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 61 of 179 · 3,563 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC472f34c5-cefe-4884-9475-fd0666c925ac2025-12-18WarningsExact identifier
unii: 15FIX9V2JP
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: VCQ006KQ1E
unii: 506T60A25R
Sunscreen Lotion118mlZINC OXIDE 12%,TITANIUM DIOXIDE 6%, HOMOSALATE 14%,OCTISALATE 5%Foshan Sugar Max Cosmetics CO.,Ltd4620c41a-2188-00f5-e063-6394a90a613c2025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen CreamZINC OXIDE 15%,TITANIUM DIOXIDE 6%,HOMOSALATE 5%,OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46224dbe-a0fb-c242-e063-6394a90a26342025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Antacid Regular strengthANTACID TABLETSWALGREEN CO.9090e2c0-4837-44ea-b6c4-f46532eadee12025-12-17WarningsExact identifier
unii: H0G9379FGK
Perricone High Potency Face Finishing and Firming MoisturizerTITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC2409cea1-7077-dc12-e063-6294a90a45582025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC3635a073-5484-f96c-e063-6394a90adef52025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen LipTITANIUM DIOXIDE, ZINC OXIDEGlow Advanced Skin and Body Care, LLC36362dc7-31d7-f766-e063-6294a90a129b2025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski36480f7f-37e8-decd-e063-6394a90ada602025-12-17Exact identifier
unii: 15FIX9V2JP
Prime and ProtectTITANIUM DIOXIDE, ZINC OXIDEShannon Cornelsen-Lewandowski364827bd-5781-eb53-e063-6394a90ab22f2025-12-17Exact identifier
unii: 15FIX9V2JP
non-tinted face mineral sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649bf1a-17c3-fe0b-e063-6294a90a13c02025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mattifying Face Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing3649f634-8bcd-b3c1-e063-6394a90a49d92025-12-17Exact identifier
unii: 15FIX9V2JP
tinted lip mineral sunscreen SPF45TITANIUM DIOXIDE, ZINC OXIDELisa Nadler Skin Care and Waxing364b023b-4a52-225a-e063-6394a90ad1972025-12-17Exact identifier
unii: 15FIX9V2JP
ULTAMATTE PROTECTION SUNSCREENTITANIUM DIOXIDE, ZINC OXIDESKINFINITY37efc466-17b8-9f7b-e063-6294a90a8c882025-12-17Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3cce3120-748e-a7fd-e063-6394a90a4d512025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY MINDY LLC3d5a2662-02e3-3a95-e063-6294a90a81202025-12-17WarningsExact identifier
unii: 15FIX9V2JP
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEJKH Aesthetics LLC369ccb8f-d9b6-1fd2-e063-6394a90ace202025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d4f6a7-1115-1efa-e063-6294a90a20c42025-12-17Exact identifier
unii: 15FIX9V2JP
Mattifying Mineral SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDEELIZA ARAKELIAN36d45700-fc41-ef54-e063-6394a90abcc32025-12-17Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEHSC MIAMI, INC36d85902-fbd2-ba74-e063-6294a90acfc32025-12-17Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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