FDA.reportPublic FDA data

NDC 51167-545 - Trikafta

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
51167-545
Package NDCs from labels
51167-545-07
Manufacturer
Vertex Pharmaceuticals Incorporated | AndersonBrecon Inc. | Shanghai SynTheAll Pharmaceutical, Co., Ltd. | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Pharmaceutical Manufacturing Research Services, Inc. | Almac Pharma Services LLC
Effective date
2026-06-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
TrikaftaVertex Pharmaceuticals Incorporated | AndersonBrecon Inc. | Shanghai SynTheAll Pharmaceutical, Co., Ltd. | F.I.S. Fabbrica Italiana Sintetici S.P.A. | Pharmaceutical Manufacturing Research Services, Inc. | Almac Pharma Services LLC2026-06-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51167-545-07Trikafta1 in 1 PACKETGRANULE780 mg22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51167-545TRIKAFTA (ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR) KIT [VERTEX PHARMACEUTICALS INCORPORATED]20Unmatched20250215_f354423a-85c2-41c3-a9db-0f3aee135d8d.zip

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 30 of 150 · 2,995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorb9fa3bb9-12ec-40d8-b433-a96d9d00cc902026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf7b2e348-2c7f-4ff5-8ab0-a3475c9d1f262026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior69924eb8-a8ca-4ea0-b087-c865a6a1313f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior5cafac21-fb2d-4d63-a7fe-01bf53b941e82026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorbfc27e8d-e59b-46f7-aec9-2a96a00a7c1c2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior8fd56c86-ef37-4f31-87d1-6283a19c84242026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4C CoolOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior91b62ba7-2deb-47e6-b9af-25bb459b4d752026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 3WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6eec7554-38ed-48d4-916d-ab3660fbf7032026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior939e6d5c-3dd7-4b01-af18-697dc4ba2d992026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4,5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior7149784b-3548-4643-abf6-58fde237bb982026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior061181d8-5387-4541-a7d7-426cba5997a02026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WO Warm OliveOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6ad554a-4795-4149-b066-c53a0989470e2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior58efeaaf-d3c6-44e9-b60f-8f22f5bb1d332026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Wear Flawless Skin True Foundation SPF 20 4WP Warm PeachOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf6b4a90b-5905-4f62-9e35-f2b1dda8dddd2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Berberis QuartzBERBERIS QUARTZUriel Pharmacy Inc.5da48d70-1140-495d-b672-0e55c04196e12026-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
BRUSH and GO SPF 50 ALL SKIN TYPES BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd0d9f132c-7630-4261-a0f8-fc7a4377731f2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
BRUSH and GO SPF 50 OILY/PROBLEMATIC SKIN BROAD SPECTRUMTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdf292da7d-ffd2-41c3-9a64-619aab19ff182026-01-15WarningsExact identifier
unii: 15FIX9V2JP
Multivit Sun ProtectorTITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltdabdb560d-29be-41dc-ad23-54ea571acb142026-01-15WarningsExact identifier
unii: 15FIX9V2JP
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
unii: 15FIX9V2JP
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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