NDC 45802-957-01 - 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: 45802-957
Requested NDC: 45802-957-01
Package NDCs from labels: 45802-957-01, 45802-957-02
Manufacturer: Padagis Israel Pharmaceuticals Ltd
Effective date: 2026-08-27
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Nicotine Polacrilex - Padagis Israel Pharmaceuticals Ltd	Padagis Israel Pharmaceuticals Ltd	2026-08-27	HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-07-29	HUMAN OTC DRUG LABEL
Nicotine Polacrilex - Bryant Ranch Prepack	Bryant Ranch Prepack	2025-04-03	HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45802-957-01	Nicotine Polacrilex	27 in 1 CONTAINER	LOZENGE	27		3
45802-957-02	Nicotine Polacrilex	3 in 1 CARTON	LOZENGE	3		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45802-957	NICOTINE POLACRILEX LOZENGE [PADAGIS ISRAEL PHARMACEUTICALS LTD]	3	Current NDC, Legacy NDC, 2 package rows	20250131_f6cc8d50-2d8d-4ed4-930a-a2479b1ebffe.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45802-957-01	EA - Each	45802-957	87ae052b-5a50-422c-8177-d36fa92b0e45	1	2025-02-10

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 39 of 40 · 783 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GUNA BOWEL PLUS	ACTIVATED CHARCOAL - ALOE - ALUMINUM OXIDE - BRYONIA ALBA ROOT - CHELIDONIUM MAJUS - COLLINSONIA - FRANGULA ALNUS BARK - LYCOPODIUM CLAVATUM SPORE - POTASSIUM CARBONATE- RHUBARB - STRYCHNOS NUX VOMICA SEED - SILYBUM MARIANUM SEED - SKATOLE - SODIUM CARBONATE - SUS SCROFA PANCREAS - TARAXACUM OFFICINALE - THIAMINE -	Guna spa	b3aa4fd3-c87a-ccd2-e053-2995a90a46a9	2021-01-17	Warnings	Exact identifier unii: 45P3261C7T
Real Relief	APIS MELLIFICA, ARNICA MONTANA, BENZOICUM ACIDUM, CAUSTICUM, COLCHICUM AUTUMNALE, NATRUM CARBONICUM	GMP Laboratories of America, Inc.	b7a1ce34-a996-22cf-e053-2a95a90afa45	2020-12-29	Warnings	Exact identifier unii: 45P3261C7T
Tobacco Withdrawal	ARSENICUM 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, VALERIANA	Newton Laboratories, Inc.	99eda7db-ce40-446f-e053-2995a90a95aa	2020-12-07	Warnings	Exact identifier unii: 6M3C89ZY6R
Intestia	ECHINACEA, IRIS VERSICOLOR, URTICA URENS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CINCHONA OFFICINALIS, COLLINSONIA CANADENSIS, DIOSCOREA VILLOSA, I ODIUM, IRIS VERSICOLOR, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PODOPHYLLUM PELTATUM, PULSATILLA, RHUS TOXICODENDRON, PYROGENIUM	Newton Laboratories, Inc.	9a132c99-7278-f667-e053-2a95a90a3d2b	2020-12-04	Warnings	Exact identifier unii: 45P3261C7T
Lymphatic Drainer	ECHINACEA, 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.	9a633bfa-188c-dd42-e053-2995a90ad3aa	2020-12-04	Warnings	Exact identifier unii: 45P3261C7T
Edema	ELAPS CORALLINUS, APIS MEL., ARSENICUM ALB., CANTHARIS, CINCHONA, COLCHICUM, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, JUNIPERUS COM., LACHESIS, MERC. VIV., NAJA, NAT. CARB., NAT.SULPHURICUM, RHUS TOXICODENDRON, SAMBUCUS NIG., STROPHANTHUS HISPIDUS, THUJA OCC., VIPERA BERUS, ECHINACEA, LAPPA, SOLIDAGO, TARAXACUM, URTICA UR.	Newton Laboratories, Inc.	98fbd4b0-43ac-098b-e053-2a95a90a6645	2020-12-03	Warnings	Exact identifier unii: 45P3261C7T
Appetite - Craving Control	CHAMOMILLA, PASSIFLORA, VALERIANA, ANACARDIUM, ANTIMON. CRUD., ARG. NIT., BERBER. VULG., BRYONIA, CHELIDONIUM MAJ., DIGITALIS, GRAPHITES, HUMULUS, IRIS VERS., KALI CARB., LYCOPODIUM, NAT. CARB., NAT. SULPHURICUM, NUX VOM., PULSATILLA, RHUS TOX., SCUTELLARIA, SEPIA, STRAMONIUM	Newton Laboratories, Inc.	98cf5293-2a47-5e15-e053-2995a90a9c3b	2020-12-02	Warnings	Exact identifier unii: 45P3261C7T
Connec-T	ECHINACEA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BERBERIS AQUIFOLIUM, CALCAREA FLUORICA, CAPSICUM ANNUUM, CARDUUS MARIANUS, CINCHONA OFFICINALIS, IODIUM, KALI CARBONICUM, LACHESIS MUTUS, MAGNESIA CARBONICA, MERCURIUS VIVUS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, SECALE CORNUTUM, THYMUS SERPYLLUM, THUJA OCCIDENTALIS, THYROIDINUM, VERBASCUM THAPSUS.	Newton Laboratories, Inc.	9a630923-1497-1fc8-e053-2995a90ad001	2020-12-02	Warnings	Exact identifier unii: 45P3261C7T
Distress-Mood-Sadness	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	98d0be75-9b50-1e15-e053-2995a90abf3b	2020-12-02	Warnings	Exact identifier unii: 45P3261C7T
Distress-Mood-Sadness	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	98d08917-2f1b-4dc7-e053-2a95a90a1ce0	2020-12-02	Warnings	Exact identifier unii: 45P3261C7T
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	79890e75-dfac-0262-e053-2a91aa0a5ce5	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Blues - Mood - Emotions	ANGELICA SINENSIS RADIX, ARALIA QUINQUEFOLIA, ARG. NIT., ARSENICUM ALB., BERBER. AQUI., CAPSICUM , CINCHONA, DIGITALIS, GELSEMIUM, HYPERICUM, IGNATIA, IODIUM, KALI BROM., KALI CARB., MAG. PHOS., NAT. CARB., NAT. MUR., PHOSPHORUS, SALIX NIGRA, SANGUINARIA, SEPIA, STRAMONIUM, ECHINACEA, GINKGO	Newton Laboratories, Inc.	798ab5a2-7464-8e9d-e053-2a91aa0acc98	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Cold Hands - Feet	HISTAMINUM HYDROCHLORICUM,THYROIDINUM, ACONITUM NAP., ARSENICUM ALB., BRYONIA, CACTUS, CALC. FLUOR., CEANOTHUS, CINCHONA, CONVALLARIA, DIGITALIS, GELSEMIUM, GLONOINUM, HYDROCOYLE, KALI CARB., LACHESIS, NAJA, NAT CARB., NAT MUR., NUX VOM., PHOSPHORUS, PULLSATILLA, RHUS TOXICODENDRON, STROPHANTHUS HISPIDUS, SULPHUR, ECHINACEA	Newton Laboratories, Inc.	7a2b4f28-2128-a8b2-e053-2a91aa0a2402	2020-11-24	Warnings	Exact identifier unii: 45P3261C7T
Effer-K Orange	POTASSIUM BICARBONATE	Nomax Inc.	bd402d91-d28d-49e9-9c1d-0983854773b3	2019-12-23	Warnings, Adverse reactions	Exact identifier unii: HM5Z15LEBN
Effer-K 20 mEq Unflavored	POTASSIUM BICARBONATE	Nomax Inc.	8869554b-ff0b-4f0e-8a09-61e7be3b496e	2019-12-18	Warnings, Adverse reactions	Exact identifier unii: HM5Z15LEBN
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	dc70703e-2c55-4178-a5d5-50f762ab6492	2019-04-24	Warnings	Exact identifier application number: ANDA203690 rxcui: 359818 unii: 6M3C89ZY6R
Nicotine	NICOTINE POLACRILEX	Meijer Distribution Inc	1d2cfb36-2d94-468c-8da1-6b6999b07d7b	2019-04-18	Warnings	Exact identifier application number: ANDA203690 unii: 6M3C89ZY6R
nicotine	NICOTINE	H E B	98633912-74d8-49db-a03e-4a3f882297ac	2019-04-17	Warnings	Exact identifier rxcui: 359818 unii: 6M3C89ZY6R
nicotine	NICOTINE	H E B	691f3f8d-7242-4855-b80b-4d5af0490b37	2019-04-16	Warnings	Exact identifier unii: 6M3C89ZY6R
signature care nicotine	NICOTINE POLACRILEX	Safeway	22010ed8-7fa6-402a-a314-523538183a55	2018-11-01	Warnings	Exact identifier application number: ANDA203690 unii: 6M3C89ZY6R

Reported adverse events (FAERS/openFDA)#

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