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 5 of 48 · 953 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companybfdf3918-3116-4351-b0a8-4c515e2e1f412026-07-14WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Kirkland Signature Quit 2NICOTINE POLACRILEXCostco Wholesale Company17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c12026-07-14WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companyb9dd4e89-0023-4552-bdd6-1c046ce3bd872026-07-14WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
coated nicotineNICOTINE POLACRILEXPublix Super Markets Inc97b06ada-b8b8-49fc-bc65-c3e835ef149b2026-07-13WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc61c69497-91f9-45bf-ad48-33ac73e63a752026-07-10WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Nicotine Transdermal System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inca9402b4b-f8e6-4e96-ad45-5875dfd0c8892026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEAmneal Pharmaceuticals Private Limitedac91e834-e693-43a2-829b-56793453e8cc2026-07-09Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Habitrol Nicotine Polacrilex Lozenge MintNICOTINE POLACRILEX LOZENGE 2 MGDr. Reddy's Laboratories Inc.836bae74-076b-3c92-dee9-22b8519b529d2026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inc8cb5577b-48c0-47f8-8979-0ab54d7130452026-07-09WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.6b0342dd-120f-a16e-098a-dc45b14d3d3a2026-07-09WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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