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 43 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCb620938d-ab2d-0934-e053-2a95a90a84832023-05-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
kirkland signature quit 2NICOTINE POLACRILEXCostco Wholesale Companycb462e10-124e-4ea3-9261-8c1fc7a9e1a62023-05-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
kirkland signature quit 4NICOTINE POLACRILEXCostco Wholesale Companycd1c3493-242c-4981-8561-ebbea938628f2023-05-12WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEMedical Purchasing Solutions, LLCd1636b56-ad83-4439-e053-2a95a90a135e2023-05-02Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: C269C4G2ZQ
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab184645-6fff-40cf-9859-4b8dec9098b22023-03-20WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122ab1df1b4-a831-4de2-be87-38b9cd589db92023-03-20WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Nicotine transdermal system step 3NICOTINEA-S Medication Solutions798a66fa-25d8-4713-b25f-56875431e37d2023-03-02WarningsExact identifier
unii: 6M3C89ZY6R
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Nicotine MiniNICOTINE POLACRILEXEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)4eeaf22c-a839-49c5-b099-77321d590d062022-12-06WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc8c66eb21-dd95-4dcb-8488-e1e768dd8cd62022-12-06WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy4853ee32-521f-4359-8084-438893be43bc2022-11-22WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCVS Pharmacy7fa848c6-3a4a-41f3-b927-1b26b6232e3a2022-11-22WarningsExact identifier
application number: ANDA207868
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCVS Pharmacy8332bb07-72a7-491e-a19b-baff84acefdb2022-11-22WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafewaycb2624de-3908-4091-aea1-f0dc76abd6332022-11-15WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Omeprazole, Sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEGuardian Drug Companye5c6c2cf-fb3b-456a-a0a0-be396d6f83192022-11-08Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC85f05cc6-ae2e-4338-8c1e-c681c2f908582022-11-03WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLCcfe6fb63-2897-4e76-8288-1389f363b3c42022-11-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXCardinal Health (Leader) 7000071ee5a44-b451-4ecd-9fe7-8124b4dae1c52022-10-20WarningsExact identifier
application number: ANDA207868
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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