FDA.reportPublic FDA data

NDC 0536-3112-25 - 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
0536-3112
Requested NDC
0536-3112-25
Package NDCs from labels
0536-3112-25, 0536-3112-01, 0536-3112-37
Manufacturer
Rugby Laboratories
Effective date
2026-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine - Rugby LaboratoriesRugby Laboratories2026-07-16HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-3112-01Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 CARTONGUM, CHEWING1016
0536-3112-01Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016
0536-3112-37Rugby Nicotine Polacrilex Gum, Coated Mint Flavor4 in 1 CARTONGUM, CHEWING416
0536-3112-37Rugby Nicotine Polacrilex Gum, Coated Mint Flavor10 in 1 BLISTER PACKGUM, CHEWING1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-3112RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES, INC.]14Current NDC, Legacy NDC, 4 package rows20241127_621eb214-0716-4306-829f-6185a77f24d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3112-01EA - Each0536-31128ed7e80e-95d5-499d-be0f-180e50809ddb12013-02-13
0536-3112-37EA - Each0536-3112f7d9063f-e980-40ee-96a2-06d9741cb70512013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
NICOTINEACTIVE MOIETY6M3C89ZY6RRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ACACIAINACTIVE INGREDIENT5C5403N26ORUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933RUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QORUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TALCINACTIVE INGREDIENT7SEV7J4R1URUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPRUGBY NICOTINE POLACRILEX GUM, COATED MINT FLAVOR (NICOTINE POLACRILEX) GUM, CHEWING [RUGBY LABORATORIES]2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1ERUGBY NICOTINE POLACRILEX GUM, COATED 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 157 · 3,134 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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
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
BMNP ALUMINUM OXIDEALUMINUM OXIDETotal Operations Management LLC DBA:Bestmade Natural Products Micro5a5ad83a-0ecb-21fa-e063-6294a90a14222026-08-31WarningsExact identifier
unii: LMI26O6933
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

Reported adverse events (FAERS/openFDA)#

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