FDA.reportPublic FDA data

NDC 59779-957-01 - Nicotine

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
59779-957
Requested NDC
59779-957-01
Package NDCs from labels
59779-957-01, 59779-957-02, 59779-957-52, 59779-957-60, 59779-957-04
Manufacturer
CVS Pharmacy
Effective date
2026-04-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine - CVS PharmacyCVS Pharmacy2026-04-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-957-01Nicotine27 in 1 CONTAINERLOZENGE278
59779-957-02Nicotine3 in 1 CARTONLOZENGE38
59779-957-04Nicotine5 in 1 CARTONLOZENGE58
59779-957-52Nicotine10 in 1 CONTAINERLOZENGE108
59779-957-52Nicotine1 in 1 CARTONLOZENGE18
59779-957-60Nicotine1 in 1 CARTONLOZENGE18
59779-957-60Nicotine20 in 1 CONTAINERLOZENGE208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-957NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]7Current NDC, Legacy NDC, 7 package rows20230106_54b181ea-41fc-46b6-9611-5473973c82d9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59779-957-04EA - Each59779-957fc56b73e-c879-4b9b-9005-cf1ea0e2285412019-08-06
59779-957-60EA - Each59779-957e6de320c-f7e8-439f-85df-6d94cb3e882d12020-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
NICOTINEACTIVE MOIETY6M3C89ZY6RNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4NICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICOTINE (NICOTINE POLACRILEX) LOZENGE [CVS PHARMACY]4

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 23 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.a3f19365-d0d1-43ad-be15-48dc4320e3612025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.e86b9c22-7ee0-4bd0-adfd-a7b087b1dd712025-12-06WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: HM5Z15LEBN
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
quitine mini nicotineNICOTINE POLACRILEXQUITINE LLC0781ddbd-45c4-4191-898a-50c71644965c2025-12-04WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
QUITINE MINI NICOTINENICOTINE POLACRILEXQUITINE LLCd856379c-6334-4069-8382-ded2f86cf8a42025-12-04WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
unii: 8F049NKY49
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
unii: 8F049NKY49
NWRB Nicotine Transdermal PatchNICOTINEDongkou County Hecheng Network Technology Co., Ltd.44f3e697-1859-dab0-e063-6294a90a45172025-12-02WarningsExact identifier
unii: 6M3C89ZY6R
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
unii: 8F049NKY49
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
unii: 8F049NKY49
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
unii: 8F049NKY49
NicDuic Quit Smoking Nicotine Patches 3 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.4429fea8-46f8-8f7f-e063-6394a90a34b42025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 2 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442a926b-d7c1-4e35-e063-6394a90ad9482025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 1 StepNICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442aae32-4ac6-5dd6-e063-6294a90aad022025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
NicDuic Quit Smoking Nicotine Patches 1-3 Step21MG NICOTINE PATCHESShenzhen Paxi Trading Co., Ltd.442ae0fa-a1ed-7901-e063-6294a90ab7172025-11-22WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWALMART INC.a4540259-78c1-4da2-a465-8a4cfe29a2902025-11-19WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWALMART INC.86c2cac9-4b7b-4b80-9ca1-32634304449e2025-11-19WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company477689fc-688a-4c76-8c02-35a7a15adc5e2025-11-19WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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