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 39 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINENICOTINE POLACRILEX MINIAurohealth LLC169c7976-f865-4716-953d-383e435d67c52024-06-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXL. Perrigo Companyee345181-4999-4948-9589-7d70d61885ad2024-06-18WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Insect sting relief pad 01SODIUM BICARBONATECosmuses Cosmetics (Ningbo) Co., Ltd.1b0f0088-6482-6de7-e063-6294a90aeeb72024-06-17WarningsExact identifier
unii: 8MDF5V39QO
foster and thrive STEP 3NICOTINE TRANSDERMAL SYSTEMStrategic Sourcing Services LLCd992645a-f185-48be-887a-e89ab5fcf0392024-06-11WarningsExact identifier
unii: 6M3C89ZY6R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEANI Pharmaceuticals, Inc.63c3bd6c-a586-4ec0-8f45-ed936936dfeb2024-06-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINERugby Laboratories2dd4cbda-5c46-4655-b69d-21b7d2e912cf2024-06-05WarningsExact identifier
unii: 6M3C89ZY6R
good sense nicotineNICOTINE POLACRILEXA-S Medication Solutionsaf4323b6-5240-4697-992a-512c4d0983402024-05-15WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXCVS Pharmacya7348e93-bc5d-48d8-b2a4-daf921343d442024-05-08WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
up and up cherry nicotineNICOTINE POLACRILEXTarget Corporation85d82812-9f90-401f-8a2c-729cbfdf4c782024-03-29WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
up and up mint nicotineNICOTINE POLACRILEXTarget Corporation740833d6-5406-4609-9d14-bd5c9072fe9a2024-03-28WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
up and up mint nicotineNICOTINE POLACRILEXTarget Corporationcf7e3e9d-ec46-49de-b760-63d89c67823a2024-03-28WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLC991704ed-781a-489b-8b56-0b558e8fc3852024-03-21WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
SODIUM BICARBONATESODIUM BICARBONATESun Pharmaceutical Industries Limited5ae65432-04a1-4b6b-8536-2535064fc7822024-03-06Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCfdee1637-8049-4bc5-b196-b6d854c9f9f32024-03-05WarningsExact identifier
rxcui: 359817
rxcui: 359818
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATESteriscience Specialties Private Limitedeb2996b4-c04c-4678-b8a9-5cbbe509bb702024-03-04Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Sodium BicarbonateSODIUM BICARBONATEBryant Ranch Prepack4493d7c5-f2c3-416e-a5c1-35398fc7f61d2024-02-29Boxed warning, WarningsExact identifier
unii: 8MDF5V39QO
SODIUM BICARBONATESODIUM BICARBONATEHF Acquisition Co LLC, DBA HealthFirsta5eedf57-2783-b3d0-e053-2a95a90a9ff52024-02-22Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINE POLACRILEXWalgreens446c857f-2380-4019-9a82-9fb9ee060d082024-02-21WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporation65a612e8-18d3-49fd-844f-4ccd0210acd32024-02-20WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
up and up nicotineNICOTINE POLACRILEXTarget Corporationc0c667b8-7384-4970-8f27-f108192c32562024-02-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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