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 28 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.cb657607-b038-47ee-b4e7-a5f419a14c332025-10-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Topcare NicotineNICOTINE POLACRILEXTopco Associates LLC69159b7c-206e-457d-88e2-f7ff0a12a7932025-10-03WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotine miniNICOTINE POLACRILEXWalgreen Company33e456bb-1d5d-4b06-8f06-8bb4eab5b1fd2025-10-02WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Rugby Nicotine Polacrilex Gum, Mint FlavorNICOTINE POLACRILEXA-S Medication Solutions7b70162e-0087-466f-9b8b-8289b6e90e392025-09-23WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEFresenius Kabi USA, LLC0ab55004-bb63-436d-ad77-cd37969053702025-09-23Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
berkley and jensen nicotine polacrilexNICOTINE POLACRILEXBJWCb586ce1c-77cd-497c-b22c-8c97f54583ba2025-09-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Stomachin AntacidMAGNESIUM CARBONATE AND SODIUM BICARBONATEChang Kuo Chou Pharmaceutical Co., Ltd.60fa0650-8785-4cb3-8f88-1a437296252f2025-09-19WarningsExact identifier
unii: 8MDF5V39QO
members mark nicotineNICOTINE POLACRILEXSam's West Incd185b5e7-9bb1-4d16-b146-1fbfba8740532025-09-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
foster and thrive nicotineNICOTINE POLACRILEXStrategic Sourcing Services LLC7b1b5f6e-c5ee-48fc-85ee-2e11c30213e42025-09-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXKroger Company0b1874bd-f908-485a-b045-7d0050be7bb22025-09-13WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC03b27d95-f2cb-43d4-9bc3-55ea66fadb0d2025-09-13WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
mini nicotineNICOTINE POLACRILEXMeijer Distribution Inc426b2f92-561d-476b-959c-cdd0fa37be562025-09-12WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc04f2b325-2243-4c6f-880c-45f2543091da2025-09-12WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsExact identifier
unii: 8MDF5V39QO
stop smoking aidNICOTINE POLACRILEXPublix Super Markets Inc63d4ceab-2474-49cd-bb4f-63728eee6ac52025-09-05WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Mini NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.237471f8-ce0f-423b-993f-b4380fd890ff2025-09-02WarningsExact identifier
application number: ANDA207868
rxcui: 359818
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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