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 32 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company788214db-3f78-4209-b3b6-d59cc9be34212026-02-18WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXA-S Medication Solutions83b3b56e-0081-41df-818c-bccc4a996b7f2026-02-18WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXKroger Company965be729-d417-4ae6-a2a9-ed06c2287d422026-02-17WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC9f2f06c3-4d9b-4c1a-85e3-26f021be5d7c2026-02-16WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.f801e8b2-b789-41f4-b35e-ea3a82d2bb9c2026-02-13WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC17cf8f3d-6491-4cd8-a447-3c7533f76daf2026-02-13WarningsExact identifier
unii: 6M3C89ZY6R
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC1a916693-6092-4875-872a-7438816c0ddf2026-02-12WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCcb306cdf-bab5-4b13-986b-21ade4764f002026-02-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC440178c0-e9e4-4729-bcd9-f640742c40802026-02-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXKroger Company756c6b45-704e-4684-96ba-4df3ef27552c2026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC99da90fa-00ff-4c62-91a2-1e434dadaf412026-02-12WarningsExact identifier
unii: 6M3C89ZY6R
topcare nicotine polacrilexNICOTINE POLACRILEXTopco Associates LLCd0403746-f866-42da-ad66-2a686c8bce012026-02-11WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ee883114-35ac-4b81-b8f1-4903d646dd842026-02-11WarningsExact identifier
application number: ANDA204833
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensb1174e20-e1ad-4c58-8b32-683b7e98fca92026-02-10WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXMeijer Distribution Inc7be33f47-03de-458d-81b9-5a8d940520752026-02-10WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreensb3e33137-bf40-4801-b01f-27a0d41edba42026-02-10WarningsExact identifier
application number: ANDA204794
rxcui: 314119
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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