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 6 of 181 · 3,616 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC4f3a02aa-6534-464e-b1ab-ea8e67a0a77b2026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Regular strengthCALCIUM CARBONATEWINCO FOODS, LLC3836cb06-7f1a-4cc9-bc03-eb13def449462026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLCef9ecb48-b394-4a85-8ba8-aa397d20cd842026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Extra StrengthCALCIUM CARBONATEWINCO FOODS, LLC49bd9752-ddfd-4cb1-bef6-22b4e5b95a372026-08-07WarningsExact identifier
unii: H0G9379FGK
WinCo FOODS Antacid Ultra StrengthCALCIUM CARBONATEWINCO FOODS, LLC1858cf76-cf36-4c56-9e15-14db609aa10f2026-08-07WarningsExact identifier
unii: H0G9379FGK
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC4cc32b8c-6316-4d4b-8fa9-ef640464ca692026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Oneoo Nicotine Gum (Mint)NICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.54b1329b-b422-29a5-e063-6294a90a87802026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXP & L Development, LLC3623455a-3f00-41d3-b17e-86a016da70472026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC10e3e1ac-2f78-4ce4-8f38-a283fac996602026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecd78195-2df2-401d-b590-2c1cb764df5c2026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDecf97d6b-6ca7-48c1-8c37-029421689cc12026-08-05WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacycb9189d6-0593-426d-8ff5-357a4c9180f62026-08-05WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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