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 9 of 48 · 953 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COATED NICOTINENICOTINE POLACRILEXPublix Super Markets Inc8868a487-d77b-4c6f-8ef9-5a6fe22ce0ad2026-06-18WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
care one nicotineNICOTINE POLACRILEXAmerican Sales Companye9558a4e-a0ad-4391-9b9c-85edb61523c12026-06-17WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCcbf094d4-2357-426d-8205-9b59c332854f2026-06-16WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLCc65c1c40-4c8f-40bb-ace4-8bbc9ecf630e2026-06-16WarningsExact identifier
application number: ANDA074507
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC4d669f54-5031-4b89-a546-6cdefc648fc32026-06-16WarningsExact identifier
application number: ANDA074707
rxcui: 311975
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 8MDF5V39QO
NICOTINENICOTINE POLACRILEXPublix Super Markets Inc05f4c92b-1d57-4ef2-a53d-d4069d2730f32026-06-15WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc22026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXSafewayed4fe766-1329-4d57-894d-3b977dd07b5c2026-06-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
CareOne nicotineNICOTINE POLACRILEXAmerican Sales Companyffaa553c-7323-4d9c-87f4-2846bc51fa7c2026-06-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway3591828f-dff0-4cb7-ab0e-d43704243dc22026-06-12WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Bbbc4fd9f-b1f5-4691-b980-3424c91e4c882026-06-12WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
nicotineNICOTINE POLACRILEXH E B8c288d15-d1ea-42b6-8cfb-f056d59fd3e02026-06-12WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf9759891-7d3d-4714-8f8b-92d0a499e52e2026-06-11WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc2c43a498-a4fb-4ed1-b4ae-aecfd334945b2026-06-11WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
blipNICOTINE POLACRILEXBlip Products, Inc.451863c3-4c17-448e-9225-a5492344af152026-06-11WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc8828d4f5-7b3a-4f1c-8f78-fa820ffa84412026-06-11WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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