FDA.reportPublic FDA data

NDC 55466-783 - LOMOTIL

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
55466-783
Package NDCs from labels
55466-783-16
Manufacturer
Neolpharma, Inc.
Effective date
2025-11-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Diphenoxylate Hydrochloride and Atropine Sulfate Tablets - Neolpharma, Inc.Neolpharma, Inc.2025-11-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55466-783-16LOMOTIL250 in 1 BOTTLETABLET2502

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 8 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cand PlusHYDRASTIS CANADENSIS, BERBERIS VULGARIS, BORAX, SACCHARUM OFFICINALE, CAFFEINUM, GALLICUM ACIDUM, INDOLUM, ALLIUM SATIVUM, ECHINACEA (ANGUSTIFOLIA), ASAFOETIDA, ACETALDEHYDE, FOLLICULINUM, LYCOPODIUM CLAVATUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), SEPIA, USTILAGO MAIDIS, TORULA CEREVISIAEDeseret Biologicals, Inc.1f8ab864-27c2-4457-8ad7-5d65f9983e2c2024-03-06WarningsExact identifier
unii: C151H8M554
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst0060b971-19bd-2849-e063-6294a90afca82024-01-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirste9fd624a-9abd-dfea-e053-2a95a90a8e9d2024-01-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co., LLC, DBA Health First73de9878-a08a-4966-e053-2a91aa0ab0f62024-01-25Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine sulfateATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirst007728fc-f4cb-d519-e063-6394a90ae0332024-01-22Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEHF Acquisition Co LLC, DBA HealthFirstc0d0ca2a-4267-41b7-e053-2a95a90a47262024-01-22Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
A04 DEEP ANTITOXALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUMApex Energetics Inc.b9bbbddf-b822-4780-e053-2a95a90afbba2024-01-08WarningsExact identifier
unii: C151H8M554
A09 FEMALE BALANCEARGENTUM NITRICUM, ATROPINUM SULPHURICUM, AURUM MURIATICUM NATRONATUM, BOS TAURUS OVARY, BOS TAURUS PANCREAS, BOS TAURUS PITUITARUM POSTERIUM, BOS TAURUS UTERUS, CIMICIFUGA RACEMOSA, ESTRONE, HELONIAS DIOICA, PROGESTERONE, PULSATILLA VULGARIS, SABINA, SEPIA, SEQUOIADENDRON GIGANTEUM WHOLE, SUS SCROFA PINEAL GLAND, SUS SCROFA SPLEEN, THIOSINAMINUM, THYROIDINUM, VIBURNUM OPULUSApex Energetics Inc.b8e1ba2a-f80f-158e-e053-2a95a90aacd12024-01-08WarningsExact identifier
unii: 03J5ZE7KA5
B05 GLUCO BALANCEADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUMApex Energetics Inc.bae9ff7e-eb69-c61d-e053-2995a90a26272024-01-08WarningsExact identifier
unii: C151H8M554
AtropineATROPINE SULFATEA-S Medication Solutions1b2d030e-c0ec-484b-a228-76011702cdd02024-01-02Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC0aab13de-04bf-2a14-e063-6294a90aae112023-11-15Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Saccharum officinaleSUCROSEBoiron86d04552-b31a-0fcf-e053-2991aa0acecd2023-11-14Exact identifier
unii: C151H8M554
Saccharum officinaleSUCROSEBoiron86d05561-6f09-6f1f-e053-2a91aa0a4b982023-11-14Exact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC09d086f2-db9a-5e15-e063-6394a90abe182023-11-10Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
BHI Spasm PainATROPINE SULFATE, ACONITUM NAPELLUS, BRYONIA ALBA ROOT, CITRULLUS COLOCYNTHIS FRUIT PULP, AND CUPRIC SULFATEMediNatura Inc3e117ea6-bbb2-4b77-b3ce-01572e6d71c12023-09-28WarningsExact identifier
unii: 03J5ZE7KA5
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.0631d5e5-9da4-bcb7-e063-6394a90a62de2023-09-25WarningsExact identifier
unii: C151H8M554
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 506T60A25R
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: 506T60A25R
Hepaticol SarcodeCARDUUS MARIANUS, ZINGIBER OFFICINALE, BERBERIS VULGARIS, CHELIDONIUM MAJUS, MAGNESIA MURIATICA, LEPTANDRA VIRGINICA, NATRUM MURIATICUM, BRYONIA (ALBA), HEPAR (BOVINE), NATRUM SULPHURICUM, ATROPINUM SULPHURICUM, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f9d95b2f-53d9-4017-873f-5ad0b129f9f82023-08-14WarningsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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