FDA.reportPublic FDA data

NDC 70000-0348-01 - Nicotine Polacrilex Coated Ice Mint

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
70000-0348
Requested NDC
70000-0348-01
Package NDCs from labels
70000-0348-1, 70000-0348-2, 70000-0348-01
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Coated Ice Mint - CARDINAL HEALTH 110, LLC. DBA LEADER 70000CARDINAL HEALTH 110, LLC. DBA LEADER 700002026-04-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0348-1Nicotine PolacrilexCoated Ice Mint20 in 1 CARTONGUM, CHEWING2025
70000-0348-1Nicotine PolacrilexCoated Ice Mint1 in 1 BLISTER PACKGUM, CHEWING125
70000-0348-2Nicotine PolacrilexCoated Ice Mint100 in 1 CARTONGUM, CHEWING10025
70000-0348-2Nicotine PolacrilexCoated Ice Mint1 in 1 BLISTER PACKGUM, CHEWING125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0348NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]23Current NDC, Legacy NDC, 4 package rows20241122_b075c3cb-d610-4a9c-8cf0-e4b9001bc86a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0348-1EA - Each70000-034887d8a12d-3cbe-4deb-acb3-7323b2a029b612019-02-13
70000-0348-2EA - Each70000-0348d6d02b52-9395-41d9-9909-59e1044838dc12018-11-06

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 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
CareOne NicotineNICOTINE POLACRILEXAmerican Sales Company74ec6a60-eb3a-47d4-a11b-650b6418d37f2026-04-14WarningsExact identifier
unii: 6M3C89ZY6R
up and up cherry ice nicotineNICOTINE POLACRILEXTarget Corporation99977d30-41ba-4237-920a-dbd5ad8fc3802026-04-14WarningsExact identifier
unii: 6M3C89ZY6R
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PRENATE EnhanceASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLCcf10de09-6ed5-4a66-84fa-2da4f668bbe62026-04-14Boxed warning, Adverse reactionsExact identifier
unii: 3A3U0GI71G
nicotineNICOTINE POLACRILEXMeijer, Inc.34107c14-6ece-4a51-b53f-ee0099889e992026-04-14WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Sodium Bicarbonate 10 gr. (650 mg)SODIUM BICARBONATEGendose Pharmaceuticals, LLC0a0cc46d-372e-4175-932a-065e82d8d3532026-04-13WarningsExact identifier
unii: 8MDF5V39QO
BANANA BOATTITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLC4f5896a6-0639-5589-e063-6294a90a45a92026-04-13WarningsExact identifier
unii: 15FIX9V2JP
MultitamFOLIC ACIDPureTek Corporationcee15842-4a9e-c6ba-e053-2a95a90aebc52026-04-13Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Nicotine Polacrilex Coated MintNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700002c420ee4-0ed0-4a3f-bc92-202d825d0ca32026-04-13WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine Polacrilex Coated Ice MintNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 70000b075c3cb-d610-4a9c-8cf0-e4b9001bc86a2026-04-13WarningsExact identifier
application number: ANDA204794
application number: ANDA204833
ndc (package): 70000-0344-1
ndc (package): 70000-0348-1
ndc (package): 70000-0348-2
ndc (package): 70000-0344-2
ndc (product): 70000-0348
ndc (product): 70000-0344
ndc11 (package): 70000034801
rxcui: 314119
rxcui: 311975
spl id: 995f5f15-e607-4cca-85e3-ec8942812bce
spl set id: b075c3cb-d610-4a9c-8cf0-e4b9001bc86a
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacy65ceb67b-dc22-4f5f-bfce-d6e957835eb32026-04-13WarningsExact identifier
unii: 6M3C89ZY6R
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Nicotine Polacrilex Coated FruitNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 70000d6c7a2ab-109d-40df-bce0-30c3531eb9822026-04-10WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine Polacrilex OriginalNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700004acbda22-9c87-49f2-ad5f-55b1e54bdf2e2026-04-10WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.4a8be3aa-9bd9-4bb1-af98-a940c13b2bd02026-04-10WarningsExact identifier
unii: 3A3U0GI71G
unii: 45P3261C7T
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyba373c62-65eb-43ad-88e3-bb2c13df588c2026-04-10WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: 3A3U0GI71G
unii: 45P3261C7T
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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