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 18 of 118 · 2,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1aae19da-1e73-41ed-91dc-0746ad311b87	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	22d4452d-3798-48c6-a7a4-4af0f99b4ebd	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d6800bb7-16ef-48f6-a09a-0422e64ad8bd	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	fb9cfd4f-a558-4df2-bbbf-b814ae19a135	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b9ddcda6-3d87-4197-a2c2-5b30016d32eb	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	25abef37-1726-491f-8a11-ac1a96378ed1	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b0e315b3-a322-4607-b212-bcadd5aa99bc	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cc0f19fc-7b6f-4454-9a77-dc11f0fd1251	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c361a514-5fc9-42a7-b1fc-28e4a11ad733	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	db38ced5-dfbe-4b7e-b4ae-3065df1898b0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ead1ce8-f31d-4676-8619-8d49dd62db2e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	827caf09-222e-487a-941c-44eb5c13d5d6	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f3c378e1-853b-463e-9fc3-6a54ef861044	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3a479c4-807e-4c52-a27f-eea8705b9c1e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cb63faaa-82d8-469a-a9a1-88b09e02cc35	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c20b0b8b-366a-47ff-84b6-264fa8ed6de0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31d89246-418d-4ed4-8e32-7aa2422073a9	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31b74e11-c5e5-4086-baa5-e7a39dc556a0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	29ec217b-7726-4590-8a0d-e4b08217e222	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ceabea37-020c-49e0-a049-3100ed46ff57	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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