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 30 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicorette PeppermintNICOTINE POLACRILEXHaleon US Holdings LLC990a4a65-d573-46a9-889d-60afb00189442025-07-31WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAveva Drug Delivery Systems Inc.7cdad3b0-82d5-400f-a7f5-ac2e9d4478fe2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINEStrategic Sourcing Services LLCa08022ff-e412-47f9-8132-318f55528c5c2025-07-30WarningsExact identifier
unii: 6M3C89ZY6R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2bf501-fd81-6ffa-e063-6394a90afe422025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEPHOENIX RX LLC3b2cf6fd-72cb-fa53-e063-6394a90a674a2025-07-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackc2627853-945b-42d8-8351-39028e513d772025-07-29WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepack16ece78d-c66e-43c1-953a-f774797ae0972025-07-29WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.a18dde9f-700f-4572-a6aa-577dbacdf3142025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXLucy Goods, Inc.20aa42c6-14e3-46c5-ba0f-fef217e0b1c22025-07-29WarningsExact identifier
unii: 6M3C89ZY6R
Anti-EmpachoSODIUM BICARBONATEMenper Distributors, Inc.43807221-58f0-434d-be2d-fa0f54b95db82025-07-22WarningsExact identifier
unii: 8MDF5V39QO
Sodium Bicarbonate AntacidSODIUM BICARBONATEMenper Distributors Inc.6efb4da0-03ae-4df6-acd7-e8023d20d4b32025-07-22WarningsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINE POLACRILEXLucy Goods, Inc.bca1c2ab-2263-429d-9f09-f848dd3d826e2025-07-21WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.150faf42-491f-403b-869b-48edd431d1cc2025-07-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Maxi NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.7c2e0872-75f6-4c4f-afff-3579375708de2025-07-18WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXRugby Laboratories, Inc.be17cbe9-43bb-424e-9d91-fba4f02691bb2025-07-18WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXLucy Goods, Inc.76034dd1-361c-442c-92aa-8fa7cf47a5072025-07-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESShenzhen TeLaFaErJiaLuo Technology Co., Ltd.3a1abd26-c0aa-8a65-e063-6294a90ab66e2025-07-17WarningsExact identifier
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutions3e9a5f94-9db2-4cac-8ab9-50fcedfe0e052025-07-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: 8MDF5V39QO
Zegerid OTCOMEPRAOLE, SODIUM BICARBONATERiley Consumer Care LLC8d00c19a-d86b-4a2f-8791-b320ad3ca7812025-07-15WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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