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 32 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCf350e050-2173-43e0-8738-848382ce07002025-06-04WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc78126814-286e-485f-a4ce-77587f3d77e32025-06-04WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Elsophie Nicotine Patches QuitNICOTINE PATCHES QUIT SMOKINGShenzhen Xinxin Yunhai Technology Co., Ltd.36b63da9-94cc-b52a-e063-6394a90a50292025-06-03WarningsExact identifier
unii: 6M3C89ZY6R
Members Mark NicotineNICOTINE POLACRILEXSam's West Inc36c15917-eceb-4f5a-9021-711956e7b51b2025-06-03WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
unii: 6M3C89ZY6R
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINEA-S Medication Solutions13aa171e-7425-47fc-b618-7759840f06182025-05-30WarningsExact identifier
unii: 6M3C89ZY6R
NicotrolNICOTINEPharmacia & Upjohn Company LLCacb7d02d-249b-4645-ac1b-8ff9a56dd2442025-05-29Warnings, Adverse reactionsExact identifier
unii: 6M3C89ZY6R
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
unii: 8MDF5V39QO
Bestmade Natural Products Sodium Bicarbonate (Nat Bicarb)SODIUM BICARBONATEBestmade Natural Products2fad1d83-3c64-f1b3-e063-6294a90aa3e52025-05-26WarningsExact identifier
unii: 8MDF5V39QO
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: Z0H242BBR1
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC5102e242-4d27-4b1f-8a65-2b52ba3f22762025-05-14WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXAAFES/Your Military Exchanges27308f6b-43b9-4b1d-af6b-7a39b79def032025-05-08WarningsExact identifier
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEX MINIAmazon.com Services LLC113e54e3-e9c3-4949-e063-6394a90a6fdf2025-05-02WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEXAmazon.com Services LLC113e0be9-7edc-4766-e063-6294a90af7522025-05-02WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEXAmazon.com Services LLC10ece1fa-f4c2-42ad-e063-6394a90a3a7d2025-05-02WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
AMAZON BASIC CARE NICOTINE POLACRILEXNICOTINE POLACRILEX MINIAmazon.com Services LLC10ee6816-8155-d590-e063-6394a90a9dea2025-05-02WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Sinus Wash PacketSODIUM BICARBONATE, SODIUM CHLORIDEBETTER LIVING BRANDS LLC33ee7b77-0871-4df8-e063-6394a90ac4792025-04-29WarningsExact identifier
unii: 8MDF5V39QO

Reported adverse events (FAERS/openFDA)#

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