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 29 of 39 · 770 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack094de23b-d433-487d-8364-6f245c8117c62025-04-03WarningsExact identifier
application number: ANDA203690
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack3997dda6-89ea-49df-abda-ab420327a4732025-04-03WarningsExact identifier
application number: ANDA203690
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXPLD Acquisitions LLC DBA Avma Pharma Solutions71db232e-b169-47d0-b269-5e14fa75f3a22025-03-27WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
SEFUDUN QUIT SMOKING NICOTINE PATCHESNICOTINEShenzhen Shandian Jingling Technology Co., Ltd.314e6f25-8fd0-38ba-e063-6294a90aca8b2025-03-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMWalgreens5aadb95f-428c-b637-01f4-50d5866ced0c2025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD313b08e2-d764-96da-e063-6294a90ab7052025-03-25WarningsExact identifier
unii: 6M3C89ZY6R
HypothaltemEUPATORIUM PERFOLIATUM, BERBERIS VULGARIS, MENTHA PULEGIUM, MOSCHUS, BENZINUM, SEPIA, BARYTA CARBONICA, GLANDULA SUPRARENALIS SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, THYROIDINUM (SUIS), PYRIDOXINUM HYDROCHLORICUM, GELSEMIUM SEMPERVIRENS, NATRUM CARBONICUM, NUX VOMICA, STAPHYSAGRIANucleic Products, LLCb95050f2-f40d-4e84-8752-4d7ad75390c92025-03-20WarningsExact identifier
unii: 45P3261C7T
nicotineNICOTINE POLACRILEXWalgreen Company4a81d378-009d-43a9-a895-e371ffa700e92025-03-19WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD30a977c3-6862-670e-e063-6294a90aeb2f2025-03-18WarningsExact identifier
unii: 6M3C89ZY6R
BLIPNICOTINE POLACRILEXBlip Products, Inc.2f829466-f2fb-43f1-9e82-0d33b50b913a2025-03-17WarningsExact identifier
unii: 6M3C89ZY6R
Aspartame/MSG DetoxCHELIDONIUM MAJUS, ARNICA MONTANA, PHYTOLACCA DECANDRA, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BISPHENOL A (BPA), DEXTROSE, MALTODEXTRIN, SUCRALOSE, ASPARTIC ACID, DIKETOPIPERAZINE, DOPAMINE HYDROCHLORIDE, FORMALINUM, FORMICUM ACIDUM, L-PHENYLALANINE, METHYL ALCOHOL, MONOSODIUM GLUTAMATEDeseret Biologicals, Inc.a1dc1bf3-db71-4550-a975-4f146fb940052025-03-11WarningsExact identifier
unii: 96K6UQ3ZD4
NicotineNICOTINE POLACRILEXMcKesson Corporation dba SKY Packaging0b6880c8-04e7-418a-98d1-0c7d19e025b32025-03-06WarningsExact identifier
unii: 6M3C89ZY6R
Bestmade Natural Products BM212ARS ALB, KALI PHOS, NAT CARB, NITRIC ACIDBestmade Natural Products2f37416e-b3af-f980-e063-6294a90a6be12025-02-28WarningsExact identifier
unii: 45P3261C7T
Fiber laxativeCALCIUM POLYCARBOPHILDiscount Drug Mart, Inc2e0c4736-3d27-e088-e063-6294a90aeca82025-02-27WarningsExact identifier
unii: 8F049NKY49
Maxi NicotineNICOTINE POLACRILEXCardinal Health (Leader) 70000362b4a04-4a5f-4af6-9cd7-82aa172b7afb2025-02-26WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.8c81c885-1d56-4dca-b9bc-adfc9bf580512025-02-25WarningsExact identifier
unii: 6M3C89ZY6R
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: 45P3261C7T
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: 45P3261C7T
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: 6M3C89ZY6R
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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