FDA.reportPublic FDA data

NDC 70000-0342-01 - Nicotine Polacrilex Coated Fruit

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
70000-0342
Requested NDC
70000-0342-01
Package NDCs from labels
70000-0342-1, 70000-0342-01
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Coated Fruit - CARDINAL HEALTH 110, LLC. DBA LEADER 70000CARDINAL HEALTH 110, LLC. DBA LEADER 700002026-04-10HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0342-1Nicotine PolacrilexCoated Fruit20 in 1 CARTONGUM, CHEWING2020
70000-0342-1Nicotine PolacrilexCoated Fruit1 in 1 BLISTER PACKGUM, CHEWING120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0342NICOTINE POLACRILEX COATED FRUIT (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]16Current NDC, Legacy NDC, 2 package rows20241116_d6c7a2ab-109d-40df-bce0-30c3531eb982.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0342-1EA - Each70000-0342e273d153-1f4f-4920-98d4-e86c85b2e76812018-11-06

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 73 of 149 · 2,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.a3f19365-d0d1-43ad-be15-48dc4320e3612025-12-06WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
Nicotine PolacrilexNICOTINE POLACRILEXRising Pharma Holdings, Inc.e86b9c22-7ee0-4bd0-adfd-a7b087b1dd712025-12-06WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC5d23992f-a010-4604-b64c-94ab6b134e6d2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
Alka-Seltzer HeartburnANHYDROUS CITRIC ACID, SODIUM BICARBONATE (HEAT-TREATED)Bayer HealthCare LLC.55158e50-0327-2043-e054-00144ff8d46c2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer Extra StrengthANHYDROUS CITRIC ACID, SODIUM BICARBONATE, AND ASPIRINBayer HealthCare LLC.49b73bd5-6465-05eb-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer GoldALKA-SELTZER GOLDBayer HealthCare LLC.0824bedb-413b-2fa0-e054-00144ff88e882025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATEBayer HealthCare LLC.5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc2025-12-04WarningsExact identifier
unii: 8MDF5V39QO
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
unii: 8MDF5V39QO
Quitine nicotineNICOTINE POLACRILEXQUITINE LLC90232b4e-cbf4-4d03-973a-41f4ebb4e5de2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
quitine mini nicotineNICOTINE POLACRILEXQUITINE LLC0781ddbd-45c4-4191-898a-50c71644965c2025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
QUITINE MINI NICOTINENICOTINE POLACRILEXQUITINE LLCd856379c-6334-4069-8382-ded2f86cf8a42025-12-04WarningsExact identifier
unii: 6M3C89ZY6R
NWRB Nicotine Transdermal PatchNICOTINEDongkou County Hecheng Network Technology Co., Ltd.44f3e697-1859-dab0-e063-6294a90a45172025-12-02WarningsExact identifier
unii: 6M3C89ZY6R
Omeprazole and Sodium BicarbonateOMEPRAZOLE AND SODIUM BICARBONATEAjanta Pharma USA Inc.bd84ca00-6352-4cb3-bce2-05f4a5005a942025-11-30Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
it cosmetics Bye Bye Foundation Full Coverage Moisturizer with 3D Skin Flex Broad Spectrum SPF 50 Plus UVA UVB Physical Sunscreen All ShadesTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA, Inc.86eea4df-4191-4e05-9f05-4a98ef8c2a4d2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATECivicaa10fdfbc-94a0-49ab-b26c-de1df042bc892025-11-24Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Cetaphil Sun Tinted Face SPF 40TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.22413f93-7219-4726-b741-2392e576b34a2025-11-24WarningsExact identifier
unii: 15FIX9V2JP
VEIL MINERAL PRIMER SUNSCREEN BROAD SPECTRUM SPF 15ZINC OXIDE AND TITANIUM DIOXIDEKingdom Animalia, LLC DBA Hourglass Cosmetics28e23498-953f-47c0-838c-bbf0e858d9032025-11-24WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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