FDA.reportPublic FDA data

NDC 70000-0348-01 - Nicotine Polacrilex Coated Ice Mint

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
70000-0348
Requested NDC
70000-0348-01
Package NDCs from labels
70000-0348-1, 70000-0348-2, 70000-0348-01
Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Coated Ice Mint - CARDINAL HEALTH 110, LLC. DBA LEADER 70000CARDINAL HEALTH 110, LLC. DBA LEADER 700002026-04-13HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0348-1Nicotine PolacrilexCoated Ice Mint20 in 1 CARTONGUM, CHEWING2025
70000-0348-1Nicotine PolacrilexCoated Ice Mint1 in 1 BLISTER PACKGUM, CHEWING125
70000-0348-2Nicotine PolacrilexCoated Ice Mint100 in 1 CARTONGUM, CHEWING10025
70000-0348-2Nicotine PolacrilexCoated Ice Mint1 in 1 BLISTER PACKGUM, CHEWING125

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0348NICOTINE POLACRILEX COATED ICE MINT (NICOTINE POLACRILEX) GUM, CHEWING [CARDINAL HEALTH (LEADER) 70000]23Current NDC, Legacy NDC, 4 package rows20241122_b075c3cb-d610-4a9c-8cf0-e4b9001bc86a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0348-1EA - Each70000-034887d8a12d-3cbe-4deb-acb3-7323b2a029b612019-02-13
70000-0348-2EA - Each70000-0348d6d02b52-9395-41d9-9909-59e1044838dc12018-11-06

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 84 of 149 · 2,963 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 35W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L5440ed13-b07e-4c81-a407-d9ac68eaa4832025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 37W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L9b2c4567-fde7-4b76-9988-b2cba2d3747e2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Sodium BicarbonateSODIUM BICARBONATEProPharma Distribution3d71b046-3e0b-054a-e063-6294a90a563a2025-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d55291c-9d4c-85c3-e063-6394a90af3302025-08-27WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3d565612-ade5-bfb3-e063-6294a90a0c652025-08-27WarningsExact identifier
unii: 15FIX9V2JP
NicDuic Quit Smoking Nicotine PatchesNICOTINE TRANSDERMAL PATCHESShenzhen Paxi Trading Co., Ltd.3d5718f3-c175-6b64-e063-6394a90aa6f12025-08-27WarningsExact identifier
unii: 6M3C89ZY6R
Sun Bum 30 Mineral Tinted Sunscreen FaceTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a290aad-7f40-cb10-e063-6394a90a2e692025-08-27WarningsExact identifier
unii: 15FIX9V2JP
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacya275ff04-4078-4783-932b-dde9aee046822025-08-26WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine Sugar FreeNICOTINE POLACRILEXCVS Pharmacy63fce25d-457f-4048-86a4-1805f603936c2025-08-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXRite Aid Corporation9f77adad-4b67-48c8-9ad4-24bccdea3ae22025-08-26WarningsExact identifier
unii: 6M3C89ZY6R
Basic Care NicotineNICOTINE POLACRILEXAmazon.com Services LLC47561b44-572e-4ca0-b91c-db07061313632025-08-25WarningsExact identifier
unii: 6M3C89ZY6R
Maxi NicotineNICOTINE POLACRILEXRite Aid Corporation1472b0a3-5ff1-44e7-8748-a3b1a5e551962025-08-25WarningsExact identifier
unii: 6M3C89ZY6R
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3d0359b6-088f-aa54-e063-6394a90a422f2025-08-23WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3cdc1ae9-2924-5057-e063-6294a90ad2f32025-08-21WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDELongway Technology(Guangzhou) Co., Ltd.3b21f1d8-534d-f4ea-e063-6294a90ad2eb2025-08-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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