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 82 of 116 · 2,303 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MD Restoring daily Defense Moisturizer SPF 50	ZINC OXIDE AND TITANIUM DIOXIDE	Allure Labs Inc	eb8e7109-b5eb-5cc1-e053-2995a90a486f	2024-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Quench and Protect Hydrating SPF30	ZINC DIOXIDE AND TITANIUM DIOXIDE	Allure Labs.	039e50c1-7b3d-d392-e063-6394a90a4b3c	2024-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Derm Institute Daily Defense Protection Sunscreen Broad Spectrum SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Beautcella Inc.	bad942d8-04da-31d2-e053-2a95a90a9275	2024-12-06	Warnings	Exact identifier unii: 15FIX9V2JP
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Cipla USA Inc.	d08c9455-e788-435c-9076-2bdb1a4f5b37	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
MISSHA M Perfect Cover BB Cream SPF42 (No. 25)	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	604e7a49-7986-11ee-e053-2a91aa0a1bee	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 27	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	c4e16cec-c7db-4e5e-9d05-5d7afdb79091	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No29	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3fc90114-4cdf-273e-e054-00144ff8d46c	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 31	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95862d15-d977-7276-e053-2995a90ab690	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB Cream SPF42 No. 25	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9c6f48b1-007b-434f-b756-242e3390e9b7	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA ALL AROUND VITA C SUNSCREEN	ZINC OXIDE, HOMOSALATE, ETHYLHEXYL SALICYLATE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	1a7ec673-328a-8924-e063-6294a90a2f3d	2024-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
EGF FGF DNA UV SHIELD	ETHYLHEXYL METHOXYCINNAMATE, TITANIUM DIOXIDE, ETHYLHEXYL SALICYLATE	Dermaesthetics Inc.	13e2630d-9915-4287-91fd-deb672150131	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 13	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	95846b5e-5b72-26bc-e053-2a95a90ae0f7	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 21	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	9585d3d2-806c-36e3-e053-2a95a90a28fa	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB SPF42 No21	OCTINOXATE, ZINC OXIDE, TITANIUM DIOXIDE	Able C&C Co., Ltd.	3d196cf3-eddd-21d7-e054-00144ff88e88	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
MISSHA M Perfect Cover BB No 23	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE	Able C&C Co., Ltd.	6a81522e-f4d9-4013-8563-f50f01ff6326	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
LBEL FOREVER STAY POLVOS COMPACTOS DE LARGA DURACION FPS 15 LONG LASTING COMPACT SPF 15 PERLA 100	TITANIUM DIOXIDE, ZINC OXIDE	BEL STAR S A	e4bb5a32-c5dc-86d5-e053-2a95a90a4938	2024-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Moisture Matte Broad Spectrum SPF 40 Sunscreen Amber	ZINC OXIDE, TITANIUM DIOXIDE	Alumier Labs	ba864a08-e66d-d286-e053-2995a90a1854	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	2874e531-d647-339c-e063-6394a90ac86f	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
Alumier MD Sheer Hydration Tinted Moisturizing Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Alumier Labs	a951ebe7-7786-38ef-e053-2995a90a70e3	2024-12-03	Warnings	Exact identifier unii: 15FIX9V2JP
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50	ZINC OXIDE, TITANIUM DIOXIDE	Expanscience Laboratories d/b/a Mustela	beec926c-35a5-1901-e053-2a95a90ad043	2024-12-02	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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