FDA.reportPublic FDA data

NDC 0069-0471-97 - CHANTIX

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
0069-0471
Requested NDC
0069-0471-97
Package NDCs from labels
0069-0471-03, 0069-0471-28, 0069-0471-97
Manufacturer
Pfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Italia S.r.l. | Pfizer Manufacturing Deutschland GmbH
Effective date
2026-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CHANTIXPfizer Laboratories Div Pfizer Inc | Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Italia S.r.l. | Pfizer Manufacturing Deutschland GmbH2026-01-23HUMAN PRESCRIPTION DRUG LABEL
CHANTIX - A-S Medication SolutionsA-S Medication Solutions2021-03-26HUMAN PRESCRIPTION DRUG LABEL
CHANTIX - Proficient Rx LPProficient Rx LP2020-02-01HUMAN PRESCRIPTION DRUG LABEL
ChantixPhysicians Total Care, Inc. | Pfizer Ireland Pharmaceuticals | Pfizer Manufacturing Deutschland GmbH | Pfizer Pharmaceuticals LLC2011-12-19HUMAN PRESCRIPTION DRUG LABEL
CHANTIX - Rebel Distributors CorpRebel Distributors Corp2011-07-20HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0069-0471-03CHANTIX1 in 1 CARTONKIT149
0069-0471-28CHANTIX1 in 1 BLISTER PACKKIT149

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0471CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]44Current NDC, Legacy NDC, 2 package rows20250110_f0ff4f27-5185-4881-a749-c6b7a0ca5696.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0471-02EA - Each0069-04712ae35096-914d-4dc4-bb61-9f58c5fdbdb012012-07-24
0069-0471-03EA - Each0069-047185bea58e-796c-401a-adf0-18a5b817f7f812015-07-20
0069-0471-28EA - Each0069-0471b88afdad-7159-410a-a696-0e37a58ef01012025-12-16
0069-0471-97EA - Each0069-04717ec42f76-1e24-45eb-8f16-57c68cccd4fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSEINACTIVE INGREDIENT029TFK992NCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
TRIACETININACTIVE INGREDIENTXHX3C3X673CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED CHANTIX (VARENICLINE TARTRATE) KIT [PFIZER LABORATORIES DIV PFIZER INC]28
VARENICLINE TARTRATEACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
VARENICLINEACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]2
varenicline tartrateACTIVE INGREDIENT82269ASB48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
vareniclineACTIVE MOIETYW6HS99O8ZOCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
anhydrous dibasic calcium phosphateINACTIVE INGREDIENTL11K75P92JCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CHANTIX (VARENICLINE TARTRATE) KIT CHANTIX (VARENICLINE TARTRATE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]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 5 of 135 · 2,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Varenicline tartrateVARENICLINE TARTRATEA-S Medication Solutionse10d320a-adf2-4f1d-a576-9685e45512302026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 636671
unii: 82269ASB48
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
VARENICLINEVARENICLINEA-S Medication Solutions8a06d177-0e62-457d-b0c8-47f60a313a1c2026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 636676
unii: 82269ASB48
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
VareniclineVARENICLINE TARTRATEAjanta Pharma USA Inc.2f86bb7b-c6a6-4915-8ba1-17251540971c2026-06-19Warnings, Adverse reactionsExact identifier
rxcui: 636676
rxcui: 749788
rxcui: 636671
rxcui: 749289
unii: 82269ASB48
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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