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 45 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nicotineNICOTINEH E B98633912-74d8-49db-a03e-4a3f882297ac2019-04-17WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINEH E B691f3f8d-7242-4855-b80b-4d5af0490b372019-04-16WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway22010ed8-7fa6-402a-a314-523538183a552018-11-01WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway664c3faf-7cab-4bda-8987-07acb8e1142b2018-10-31WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
exchange select nicotineNICOTINE POLACRILEXArmy & Air Force Exchange Servicee926cf6f-305a-4912-be07-a45bb79058222018-09-21WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: Z0H242BBR1
SODIUM BICARBONATESODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLC15605a6d-6c90-47d5-9d1f-f66a3f27d5fc2017-12-13WarningsExact identifier
unii: 8MDF5V39QO
berkley and jensen nicotineNICOTINE POLACRILEXBJWC357123fc-0972-4683-ab52-f95d46c1b6c92017-11-09WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Sodium Bicarbonate AntacidSODIUM BICARBONATERichmond Pharmaceuticals, Inc.e0b2f0d3-3849-4bdf-b3d4-e14e520e36ce2017-11-01WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATERichmond Pharmaceuticals, Inc.fa10d93d-b3ed-4675-a117-f573d9e72bca2017-10-30WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEExela Pharma Sciences, LLCe9698a4f-1a95-4f28-a945-e8009d1d6dd42017-09-27Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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