FDA.reportPublic FDA data

NDC 63443-5057-01 - Nicotine Polacrilex Gum

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
63443-5057
Requested NDC
63443-5057-01
Package NDCs from labels
63443-5057-1, 63443-5057-01
Manufacturer
Fertin Pharma A/S
Effective date
2026-02-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex Gum - Fertin Pharma A/SFertin Pharma A/S2026-02-18HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63443-5057-1Nicotine Polacrilex Gum10 in 1 CARTONGUM, CHEWING103
63443-5057-1Nicotine Polacrilex Gum10 in 1 BLISTER PACKGUM, CHEWING103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63443-5057NICOTINE POLACRILEX GUM (NICOTINE POLACRILEX) GUM, CHEWING [FERTIN PHARMA A/S]1Current NDC, Legacy NDC, 2 package rows20230106_f1774540-7c2f-c60b-e053-2995a90a1ccb.zip

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 283 · 5,646 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG HEALTH Liquid Antacid plus Anti GasCALCIUM CARBONATE, MAGNESIUM HYDROXIDE AND SIMETHICONEDOLGENCORP, LLC8ecb4418-e647-49b5-b418-1c63bb3e5a3c2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC4942747a-8b6c-422a-8150-9bd91c0a37782026-09-03WarningsExact identifier
unii: H0G9379FGK
nicotineNICOTINE POLACRILEXSixarp, LLC5a94092b-f80e-c656-e063-6294a90ab15a2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Equate Menthol Pain RelievingMENTHOLWal-Mart Stores Incd5b0a7f1-4e23-426b-bb7e-aaa251ad4ffc2026-09-03WarningsExact identifier
unii: L7T10EIP3A
ZHI TechnologiesLIDOCAINE, MENTHOLZHI Technologies, Inc.6717e995-4d2d-49e8-8ecf-7c62557dfdef2026-09-03WarningsExact identifier
unii: L7T10EIP3A
Nicotine MiniNICOTINE POLACRILEXHC Jones, Inc.80e9ee49-2b38-4b59-80a7-524021bf2b212026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
DG HEALTH Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLC13dd2758-a372-4b0e-bc99-56a2dacbf95f2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength Antacid Wintergreen flavorCALCIUM CARBONATEDOLGENCORP, LLCb84b3509-3178-4616-9bec-dad85a4f9d2a2026-09-03WarningsExact identifier
unii: H0G9379FGK
NICOTINENICOTINE POLACRILEXAmazon.com Services LLCec341a77-5b62-4980-8d31-27c12ae925612026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXHC Jones, Inc.ff9e34ff-5086-4e1b-9220-27ac2ac1069c2026-09-03WarningsExact identifier
unii: 6M3C89ZY6R
DG Health Regular Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC59ad3cc7-4144-442f-a37d-75c5fe23e1ae2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength Assorted Fruits AntacidCALCIUM CARBONATEDOLGENCORP, LLC112f1002-c007-4363-ade6-8dfbc61f4b642026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength AntacidSMOOTH DISSOLVE CALCIUM CARBONATEDOLGENCORP, LLCcabaa8f7-9c93-439d-905a-5ef643a08ea82026-09-03WarningsExact identifier
unii: H0G9379FGK
FREEZE EASE Roll-OnMENTHOLGlobal America Group LLC1869cc0d-a056-45de-aede-23b09b61ed122026-09-02WarningsExact identifier
unii: L7T10EIP3A
Nicotine Polacrilex Original FlavorNICOTINE POLACRILEXPublix Supermarkets, Inc.540c88bd-70dc-416a-8d8e-0a33b2b295632026-09-02WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Gaimoa Lidocaine Pain Relief Gel PatchesLIDOCAINE PAIN RELIEF GEL PATCHESHenan Enokon Medical Instrument Co., Ltd.5a68fe67-5c15-af9a-e063-6294a90a7ec12026-09-01WarningsExact identifier
unii: L7T10EIP3A
Ramedica Herbal Wonder BalmCAMPHOR, MENTHOLRamedicare Sdn. Bhd.cfb2ea0e-a1f6-4fdf-b866-346bbe78788f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New RegularMETHYL SALICYLATEDelon Laboratories (1990) Ltdd62186ac-afbb-443e-98c2-f0d122422a3c2026-09-01WarningsExact identifier
unii: L7T10EIP3A

Reported adverse events (FAERS/openFDA)#

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