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 4 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 506T60A25R
GB-ToneAMMI VIS, ATROPINUM SULPHURICUM, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, ECHINACEA, FEL TAURI, HEPAR SUIS, HYDRASTIS, LEPTANDRA, MAG PHOS, NAT PHOS, PODOPH PELT, TARAXACUMEnergetix Corporation1d857ae7-ad24-4f3b-8c33-f52851fa1ce62025-12-17WarningsExact identifier
unii: 03J5ZE7KA5
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEUnichem Pharmaceuticals (USA), Inc.5117f26c-488f-4ba6-b115-22baf12557f32025-12-11Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Diphenoxylate hydrochloride and atropine sulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEChartwell RX, LLC240b537e-ff9b-45e3-9398-584372bd707a2025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
AtropineATROPINE SULFATEAmneal Pharmaceuticals NY LLCf8718be5-8fa4-4c36-a4fd-fac7c3953f5a2025-12-04Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
atropine sulfateATROPINE SULFATEAmneal Pharmaceuticals LLC80a31286-a741-4440-b200-290c08925d062025-12-01Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATENorthStar RxLLCf750135c-e6bf-4aa7-a343-87b1204df94f2025-11-12Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
43405f94-13c3-0096-e063-6394a90a0488396ea336-9db3-6d4e-e063-6294a90aee632025-11-10Exact identifier
spl id: 43405f94-13c3-0096-e063-6394a90a0488
spl set id: 396ea336-9db3-6d4e-e063-6294a90aee63
MotofenDIFENOXIN AND ATROPINE SULFATESebela Pharmaceuticals Inc.4cd3f029-a5e3-5812-e054-00144ff8d46c2025-11-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Sorbitol-MannitolSORBITOL AND MANNITOLICU Medical Inc.5b44e248-4b7b-4777-954a-921c7b3099442025-10-30Warnings, Adverse reactionsExact identifier
unii: 506T60A25R
Atropine SulfateATROPINE SULFATE MONOHYDRATEMedical Purchasing Solutions, LLC423fc064-57cb-8308-e063-6394a90a26172025-10-28Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Incb753894e-81f8-4e81-b07a-c338311ded5b2025-10-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
OFTAL-MYCIN LUBRICANT OPHTHALMICLIGHT MINERAL, WHITE PETROLATUMGRANDALL DISTRIBUTING, LLC298db04a-21a9-e46e-e063-6294a90acee22025-10-27WarningsExact identifier
unii: N6K5787QVP
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.6acb3f07-9e32-4ad0-8336-e2f33d55b1272025-10-27Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Sugar CravingsCINNAMIC ACID, PHLORIDZINUM, ARGENTUM NITRICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, BEET SUGAR, DEXTROSE, D-RIBOSE, FRUCTOSE, LYCOPODIUM CLAVATUM, MAPLE SUGAR, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, MALVIN, ADRENOCORTICOTROPHIN, DYSENTERY BACILLUS, MORGAN GAERTNERDr. Donna Restivo DC401873ba-ae1b-4506-a2e8-c6c0e5ff27f52025-10-21WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATELifestar Pharma LLCb5f78b2a-56d1-4400-9d2f-b033cc13d26e2025-10-13Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHikma Pharmaceuticals USA Inc.a66eecf9-2d8b-4e2d-8a05-d718dcbc35422025-10-08Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
ATROPINE SULFATEATROPINE SULFATEAccord Healthcare, Inc.,c82cb295-ffce-47d6-97ad-a8aa723f4e4f2025-10-06Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEMedical Purchasing Solutions, LLC3fa81939-4495-28d5-e063-6394a90a1f2d2025-09-25Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution3ef1a1a0-93c1-e6b6-e063-6294a90aa2b62025-09-17Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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