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 9 of 118 · 2,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	53a79ee7-312b-49a2-8a9b-c50794fcd171	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Port Jervis Laboratories, Inc	51169bed-2091-ad2b-e063-6294a90a84b6	2026-05-05	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - FAIR	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	8cfb1f8c-1bd7-4983-ab82-1c9bd8925afa	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - DEEP	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	930bd1de-5a0e-4607-8d3c-b1ca918f890b	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - MEDIUM	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	0206c676-c24d-470e-adb2-7cb3173f3727	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
LUMINOUS EYE CORRECTOR SPF 41 - TAN	TITANIUM DIOXIDE, ZINC OXIDE	Drmtlgy, LLC	5c5aad09-9f93-4634-8db1-c67570b38b2b	2026-05-04	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Sport SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	4955fa1c-789d-4f42-af75-70223310644a	2026-05-01	Warnings	Exact identifier unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 Sunscreen	OCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDE	Crown Laboratories	ba4ae906-48c0-8384-e053-2995a90afb91	2026-05-01	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool Rosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6831832a-e52e-43ea-899f-f5d44bea5a94	2026-04-30	Warnings	Exact identifier unii: 15FIX9V2JP
Tru Skin Rituals SPF 25	TITANIUM DIOXIDE, ZINC OXIDE	Spa de Soleil	f725cd5c-999e-2393-e053-6394a90a09dc	2026-04-30	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509cad98-0321-2a0a-e063-6294a90a6ea9	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	509d7206-0cc1-c997-e063-6294a90a89e0	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
iVIZIA Lubricant Eye Gel	POVIDONE	Thea Pharma Inc.	1f06ca1a-5270-9a82-e063-6294a90aed64	2026-04-29	Warnings	Exact identifier unii: FZ989GH94E
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREEN	HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE	GPNY CORP	211dea04-faad-8ffc-e063-6294a90a8d68	2026-04-29	Warnings	Exact identifier unii: 15FIX9V2JP
GoodSense Eye Drops Advanced Relief Moisturizer	DEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCL	Preferred PHarmaceuticals Inc.	011473a8-26d5-4661-b3c0-745f9b6aa1d8	2026-04-29	Warnings	Exact identifier unii: FZ989GH94E
Anything SPF	OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE	Anything SPF LLC	508b8dcb-6600-6dad-e063-6294a90a565a	2026-04-28	Warnings	Exact identifier unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	4fe04c4b-2751-0561-e063-6394a90af768	2026-04-22	Warnings	Exact identifier unii: 15FIX9V2JP
Lazy Face SPF 30 Facescreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunny Day Creations	500ee303-7302-68d5-e063-6394a90ac6d4	2026-04-22	Warnings	Exact identifier unii: 15FIX9V2JP
Caldesene Baby	STARCH, CORN AND ZINC OXIDE	Insight Pharmaceuticals LLC	9f12dee2-7afa-45e9-a729-0fd42bb77715	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ
Caldesene Medicated Protecting	CORNSTARCH AND ZINC OXIDE	Insight Pharmaceuticals LLC	ffc92a0f-a7cf-4a46-b2f1-089df2bbb96b	2026-04-22	Warnings	Exact identifier unii: O8232NY3SJ

Reported adverse events (FAERS/openFDA)#

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