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 16 of 45 · 891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole/BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEProficient Rx LP4d642036-7175-4f29-9f07-dbd282231d4a2026-04-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMAmerisourceBergen Drug Corporation8a5c7835-3ab1-b3f8-e9db-e5d0cb42b59e2026-03-31WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal SystemNICOTINE TRANSDERMAL SYSTEMQuitine LLCe4761ed6-509b-4e43-88e0-b0229d24859a2026-03-30WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXHyVee Inc9087e72a-6061-4b11-b41d-c9bfd2c20ec32026-03-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex Coated MintNICOTINE POLACRILEXChain Drug Consortium, LLCb4ac0a22-3556-4591-aa7b-e09c6010adc82026-03-26WarningsExact identifier
unii: 6M3C89ZY6R
Rapidol Sodium BicarbonateSODIUM BICARBONATEPharmadel LLCb4c9a653-6f51-7c98-e053-2995a90ada372026-03-26WarningsExact identifier
unii: 8MDF5V39QO
Nicotine PolacrilexNICOTINE POLACRILEXChain Drug Consortium, LLC9c115cd5-1952-4f1e-8e88-27f2c528e91f2026-03-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreensdda17eef-cd75-4c82-b468-09111298282d2026-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXWalgreens826f63b2-fd18-4213-be38-a430d78897cb2026-03-25WarningsExact identifier
unii: 6M3C89ZY6R
Sodium Bicarbonate AntacidSODIUM BICARBONATEAphena Pharma Solutions - Tennessee, LLCbba7d5bf-c94b-4ee4-a399-9a2818d84c782026-03-23WarningsExact identifier
unii: 8MDF5V39QO
NicotineNICOTINE POLACRILEXWalgreensd6c6c753-f604-473c-88b4-b5f83f1dd2932026-03-23WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreens69ffbb37-e26c-4214-8d09-0bbabed253102026-03-20WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXDolgencorp, Inc. (DOLLAR GENERAL & REXALL)11e537db-7dc7-4b28-97eb-da70c80d8fe32026-03-19WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXHyVee Inc6415ebf4-5b6f-4811-997d-27c76893bc042026-03-19WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612253c82cf8-d97b-4a5a-a357-fb74a74d1ef32026-03-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Transdermal System step 3NICOTINECARDINAL HEALTH 110, LLC. DBA LEADERdbbed17b-8ad3-05fb-fb63-03fbb75eae052026-03-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4d46110b-5aa7-5261-e063-6394a90a423a2026-03-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612251cf7563-889d-4726-8f4c-e8efe02904322026-03-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 4612203d0bfa1-cb23-408a-8d8e-24aa0e05bf4f2026-03-18WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXFamily Dollar (FAMILY WELLNESS)d353b75f-3fc3-4958-92c6-08df6bdf283c2026-03-18WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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