FDA.reportPublic FDA data

NDC 0135-0510-05 - NICORETTE

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
0135-0510
Requested NDC
0135-0510-05
Package NDCs from labels
0135-0510-01, 0135-0510-06, 0135-0510-07, 0135-0510-05
Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
NICORETTE - Haleon US Holdings LLCHaleon US Holdings LLC2024-03-21HUMAN OTC DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0135-0510-012020-11-16Drug Facts
0135-0510-062020-11-16Drug Facts
0135-0510-072020-11-16Drug Facts
0135-0510-012020-01-31Drug Facts
0135-0510-062020-01-31Drug Facts
0135-0510-072020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0510-01NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-01NICORETTE3 in 1 CARTONLOZENGE320
0135-0510-06NICORETTE1 in 1 CARTONLOZENGE120
0135-0510-06NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-07NICORETTE24 in 1 CONTAINERLOZENGE2420
0135-0510-07NICORETTE6 in 1 CARTONLOZENGE620

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0510NICORETTE (NICOTINE POLACRILEX) LOZENGE [HALEON US HOLDINGS LLC]20Current NDC, Legacy NDC, 6 package rows20240322_991704ed-781a-489b-8b56-0b558e8fc385.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0510-01EA - Each0135-0510f0ffc1c3-e692-4905-aa88-2faaadb4753112012-07-24
0135-0510-02EA - Each0135-05109ee598da-64eb-4003-8a5c-0d14031d685112012-07-24
0135-0510-03EA - Each0135-051054781fa4-261f-4ce0-a75f-73ff3363547312014-05-02
0135-0510-05EA - Each0135-05105be5cc82-ba49-45eb-898e-05ba8dfcad3312012-07-24
0135-0510-06EA - Each0135-05106b500f22-c3c2-40fb-af1c-142d8b79420d12016-06-14
0135-0510-07EA - Each0135-05104a75b975-1405-40dc-883f-9d90afcdeb0f12016-05-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
NICOTINEACTIVE MOIETY6M3C89ZY6RNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACACIAINACTIVE INGREDIENT5C5403N26ONICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CALCIUM POLYCARBOPHILINACTIVE INGREDIENT8F049NKY49NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
EUGENOLINACTIVE INGREDIENT3T8H1794QWNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MANNITOLINACTIVE INGREDIENT3OWL53L36ANICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)INACTIVE INGREDIENT461P5CJN6TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
PALM KERNEL OILINACTIVE INGREDIENTB0S90M0233NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POLACRILININACTIVE INGREDIENTRCZ785HI7SNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
POTASSIUM BICARBONATEINACTIVE INGREDIENTHM5Z15LEBNNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5NICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMNICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEENICORETTE (NICOTINE POLACRILEX) LOZENGE [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]10

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 2 of 41 · 813 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXWalgreensd933d32c-cb4a-41b2-9563-da74cf2d77e42026-08-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXWalgreens97ce52b1-d98e-4216-99c2-7e341c8fec432026-08-25WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmazon.com Services LLC4ab742f2-2599-4d9f-83c5-9338d66ad6cf2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXCardinal Health 107, LLCebab2c3a-4fda-40d6-8f54-972e1c6ee69a2026-08-24WarningsExact identifier
unii: 6M3C89ZY6R
Quit smoking patchesQUIT SMOKING PATCHESShenzhen yuehaotong Technology Co., Ltd59b0c0e9-dc03-ec1e-e063-6394a90a8a872026-08-23WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCb957f757-2b34-49b2-a68b-a7bc9e8dd8b22026-08-21WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
unii: 6M3C89ZY6R
NICOTINENICOTINE POLACRILEXWalgreen Company5dd116ea-d031-439c-b06c-2f77230bc4462026-08-20WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCe40a534e-8083-454d-9667-826bfbac397c2026-08-19WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
nicotineNICOTINE POLACRILEXAmazon.com Services LLCbc1b6b41-d069-470e-90ca-a441ab97f96a2026-08-18WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
FiberconCALCIUM POLYCARBOPHILMedtech Products Inc.59534afd-fe38-818a-e063-6394a90a21ea2026-08-18WarningsExact identifier
unii: 8F049NKY49
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: 45P3261C7T
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
rxcui: 359817
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC4cc32b8c-6316-4d4b-8fa9-ef640464ca692026-08-06WarningsExact identifier
rxcui: 359818
unii: 6M3C89ZY6R
NICOTINE GUMNICOTINE POLACRILEXGuangzhou Shuimu Jiahe Trading Co., Ltd.4e88dab4-8e13-f074-e063-6394a90a39082026-08-06WarningsExact identifier
unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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