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 84 of 178 · 3,549 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
CVS Tropical FruitANTACIDCVS321fce7a-90be-45f2-b3a5-6b92d4f6ddb32025-12-04WarningsExact identifier
unii: H0G9379FGK
quitine mini nicotineNICOTINE POLACRILEXQUITINE LLC0781ddbd-45c4-4191-898a-50c71644965c2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE MINI NICOTINENICOTINE POLACRILEXQUITINE LLCd856379c-6334-4069-8382-ded2f86cf8a42025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
Quality Choice Chewable Antacid Assorted FruitANTACID TABLETSChain Drug Marketing Associationc1171d19-5694-4e6c-9865-40c5f62c4f052025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Antacid Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONbfb80841-edda-482b-b401-e5f1cd52440e2025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Regular Strength Peppermint FlavorCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONea1abf51-7d10-4b1f-8eca-c5f94892bfe72025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Regular StrengthANTACIDQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)1dd6df9a-241b-4a85-b31a-0741e916ae462025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Assorted Berries Extra StrengthCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATIONc7f26b0a-f2c4-4ed2-9673-52f90d1a41c92025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Extra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION639b39b5-44e0-4bba-8887-ce62cfac68372025-12-03WarningsExact identifier
unii: H0G9379FGK
QC Antacid Calcium Assorted BerryCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION INC.82f5e540-a1b2-48e2-9b1d-ff52c29f78352025-12-03WarningsExact identifier
unii: H0G9379FGK
Quality Choice Ultra Strength Assorted FruitCALCIUM CARBONATECHAIN DRUG MARKETING ASSOCIATION63318b46-d47d-474c-8fb5-5e0d53b7adb42025-12-03WarningsExact identifier
unii: H0G9379FGK
calcium antacidextra strength extra strengthCALCIUM CARBONATERugby Laboratoriesd761954f-940e-4833-87b7-173a921aade12025-12-03WarningsExact identifier
unii: H0G9379FGK
Equate Ultra Stregth AntacidCALCIUM CARBONATEWal-Mart Stores, Inc.cdfe5c95-3f90-4620-a618-18bac0471c3e2025-12-03WarningsExact identifier
unii: H0G9379FGK
NWRB Nicotine Transdermal PatchNICOTINEDongkou County Hecheng Network Technology Co., Ltd.44f3e697-1859-dab0-e063-6294a90a45172025-12-02WarningsExact identifier
unii: 6M3C89ZY6R
D-CALCALCIUM CARBONATEA&Z Pharmaceutical Inc.4c202dae-1ad8-44ab-a272-bdca808453022025-12-01WarningsExact identifier
unii: H0G9379FGK
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
Antacid Regular StrengthANTACIDWALGREEN CO.ce5eef7f-497d-4c88-be6a-17eeb6e07f5b2025-11-25WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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