FDA.reportPublic FDA data

NDC 70000-0341-01 - Nicotine Polacrilex Original

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
70000-0341
Requested NDC
70000-0341-01
Package NDCs from labels
70000-0341-1, 70000-0341-01
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Original - CARDINAL HEALTH 110, LLC. DBA LEADER 70000CARDINAL HEALTH 110, LLC. DBA LEADER 700002026-04-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0341-1Nicotine PolacrilexOriginal50 in 1 CARTONGUM, CHEWING5012
70000-0341-1Nicotine PolacrilexOriginal1 in 1 BLISTER PACKGUM, CHEWING112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0341NICOTINE POLACRILEX ORIGINAL (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]10Current NDC, Legacy NDC, 2 package rows20241121_4acbda22-9c87-49f2-ad5f-55b1e54bdf2e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0341-1EA - Each70000-03411068710c-a1be-4615-9091-45260eac287712018-11-06

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 4 of 48 · 953 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINE POLACRILEXRite Aid Corporationcd17f3b4-dddd-4387-9fb1-1efa32ba1d2b2026-07-24WarningsExact identifier
unii: 6M3C89ZY6R
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
nicotineNICOTINE POLACRILEXPublix Super Markets Inc4ddba70a-3f45-4c76-a12a-6da256e9afc52026-07-23WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLCc6c9582c-004d-4925-b147-add5f28f38562026-07-23WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacyab1407e3-9092-438c-b684-8194e4ee71af2026-07-23WarningsExact identifier
unii: 6M3C89ZY6R
Up and Up NicotineNICOTINE POLACRILEXTarget Corporationa4bf013b-286b-486c-bb8f-2defb3881d4c2026-07-23WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Incecdfe02c-813b-4c1e-9e02-d7c544a896442026-07-23WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Incfd93fdf4-fa48-4373-aac7-894866a0b18d2026-07-22WarningsExact identifier
unii: 6M3C89ZY6R
Rstrvbr QUIT SMOKINGNICOTINE21MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5e9691-727f-6bcd-e063-6294a90aadfc2026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
Rstrvbr QUIT SMOKINGNICOTINE14MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5eec19-7f9a-d277-e063-6294a90ace952026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
Rstrvbr QUIT SMOKINGNICOTINE7MG QUIT SMOKINGJiangxi Yudexi Pharmaceutical Co., LTD4a5f124e-2dd7-16b8-e063-6294a90a5cdb2026-07-21WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc00b40bb3-3785-4a53-804e-633795e87f712026-07-20WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc31b1a48e-8651-41d7-b693-6509a344906a2026-07-20WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories621eb214-0716-4306-829f-6185a77f24d52026-07-16WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
nicotine miniNICOTINE POLACRILEXAmazon.com Services LLCcc6fd7f3-8ba2-4d60-bafa-a6716f65545e2026-07-16WarningsExact identifier
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc2eca67db-1b7c-43dd-91af-4060e9b8e9d32026-07-15WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories1fc88637-4329-486e-82ab-19eeb06080a62026-07-15WarningsExact identifier
application number: ANDA074707
application number: ANDA074507
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
EQUATE NICOTINENICOTINE POLACRILEXWALMART INC.b6379f86-1528-465d-9527-bd2fead0068f2026-07-15WarningsExact identifier
unii: 6M3C89ZY6R
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companyccee1b99-e58b-4377-9ae8-9f215e2c975d2026-07-14WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratoriesd67149d5-4766-4b84-8205-f1a6b692f4c92026-07-14WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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