FDA.reportPublic FDA data

NDC 45802-089-01 - Nicotine Polacrilex

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
45802-089
Requested NDC
45802-089-01
Package NDCs from labels
45802-089-01, 45802-089-02
Manufacturer
Padagis Israel Pharmaceuticals Ltd
Effective date
2026-04-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Nicotine Polacrilex - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2026-04-30HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch PrepackBryant Ranch Prepack2025-07-29HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch PrepackBryant Ranch Prepack2025-04-03HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-089-01Nicotine Polacrilex27 in 1 CONTAINERLOZENGE274
45802-089-02Nicotine Polacrilex3 in 1 CARTONLOZENGE34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-089NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]3Current NDC, Legacy NDC, 2 package rows20250228_b765570e-e5b5-48e4-b4d2-2a85ac19a2ea.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-089-01EA - Each45802-0892761a663-9f19-4540-8d44-12ddfad2eee412026-05-22

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 30 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NicotineNICOTINE POLACRILEXMcKesson Corporation dba SKY Packaging0b6880c8-04e7-418a-98d1-0c7d19e025b32025-03-06WarningsExact identifier
unii: 6M3C89ZY6R
Bestmade Natural Products Nat CarbNATRUM CARBONICUMBestmade Natural Products2fa9c941-37c0-0b76-e063-6394a90af79e2025-03-06WarningsExact identifier
unii: 45P3261C7T
Bestmade Natural Products BM212ARS ALB, KALI PHOS, NAT CARB, NITRIC ACIDBestmade Natural Products2f37416e-b3af-f980-e063-6294a90a6be12025-02-28WarningsExact identifier
unii: 45P3261C7T
Fiber laxativeCALCIUM POLYCARBOPHILDiscount Drug Mart, Inc2e0c4736-3d27-e088-e063-6294a90aeca82025-02-27WarningsExact identifier
unii: 8F049NKY49
Maxi NicotineNICOTINE POLACRILEXCardinal Health (Leader) 70000362b4a04-4a5f-4af6-9cd7-82aa172b7afb2025-02-26WarningsExact identifier
unii: 6M3C89ZY6R
NicotineNICOTINE POLACRILEXThe Kroger Co.8c81c885-1d56-4dca-b9bc-adfc9bf580512025-02-25WarningsExact identifier
unii: 6M3C89ZY6R
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d22bedb-9f9d-8421-e053-2a95a90acf4a2025-02-10WarningsExact identifier
unii: 45P3261C7T
Stress-TensionCHAMOMILLA, HYPERICUM PERFORATUM, VALERIANA OFFICINALIS, ACONITUM NAPELLUS, ARGENTUM NITRICUM, AURUM METALLICUM, BAPTISIA, BRYONIA, CHELIDONIUM MAJUS, CIMICIFUGA RACEMOSA, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, LILIUM TIGRINUM, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PICRICUM ACIDUM, PLUMBUM METALLICUM, SEPIA, STAPHYSAGRIA, STRAMONIUM, THUJA OCCIDENTALIS, ZINCUM METALLICUM.Newton Laboratories, Inc.9d23e5da-4806-8ccc-e053-2995a90a19012025-02-10WarningsExact identifier
unii: 45P3261C7T
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: 6M3C89ZY6R
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.9d399697-69dc-217d-e053-2a95a90a65e42025-02-10WarningsExact identifier
unii: 6M3C89ZY6R
Bestmade Natural Products BM118ANACARDIUM ORI, ARSENIC ALB, AURUM MUR, KALI BROM, LYCOPODIUM, NATRUM CARB, NATRUM SULPH, PHOSPHORIC ACIDBestmade Natural Products2d90b08b-b65d-7d11-e063-6294a90a50922025-02-07WarningsExact identifier
unii: 45P3261C7T
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c3507de-1def-4019-e053-2a95a90a14752025-02-07WarningsExact identifier
unii: 45P3261C7T
Lymphatic CareECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9c36201a-2153-0600-e053-2995a90a6bbf2025-02-07WarningsExact identifier
unii: 45P3261C7T
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.7964f0f7-7774-fac6-e053-2a91aa0a3e4a2025-02-06WarningsExact identifier
unii: 45P3261C7T
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc307a2-4aa1-b02a-e053-2995a90a17882025-02-06WarningsExact identifier
unii: 45P3261C7T
Appetite - Craving ControlANACARDIUM ORIENTALE, ANTIMON.CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJUS, DIGITALIS, GRAPHITES, HUMULUS,IRIS VERSICOLOR, KALI CARB., LYCOPODIUM, NAT. CARB.,NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS. TOXICODENDRON, SCUTELLARIA LATERIFLORA, SEPIA,STRAMONIUM, CHAMOMILLA, PASSIFLORA, VALERIANA.Newton Laboratories, Inc.79655acc-f059-e509-e053-2a91aa0ac4882025-02-06WarningsExact identifier
unii: 45P3261C7T
Mini NicotineNICOTINE POLACRILEXEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9b1d9efc-f74b-42f5-be84-5142ee1687672025-01-30WarningsExact identifier
unii: 6M3C89ZY6R
Mini NicotineNICOTINE POLACRILEXAmerisourceBergen (Good Neighbor Pharmacy) 461227f1cdc21-d213-4ede-86fd-e11b31dfab582025-01-30WarningsExact identifier
unii: 6M3C89ZY6R
Tummy UpsetCHAMOMILLA, ECHINACEA, IRIS VERSICOLOR, RUTA GRAVEOLENS, TARAXACUM OFFICINALE, ALOE, ANGELICA SINENSIS RADIX, ANTIMONIUM , ARGENTUM NITRICUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BISMUTHUM METALLICUM, BRYONIA, CINCHONA OFFICINALIS, GRAPHITES, HYDRASTIS CANADENSIS, IPECACUANHA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MYRRHA, NATRUM CARBONICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA, ZINGIBER OFFICINALE.Newton Laboratories, Inc.9dc2da0a-0b3a-548e-e053-2995a90abe6d2025-01-28WarningsExact identifier
unii: 45P3261C7T
Fiber LaxativeCALCIUM POLYCARBOPHILTopco Associates, LLC0609468d-ee66-49af-be40-e51965b88f6f2025-01-20WarningsExact identifier
unii: 8F049NKY49

Reported adverse events (FAERS/openFDA)#

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