FDA.reportPublic FDA data

NDC 63548-0262-01 - Nicotine Mini

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
63548-0262
Requested NDC
63548-0262-01
Package NDCs from labels
63548-0262-7, 63548-0262-1, 63548-0262-0, 63548-0262-01
Manufacturer
PLD Acquisitions LLC DBA Avéma Pharma Solutions
Effective date
2025-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Mini - PLD Acquisitions LLC DBA Avéma Pharma SolutionsPLD Acquisitions LLC DBA Avéma Pharma Solutions2025-03-27HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63548-0262-02023-02-09Drug Facts
63548-0262-12023-02-09Drug Facts
63548-0262-72023-02-09Drug Facts
63548-0262-02023-01-30Drug Facts
63548-0262-12023-01-30Drug Facts
63548-0262-72023-01-30Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63548-0262-0NicotineMini4 in 1 BOXLOZENGE47
63548-0262-0NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE277
63548-0262-1NicotineMini3 in 1 BOXLOZENGE37
63548-0262-1NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE277
63548-0262-7NicotineMini1 in 1 BOXLOZENGE17
63548-0262-7NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE277

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63548-0262NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [PLD ACQUISITIONS LLC DBA AVÉMA PHARMA SOLUTIONS]7Current NDC, Legacy NDC, 6 package rows20250330_71db232e-b169-47d0-b269-5e14fa75f3a2.zip

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 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companyccee1b99-e58b-4377-9ae8-9f215e2c975d2026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratoriesd67149d5-4766-4b84-8205-f1a6b692f4c92026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companybfdf3918-3116-4351-b0a8-4c515e2e1f412026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
Kirkland Signature Quit 2NICOTINE POLACRILEXCostco Wholesale Company17f17eb6-ebc3-4a71-9f1b-41e2b5dcf6c12026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companyb9dd4e89-0023-4552-bdd6-1c046ce3bd872026-07-14WarningsExact identifier
unii: 6M3C89ZY6R
coated nicotineNICOTINE POLACRILEXPublix Super Markets Inc97b06ada-b8b8-49fc-bc65-c3e835ef149b2026-07-13WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Company5c89061b-1452-4962-9f25-212f2ae8e41e2026-07-13WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc61c69497-91f9-45bf-ad48-33ac73e63a752026-07-10WarningsExact identifier
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
rxcui: 359818
unii: 6M3C89ZY6R
nicotine coatedNICOTINE POLACRILEXPublix Super Markets Inca0113a1d-3691-4f18-9950-ae6d8d7d19ea2026-07-10WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories0f5af06c-ab1c-48d0-a39f-4d1d7e78ff252026-07-10WarningsExact identifier
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
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.003b863c-06b0-715d-ccc2-b7da4deac6212026-07-09WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPublix Super Markets Inc8c296647-00a1-43d0-acd1-7c1e92f368832026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED0ef9e55d-83e0-4ba5-a905-8cddb0db00192026-07-09WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.b0fdb36d-4cf5-8a91-3da1-90e3587450f92026-07-09WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
Habitrol Lozenge Original FlavorNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.87714b79-05b3-f3c2-6505-5923e4f488712026-07-09WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
Habitrol Lozenge CherryNICOTINE POLACRILEXDr. Reddy's Laboratories Inc.5a464242-7d63-141e-808e-c41676cf4b782026-07-09WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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