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 1 of 272 · 5,439 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HERA SILKYSTAY FOUNDATION 37W1TITANIUM DIOXIDEAmorepacific Corporation5f4105f3-d08b-edb5-e063-6394a90ad28b2026-11-01WarningsExact identifier
unii: 15FIX9V2JP
Dr SabharwalsMENTHOL 5% PATCHDr. Sabharwal's Wound Care1025b986-a1e5-701d-e063-6294a90a33fd2026-10-28WarningsExact identifier
unii: L7T10EIP3A
HEB Cherry Cough DropsMENTHOLHEBc198e3c7-5ba7-ece6-e053-2995a90adb382026-10-27WarningsExact identifier
unii: L7T10EIP3A
HERA SILKYSTAY FOUNDATION 28O1TITANIUM DIOXIDEAmorepacific Corporation5ec77f7a-4621-ac0c-e063-6294a90a3f702026-10-26WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 50 (Light)TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health Inc.4f8756bf-5b0d-5269-e063-6294a90ae6dc2026-10-02WarningsExact identifier
unii: 15FIX9V2JP
NICOTINENICOTINE POLACRILEXSafeway473501c3-70d4-40fd-bc44-1b750fd1771b2026-09-21WarningsExact identifier
unii: 6M3C89ZY6R
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)9a9c5c6b-94fe-484a-a879-12c29cbdefe42026-09-11WarningsExact identifier
unii: L7T10EIP3A
NicotineNICOTINE POLACRILEXAmazon.com Services LLCda4c5203-76d7-454f-85bd-1717d95506bd2026-09-09WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
unii: H0G9379FGK
OTTFFSS SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5b0991b6-59cc-59b3-e063-6394a90a76932026-09-09WarningsExact identifier
unii: L7T10EIP3A
THITFAM SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a78d096-4740-8dd4-e063-6294a90a651f2026-09-09WarningsExact identifier
unii: L7T10EIP3A
Magic CreamPAIN RELIEVING OINTMENTJiangxi Baikang Medical Products Co., Ltd.5b0f2515-47e9-603f-e063-6294a90af9d42026-09-09WarningsExact identifier
unii: L7T10EIP3A
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Good Sense NicotineNICOTINE POLACRILEXL. Perrigo Companyae802de5-8e1b-439f-ab81-db4bd7241c912026-09-09WarningsExact identifier
rxcui: 311975
unii: 6M3C89ZY6R
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
unii: H0G9379FGK
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
unii: H0G9379FGK
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
unii: H0G9379FGK
Nerve Guard Nerve ReliefLIDOCAINE HYDROCHLORIDE, MENTHOL,MAGNESIUM CHLORIDEMicelle Laboratories, Incorporated6b78f40f-2a7f-4c49-96af-1a95acbf430f2026-09-04WarningsExact identifier
unii: L7T10EIP3A
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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