FDA.reportPublic FDA data

NDC 57237-321-27 - 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
57237-321
Requested NDC
57237-321-27
Package NDCs from labels
57237-321-42, 57237-321-72, 57237-321-27, 57237-321-81
Manufacturer
A-S Medication Solutions
Effective date
2026-10-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Mini - A-S Medication SolutionsA-S Medication Solutions2026-10-13HUMAN OTC DRUG LABEL
Drug FactsRising Pharma Holdings, Inc.2025-12-06HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-321-27NicotineMini27 in 1 BOTTLE, PLASTICLOZENGE273
57237-321-42NicotineMini1 in 1 BOXLOZENGE13
57237-321-42NicotineMini24 in 1 BOTTLE, PLASTICLOZENGE243
57237-321-72NicotineMini3 in 1 BOXLOZENGE33
57237-321-72NicotineMini24 in 1 BOTTLE, PLASTICLOZENGE243
57237-321-81NicotineMini3 in 1 BOXLOZENGE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-321NICOTINE MINI (NICOTINE POLACRILEX) LOZENGE [RISING PHARMA HOLDINGS, INC.]2Current NDC, 6 package rows20241011_05990040-5bd7-4622-8fe3-2d7573904dfa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-321-72EA - Each57237-32193f716b7-07bb-41e5-94c5-b124eb91423612023-09-05
57237-321-81EA - Each57237-3211bacfcaf-3a1b-492e-b2b5-f0d69cc2d7a812026-01-08

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 44 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 700006edf8c50-d3b9-469a-ad57-37c05e0988622022-10-20WarningsExact identifier
application number: ANDA207868
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC810932e0-a982-400a-b43d-b847152f685b2022-06-24WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCdcc0b057-3d5e-4aeb-ac31-478d7a2f47fa2022-06-24WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: Z0H242BBR1
NICOTINENICOTINE POLACRILEXAurohealth LLC1909cf25-bce8-4880-abc6-548d28a7285d2022-03-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCfa730ae3-c2b3-4ea4-8e50-f819b205d1682022-03-07WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCafc71ce1-ded2-4259-a9e1-faca692b90a12022-01-11WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEInternational Medication Systems, Limited77698221-a01d-4568-a7bc-d3d4e982875d2021-12-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Rexall NicotineNICOTINE POLACRILEXDolgencorp, LLC83b053f6-304b-4f9c-8a6d-6649998708b22021-12-15WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC6f73126a-32e5-48b9-8013-6afb0ebe8fd82021-09-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLC8cc8de15-5906-4749-99f2-2884c6a1842a2021-09-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Service0294974c-8d07-4a2e-b929-648c712b6ebe2021-06-01WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Servicec1f1048b-e581-45bf-b344-8e2b0b7488bb2021-05-27WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
8.4% SODIUM BICARBONATE8.4% SODIUM BICARBONATEHF Acquisition Co. LLC, DBA HealthFirst74d8bb7a-9e7a-105f-e053-2a91aa0aec922021-05-03Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEMedical Purchasing Solutions, LLCbfc9c321-665c-ca97-e053-2995a90a79542021-04-12Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyfac52e0d-7a02-451e-a36b-30d49e929d3e2021-03-31WarningsExact identifier
unii: 6M3C89ZY6R
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.99eda7db-ce40-446f-e053-2995a90a95aa2020-12-07WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense Omeprazole and Sodium BicarbonateOMEPRAZOLE, SODIUM BICARBONATEL. Perrigo Companybcf32242-de17-4da1-b707-4ce26262eb782020-11-16WarningsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINE POLACRILEXMeijer Distribution Incdc70703e-2c55-4178-a5d5-50f762ab64922019-04-24WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXMeijer Distribution Inc1d2cfb36-2d94-468c-8da1-6b6999b07d7b2019-04-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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