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 3 of 283 · 5,646 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ActivICEMENTHOLMedline Industries, LP834adeb9-38ad-0cfe-e053-2991aa0af82f2026-09-01WarningsExact identifier
unii: L7T10EIP3A
La Vaquita New ExtraMETHYL SALICYLATE, MENTHOLDelon Laboratories (1990) Ltd3097a01b-cee5-492f-b65a-63992fb28e3a2026-09-01WarningsExact identifier
unii: L7T10EIP3A
MUCINEX INSTASOOTHE SORE THROAT PLUS COUGH SUGAR FREEHEXYLRESORCINOL AND MENTHOLReckitt Benckiser LLC4a938e15-a996-8538-e063-6294a90ad4ee2026-09-01WarningsExact identifier
unii: L7T10EIP3A
up and up citrus mini nicotineNICOTINE POLACRILEXTarget Corporation7457f30e-0281-49db-91e0-ddaedaa6b2572026-09-01WarningsExact identifier
unii: 6M3C89ZY6R
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLWALMART INC. (see also Equate)ceb125d9-8c1b-498c-b0f0-f18756ede4422026-09-01WarningsExact identifier
unii: L7T10EIP3A
NICOTINE MININICOTINE POLACRILEXAmazon.com Services LLCd6f7dea2-6375-4057-8947-314a429fa4922026-09-01WarningsExact identifier
unii: 6M3C89ZY6R
Kids AntacidCALCIUM CARBONATETHE KROGER CO.d77c629b-5308-4b71-9024-9899cf88dbae2026-09-01WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Smooth Antacid Assorted BerryCALCIUM CARBONATEKROGER COMPANY4c8d39d9-9d58-45df-9ffd-2cdc41539c032026-09-01WarningsExact identifier
unii: H0G9379FGK
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
unii: H0G9379FGK
Orajel 4X Medicated Toothache and Gum CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1c82b4-02b3-d456-e063-6294a90a16bb2026-08-31WarningsExact identifier
unii: L7T10EIP3A
Orajel 4X Medicated Toothache and Gum PM CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.5a1cdaf4-3388-280c-e063-6294a90ac70f2026-08-31WarningsExact identifier
unii: L7T10EIP3A
REINREUDE SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a539219-f9b8-5e94-e063-6294a90a25932026-08-31WarningsExact identifier
unii: L7T10EIP3A
SERYNTH SMELLING SALTSMENTHOL 15% SMELLING SALTSHubei Minxin Pharmaceutical Co., Ltd.5a5405f9-9881-e547-e063-6294a90a0d102026-08-31WarningsExact identifier
unii: L7T10EIP3A
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
unii: H0G9379FGK
QUITINE NICOTINENICOTINE POLACRILEXQUITINE LLC2e24f6d7-957e-4c7c-a486-8a1c1b47d53f2026-08-31WarningsExact identifier
unii: 6M3C89ZY6R
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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