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 42 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXCVS Pharmacye23ad78b-f151-44bb-8dfd-7e933c0d11522023-08-30WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLCa0ceda92-78e7-417f-adfc-a085f9b185842023-08-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
NICOTINENICOTINE POLACRILEX MINIBLIP PRODUCTS, INC.e88c8815-4d38-3a59-e053-2995a90afc822023-08-11WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIBLIP PRODUCTS, INC.eb714022-332d-5c6f-e053-2a95a90a75c92023-08-11WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEOMNIVIUM PHARMACEUTICALS LLC.aea54f8d-1cdd-4a5c-a2f7-7317ae4c8fbc2023-08-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc0100787d-59f0-4f7f-ac13-92d1162cdc1b2023-08-04WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Incd0e94dfb-017a-4faf-8423-3417d517f39c2023-08-03WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
basic care nicotineNICOTINE POLACRILEXAmazon.com Services LLCd6566f92-cf41-4032-a66b-3d1cdf661f332023-08-01WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc265e7411-45cd-4bd2-98fc-0401dfa524342023-07-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Equate NicotineNICOTINE POLACRILEXWal-Mart Stores Inc43a24aa7-ba1c-4c5d-9ec8-ed496e299e002023-07-28WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEDr. Reddy's Laboratories Inc.,c6b5f808-4a49-1303-9711-badb022ecd702023-07-19WarningsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEA-S Medication Solutions619cb558-84e5-43ea-91e9-28c764f9f9c02023-06-21Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PEG-3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions7a2d8dab-750f-43c1-933c-4169a840c60c2023-06-20Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
equate nicotineNICOTINE POLACRILEXWALMART INC.0f625e1a-be08-4460-a588-8b42282ac1212023-06-15WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
topcare nicotineNICOTINE POLACRILEXTopco Associates LLC872d8ba6-881c-49f2-9848-1ed3eed768602023-06-15WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreen Companyd2572335-9c54-4745-9a11-eb9b8d34d0cd2023-06-14WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Kirkland Signature NicotineNICOTINECostco Wholesale Company0888a974-a8ba-4cb3-996f-c8abfcb90a6f2023-06-01WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXWalgreen Company8af06c23-80b7-4559-b594-a3a02297306d2023-05-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Kirkland Signature NicotineNICOTINECostco Wholesale Company33098a72-9146-4547-9d0b-ff28c8c800302023-05-26WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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