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
Rising Pharma Holdings, Inc.
Effective date
2025-12-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
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 9 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXH E Bc690001d-12c4-4a0f-b9b0-2d2b73dcd93a2026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
COATED NICOTINENICOTINE POLACRILEXPublix Super Markets Inc8868a487-d77b-4c6f-8ef9-5a6fe22ce0ad2026-06-18WarningsExact identifier
unii: 6M3C89ZY6R
care one nicotineNICOTINE POLACRILEXAmerican Sales Companye9558a4e-a0ad-4391-9b9c-85edb61523c12026-06-17WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLCcbf094d4-2357-426d-8205-9b59c332854f2026-06-16WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLCc65c1c40-4c8f-40bb-ace4-8bbc9ecf630e2026-06-16WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC4d669f54-5031-4b89-a546-6cdefc648fc32026-06-16WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATE, INJECTIONCivica, Inc.3737e5e5-2296-4a3d-b8f1-dfea1eff19272026-06-15Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: 8MDF5V39QO
NICOTINENICOTINE POLACRILEXPublix Super Markets Inc05f4c92b-1d57-4ef2-a53d-d4069d2730f32026-06-15WarningsExact identifier
unii: 6M3C89ZY6R
BOTASUN QUIT SMOKING NicotineNICOTINE18% MENTHOL 0.3% QUIT SMOKING NICOTINEJiangxi Yudexi Pharmaceutical Co., LTD4fa00db9-def5-dcfa-e063-6394a90ac8c22026-06-14WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAurohealth LLC56a1c778-fc3b-4848-a7e0-b1e4f0a8fbc22026-06-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXSafewayed4fe766-1329-4d57-894d-3b977dd07b5c2026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
CareOne nicotineNICOTINE POLACRILEXAmerican Sales Companyffaa553c-7323-4d9c-87f4-2846bc51fa7c2026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
signature care nicotineNICOTINE POLACRILEXSafeway3591828f-dff0-4cb7-ab0e-d43704243dc22026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXH E Bbbc4fd9f-b1f5-4691-b980-3424c91e4c882026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATECardinal Health 107, LLC60c2a176-8854-4479-b853-d07fe9a1830c2026-06-12WarningsExact identifier
unii: 8MDF5V39QO
nicotineNICOTINE POLACRILEXH E B8c288d15-d1ea-42b6-8cfb-f056d59fd3e02026-06-12WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXPadagis Israel Pharmaceuticals Ltdf9759891-7d3d-4714-8f8b-92d0a499e52e2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
members mark nicotineNICOTINE POLACRILEXSam's West Inc2c43a498-a4fb-4ed1-b4ae-aecfd334945b2026-06-11WarningsExact identifier
unii: 6M3C89ZY6R
blipNICOTINE POLACRILEXBlip Products, Inc.451863c3-4c17-448e-9225-a5492344af152026-06-11WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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