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 29 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461227b789f4c-7786-4b32-9460-69de57e0a3aa2026-03-17WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461226432c7fc-02d3-42a4-bd46-d48250a1d4d22026-03-16WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
equate omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEWALMART INC.c24c3326-99da-4c7d-aecc-7b4a8ac3f04e2026-03-15WarningsExact identifier
unii: 8MDF5V39QO
HYDRATING TINTED MOISTURIZER SPF50HYDRATING TINTED MOISTURIZER SPF50NING PTE. LTD.4cf8d3d3-eebf-2da0-e063-6294a90a70652026-03-14WarningsExact identifier
unii: 15FIX9V2JP
TINTED WATERY SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEKSISTERS PTE. LTD.4ced53d0-8bfc-ff8e-e063-6294a90a9dbd2026-03-13WarningsExact identifier
unii: 15FIX9V2JP
Daily Moisturizing Mineral SunscreenBROAD SPECTRUM SPF30EDINA PLASTIC SURGERY,LTD.4d056e2b-5813-da42-e063-6294a90ac5192026-03-13WarningsExact identifier
unii: 15FIX9V2JP
NICOTINE TRANSDERMAL SYSTEMNICOTINEA-S Medication Solutionscfb56e3e-ac5d-4086-a5d3-23080844b3e12026-03-13WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensfe5c4bfd-a792-4923-b2db-16be44d599ea2026-03-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612239640129-2d7a-4ec5-81a1-e14b11d3d3ee2026-03-12WarningsExact identifier
unii: 6M3C89ZY6R
Neutrogena Healthy Skin Liquid Makeup Broad Spectrum SPF 20 - Cool Bronze 440CTITANIUM DIOXIDEKenvue Brands LLC4c335d9c-40ca-c0ce-e063-6394a90ac20a2026-03-11WarningsExact identifier
unii: 15FIX9V2JP
nicotineNICOTINE POLACRILEXH E Bb1a13942-1fad-40da-8664-f70574b950d72026-03-11WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXHyVee Incb9257174-fbd4-453d-aa23-77d5a8f91b892026-03-11WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Lower GI and Probiotic RestorationAETHUSA CYNAPIUM, ALLIUM SATIVUM, BAPTISIA TINCTORIA, CAPSICUM ANNUUM, CARBO VEGETABILIS, CHAMOMILLA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, COLOCYNTHIS, CONDURANGO, GAMBOGIA, GRATIOLA OFFICINALIS, LAC VACCINUM, LACTICUM ACIDUM, NATRUM CARBONICUM, NUX VOMICA, PODOPHYLLUM PELTATUM, SEPIA AND SILICEA.King Bio Inc.2e1f3ca1-9036-4f14-bd3c-d0eed9a9ff932026-03-10WarningsExact identifier
unii: 45P3261C7T
SODIUM BICARBONATESODIUM BICARBONATEHospira, Inc.084f5572-8c1f-4802-b179-ca0cc838fc682026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEHospira, Inc.0c24b592-4bc8-456f-acac-9c9525844a062026-03-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Gout Symptom ReliefAMMON PHOS, BELLADONNA, COLCHICUM AUTUMNALE, FORMICUM ACIDUM, FRAXINUS EXCELSIOR, LEDUM PALUSTRE, NATRUM CARBONICUM, NUX VOMICA AND URTICA URENS.King Bio Inc.41dc03fc-169b-4691-bd62-9a41d7a6d2f72026-03-06WarningsExact identifier
unii: 45P3261C7T
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMH-E-Bda35e19d-b0aa-8a5f-140e-7601bd2027fe2026-03-06WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMTopco Associates LLCa631d31d-38e6-1772-8b6d-57672b785d982026-03-06WarningsExact identifier
unii: 6M3C89ZY6R
BEST SMELLING SALTSAMMONIUM CHLORIDE, SODIUM CARBONATE INHALANTHyvia Health LLC4c5cde0c-1de7-ce67-e063-6394a90a95792026-03-06WarningsExact identifier
unii: 45P3261C7T
Good Mood EnhancerAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, IGNATIA AMARA, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SEPIA, SINAPIS ARVENSIS, FLOS AND TABACUM.King Bio Inc.26150aa1-7729-4f64-a761-eab251f046e52026-03-06WarningsExact identifier
unii: 45P3261C7T

Reported adverse events (FAERS/openFDA)#

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