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 83 of 149 · 2,965 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equate nicotineNICOTINE POLACRILEXWal-Mart Stores Inc04f2b325-2243-4c6f-880c-45f2543091da2025-09-12WarningsExact identifier
unii: 6M3C89ZY6R
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
sunscreenTITANIUM DIOXIDE(NANO)Mingyu (guangdong) Cosmetics Technology Co., Ltd3e6fe9f3-486b-bba7-e063-6294a90adf372025-09-10WarningsExact identifier
unii: 15FIX9V2JP
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dbb07e2-971c-284d-e063-6294a90a437f2025-09-06WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE,HOMOSALATE ,OCTINOXATE ,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3e069cb2-c4c5-abf5-e063-6394a90a56b02025-09-06WarningsExact identifier
unii: 15FIX9V2JP
omeprazole and sodium bicarbonateOMEPRAZOLE, SODIUM BICARBONATEMeijer Distribution Incbb7c1c5d-b915-42f5-a5a2-5f61b088028d2025-09-05WarningsExact identifier
unii: 8MDF5V39QO
PowderTITANIUM DIOXIDEOxygen Development LLC08b52f29-c1a0-c673-e063-6294a90a9a7a2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b8003f-40be-3380-e063-6294a90a4f6b2025-09-05WarningsExact identifier
unii: 15FIX9V2JP
stop smoking aidNICOTINE POLACRILEXPublix Super Markets Inc63d4ceab-2474-49cd-bb4f-63728eee6ac52025-09-05WarningsExact identifier
unii: 6M3C89ZY6R
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PHOFAY Matte Sunscreen Liquid Foundation SPF 30, 1ENSULIZOLE, HOMOSALATE, OCTINOXATE, TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.18130858-429c-4ed4-a75b-5bc0144812502025-09-04WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 38C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L0358a87d-8002-4f3e-851a-3a582d356edf2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 39N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L34dfc4c5-44f7-4531-97ba-8846ebe147242025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
unii: 15FIX9V2JP
Mini NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.237471f8-ce0f-423b-993f-b4380fd890ff2025-09-02WarningsExact identifier
unii: 6M3C89ZY6R
Sodium Bicarbonate 10 GR (650 MG)SODIUM BICARBONATEAdvanced Rx LLC634e8d52-6d04-42f9-98f6-2634473b5dfd2025-09-01WarningsExact identifier
unii: 8MDF5V39QO
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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