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 2 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepacka3ca2479-9703-41de-918a-881da16e5c982026-08-27WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf6cc8d50-2d8d-4ed4-930a-a2479b1ebffe2026-08-27WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreensd933d32c-cb4a-41b2-9563-da74cf2d77e42026-08-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreens97ce52b1-d98e-4216-99c2-7e341c8fec432026-08-25WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCf8806ec3-a1c0-47a9-9660-2628dca4623e2026-08-25Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINE POLACRILEXAmazon.com Services LLC4ab742f2-2599-4d9f-83c5-9338d66ad6cf2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCardinal Health 107, LLCebab2c3a-4fda-40d6-8f54-972e1c6ee69a2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
Quit smoking patchesQUIT SMOKING PATCHESShenzhen yuehaotong Technology Co., Ltd59b0c0e9-dc03-ec1e-e063-6394a90a8a872026-08-23WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCb957f757-2b34-49b2-a68b-a7bc9e8dd8b22026-08-21WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXWalgreen Company5dd116ea-d031-439c-b06c-2f77230bc4462026-08-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCe40a534e-8083-454d-9667-826bfbac397c2026-08-19WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEAmazon.com Services LLCbb453f26-c7df-4cce-8793-337cb5d5f9a92026-08-19WarningsExact identifier
unii: 8MDF5V39QO
nicotineNICOTINE POLACRILEXAmazon.com Services LLCbc1b6b41-d069-470e-90ca-a441ab97f96a2026-08-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
FiberconCALCIUM POLYCARBOPHILMedtech Products Inc.59534afd-fe38-818a-e063-6394a90a21ea2026-08-18WarningsExact identifier
unii: 8F049NKY49
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsExact identifier
application number: ANDA207868
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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