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 24 of 181 · 3,616 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATETWIN MED LLC0f867f56-4bc0-4a85-b9d2-a16282b7c82b2026-05-01WarningsExact identifier
unii: 8MDF5V39QO
Blue Lizard Sport SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratories4955fa1c-789d-4f42-af75-70223310644a2026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Blue Lizard Kids SPF 50 SunscreenOCTISALATE AND TITANIUM DIOXIDE AND ZINC OXIDECrown Laboratoriesba4ae906-48c0-8384-e053-2995a90afb912026-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dior Backstage Glow-Up Skin Tint Tinted Moisturizer SPF 20 2CR Cool RosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6831832a-e52e-43ea-899f-f5d44bea5a942026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
Nicotine PolacrilexNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdb765570e-e5b5-48e4-b4d2-2a85ac19a2ea2026-04-30WarningsExact identifier
unii: 6M3C89ZY6R
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC0f1b3cc6-98df-4e34-91f3-dc251fe170f82026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporation9d315243-b55e-4277-b0c2-83e7b5fe504c2026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporatione808dd98-3307-4dcf-b042-910ea6c3170a2026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
NicotineNICOTINE POLACRILEXRite Aid Corporationb5d5bdb5-8961-4c8a-9f58-4f23044264a62026-04-28WarningsExact identifier
application number: ANDA076777
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporationdc4d4fe1-6a60-4f02-b04f-a500e22d25da2026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company59afdc0a-5e45-4cca-abef-4415c170a19a2026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Company7446369d-2fac-4c5a-a6bb-9e149abc4c152026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporation1c49ddd3-0f2c-4310-acf1-edd42e3aafc52026-04-28WarningsExact identifier
unii: 6M3C89ZY6R
FolyraMULTIVITAMINOncora Pharma, LLCcb182e26-17c5-4d00-869f-08823afeeee82026-04-28Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
up and up coated cool mint nicotineNICOTINE POLACRILEXTarget Corporation7b5e2b0d-0c29-4cdf-acb0-a202bdb7463c2026-04-27WarningsExact identifier
application number: ANDA076777
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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