FDA.reportPublic FDA data

NDC 49348-787-59 - Sunmark 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
49348-787
Requested NDC
49348-787-59
Package NDCs from labels
49348-787-10, 49348-787-59
Manufacturer
Strategic Sourcing Services LLC
Effective date
2024-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunmark Nicotine - Strategic Sourcing Services LLCStrategic Sourcing Services LLC2024-12-23HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-11Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-787SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [STRATEGIC SOURCING SERVICES LLC]11Legacy NDC20241225_d3ed13e9-4616-4d88-a376-760ae1789881.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-787-10EA - Each49348-787ca4f87e2-61ad-4f91-8c26-519f43aa89e912012-07-24
49348-787-59EA - Each49348-787e07ebaaa-7bae-4971-b629-6ca813481b0f12013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
NICOTINEACTIVE MOIETY6M3C89ZY6RSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9SUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
GELATININACTIVE INGREDIENT2G86QN327LSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
MANNITOLINACTIVE INGREDIENT3OWL53L36ASUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
POLACRILININACTIVE INGREDIENTRCZ785HI7SSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
SORBITOLINACTIVE INGREDIENT506T60A25RSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
TALCINACTIVE INGREDIENT7SEV7J4R1USUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]4
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ESUNMARK NICOTINE (NICOTINE POLACRILEX) GUM, CHEWING [MCKESSON]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 35 of 179 · 3,563 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cle de peau BEAUTE RADIANT FLUID FOUNDATION NATURAL B50OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION4490f968-46b6-44d2-af2d-5130b52c88612026-03-05WarningsExact identifier
unii: 15FIX9V2JP
PneumoforceALTHAEA OFFICINALIS, NATRUM CARBONICUM, RHEUM (PALMATUM), VERBASCUM THAPSUS, ZINGIBER OFFICINALE, ACONITUM NAPELLUS, DROSERA (ROTUNDIFOLIA), KALI BICHROMICUM, LOBELIA INFLATA, PHOSPHORUSBioActive Nutritional, Inc.a58c6a1a-ad3e-4055-8077-b6738105087d2026-03-05WarningsExact identifier
unii: 45P3261C7T
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: 45P3261C7T
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc049d2c75-9b7f-4248-81e9-e2973a4cab5d2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWalgreen Company6f1dcfda-c12a-4c3b-80a2-c9e15517c88f2026-03-03WarningsExact identifier
unii: H0G9379FGK
SEYIPCALCIUM CARBONATESeaip co., Ltdd98d8626-8c42-77a5-e053-2a95a90a78e22026-03-03WarningsExact identifier
unii: H0G9379FGK
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E B85e3a322-e1a2-4f8e-a616-b279ad1bcefe2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Companye5a8974f-d402-4390-8b80-b896b094a0592026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEH E Bbe4a13e4-9938-4223-bcc1-4f5d969728132026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E B1fb02f5e-56af-47ef-a1bc-49a6d86cc70c2026-03-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companydc1ffb6b-0865-4854-bbbd-97606995e3f42026-03-02WarningsExact identifier
application number: ANDA076777
unii: 6M3C89ZY6R
Nova AntacidCALCIUM CARBONATEBlueberri Inc.48696198-fc2b-eb24-e063-6294a90a3eae2026-03-02WarningsExact identifier
unii: H0G9379FGK
REGULAR STRENGTH ANTACID PEPPERMINTCALCIUM CARBONATEAKRON PHARMA INC3fb78d78-5296-4197-e063-6294a90adaae2026-03-02WarningsExact identifier
unii: H0G9379FGK
BLIPNICOTINE POLACRILEXBlip Products, Inc.291649cf-e5a6-4a98-9a9e-c499b55c37ae2026-03-02WarningsExact identifier
unii: 6M3C89ZY6R
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: 45P3261C7T
NICOTINENICOTINE POLACRILEXWalgreen Company97fefc42-5c9d-453e-a0b6-dc7aac5ee8e12026-03-02WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Company74f306d4-2a71-48c9-ab98-378260507a9d2026-03-01WarningsExact identifier
unii: 6M3C89ZY6R
Sodium Bicarbonate 5 grSODIUM BICARBONATETWIN MED LLC12cad432-99db-4a9b-8619-82794e29409e2026-03-01WarningsExact identifier
unii: 8MDF5V39QO
Rugby Nicotine Polacrilex Gum, Coated Fruit FlavorNICOTINE POLACRILEXRugby Laboratoriesb973d045-7791-49c1-9216-4e0d511737352026-02-27WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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