze Goddess	TITANIUM DIOXIDE	COOLA, LLC	eeb406c6-a543-379a-e053-2995a90a4998	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
COOLA Rosilliance Mineral Tinted Face Moisturizer SPF 30 Fresh Rose	TITANIUM DIOXIDE	COOLA, LLC	ee01642f-478e-b307-e053-2a95a90a7d81	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Untinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ecabcc89-fb09-41a9-e053-2995a90a8b31	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Matte Tinted Face SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	ee018c21-dca7-28aa-e053-2a95a90a3bdb	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Golden Daze	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eeb70034-0f8d-a46d-e053-2a95a90a8130	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Bare Republic Mineral Shimmer SPF 30 Diamond Dust	TITANIUM DIOXIDE, ZINC OXIDE	COOLA, LLC	eec83ecb-d0ab-7857-e053-2995a90a40ed	2024-05-22	Warnings	Exact identifier unii: 15FIX9V2JP
Protective Tinted Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs LLC	18e1edd9-e39b-c91f-e063-6394a90a32a0	2024-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Sun Defense Moisturizer Broad Spectrum Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	June Jacobs Labs, LLC	18e4c50d-eb91-c269-e063-6394a90a7999	2024-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Untinted	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	18aa2604-c8f0-ca04-e063-6294a90a1c25	2024-05-17	Warnings	Exact identifier unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	A-S Medication Solutions	7bf86d9d-999a-4b64-849a-0d43bbf7b766	2024-05-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
Jack Black	TITANIUM DIOXIDE, ZINC OXIDE	Jack Black L.L.C	181d5bf3-ce91-cb2c-e063-6294a90a51c4	2024-05-10	Warnings	Exact identifier unii: 15FIX9V2JP
Protectif Fair Tint	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs	181e3f34-c5b2-0976-e063-6394a90a9a78	2024-05-10	Warnings	Exact identifier unii: 15FIX9V2JP
Emtricitabine and tenofovir disoproxil fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Zydus Pharmaceuticals USA Inc.	7def7a95-e69e-4985-974a-efacadcecc95	2024-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S

Reported adverse events (FAERS/openFDA)#

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