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 3 of 152 · 3,023 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
sodium bicarbonateSODIUM BICARBONATEBaxter Healthcare Corporationb50c858a-00c8-4cb2-ad73-8797f19e656d2026-08-14Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
Mini NicotineNICOTINE POLACRILEXWALMART INC. (see also Equate)286e2768-ad98-43be-a3be-a2db0370f50f2026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
Nicotine MiniNICOTINE POLACRILEXWALMART INC. (see also Equate)b49546cd-6cc4-422c-9a72-3a1faf2abcd32026-08-12WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 46122a33b6ed6-2c75-4bab-98e5-a7f8bea219262026-08-12WarningsExact identifier
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
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DR. SAMRAO'S OFFICE58b2ca35-11ed-d848-e063-6294a90a5b372026-08-11WarningsExact identifier
unii: 15FIX9V2JP
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
NicotineNICOTINE POLACRILEXCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED9ba85e0a-bcb7-4803-8d21-0eb93768cb3a2026-08-07WarningsExact identifier
unii: 6M3C89ZY6R
Sodium BicarbonateSODIUM BICARBONATEMilla Pharmaceuticals Inc.2d2035c2-e41b-4d57-a23c-fae16ad9a3552026-08-07Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC1f93571c-4bd2-4272-ab9f-240b7c8a024b2026-08-06WarningsExact identifier
rxcui: 314119
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXP & L Development, LLC30e00817-75ff-43db-901c-c180e67309012026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
Quitine NicotineNICOTINE POLACRILEXQUITINE LLC4cc32b8c-6316-4d4b-8fa9-ef640464ca692026-08-06WarningsExact identifier
unii: 6M3C89ZY6R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
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.