FDA.reportPublic FDA data

NDC 0536-1362-25 - Nicotine

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
0536-1362
Requested NDC
0536-1362-25
Package NDCs from labels
0536-1362-25, 0536-1362-34, 0536-1362-06, 0536-1362-23
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-08-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine - Cardinal Health 107, LLCCardinal Health 107, LLC2026-08-24HUMAN OTC DRUG LABEL
Nicotine - Rugby LaboratoriesRugby Laboratories2026-07-10HUMAN OTC DRUG LABEL
Rugby Nicotine Polacrilex Gum, Mint Flavor - A-S Medication SolutionsA-S Medication Solutions2025-09-23HUMAN OTC DRUG LABEL
Nicotine Polacrilex Gum 2 mg and 4 mg MINT - RugbyATLANTIC BIOLOGICALS CORP.2025-06-27HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1362-06Rugby Nicotine Polacrilex Gum, Mint Flavor5 in 1 CARTONGUM, CHEWING518
0536-1362-06Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-1362-23Rugby Nicotine Polacrilex Gum, Mint Flavor11 in 1 CARTONGUM, CHEWING1118
0536-1362-23Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018
0536-1362-34Rugby Nicotine Polacrilex Gum, Mint Flavor2 in 1 CARTONGUM, CHEWING218
0536-1362-34Rugby Nicotine Polacrilex Gum, Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1362RUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]16Current NDC, Legacy NDC, 6 package rows20241219_0f5af06c-ab1c-48d0-a39f-4d1d7e78ff25.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1362-06EA - Each0536-1362f6aa756d-b9bf-4a97-9457-55210ab98cf212013-02-13
0536-1362-23EA - Each0536-1362b9e570a5-cd24-4c9b-bf29-fd400f0f6ba412013-02-13
0536-1362-34EA - Each0536-1362eebac00b-7910-4f44-9425-2020c54654e712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ERUGBY NICOTINE POLACRILEX GUM, MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2

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 1 of 51 · 1,013 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-09-09WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation09bc9f57-fed2-42d9-b4f2-2b71b8baa0a92026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXRite Aid Corporationc94d46b1-f526-4af0-8f7c-8261b9ed68412026-09-09WarningsExact identifier
unii: 6M3C89ZY6R
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyae802de5-8e1b-439f-ab81-db4bd7241c912026-09-09WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.d0d1a5ef-fd4c-4854-9453-68808cc0fab02026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXHC Jones, Inc.e07226e8-3be4-46e4-aa4f-c5d88db1ccfa2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXSixarp, LLC5a94092b-f80e-c656-e063-6294a90ab15a2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.80e9ee49-2b38-4b59-80a7-524021bf2b212026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXHC Jones, Inc.ff9e34ff-5086-4e1b-9220-27ac2ac1069c2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Polacrilex Original FlavorNICOTINE POLACRILEXPublix Supermarkets, Inc.540c88bd-70dc-416a-8d8e-0a33b2b295632026-09-02WarningsExact identifier
rxcui: 314119
rxcui: 311975
unii: 6M3C89ZY6R
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
up and up citrus mini nicotineNICOTINE POLACRILEXTarget Corporation7457f30e-0281-49db-91e0-ddaedaa6b2572026-09-01WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCd6f7dea2-6375-4057-8947-314a429fa4922026-09-01WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC2e24f6d7-957e-4c7c-a486-8a1c1b47d53f2026-08-31WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmazon.com Services LLC8430a12b-4a7b-48a1-aa8f-7e55c5fde3c02026-08-28WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inca1c85adc-8b42-40ad-91b4-0bf92a6341a52026-08-27WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepackb2f4506b-b575-4ed8-b10b-935451ea34512026-08-27WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXBryant Ranch Prepacka3ca2479-9703-41de-918a-881da16e5c982026-08-27WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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