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 5 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atropine SulfateATROPINE SULFATE INJECTIONProPharma Distribution3eeed115-0e17-c4b2-e063-6294a90a29b72025-09-16Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEProPharma Distribution3eef6300-9c78-82b2-e063-6294a90a54992025-09-16Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMHanlim Pharm Co. , LTD3b329232-a562-6893-e063-6394a90aa41f2025-07-31WarningsExact identifier
unii: N6K5787QVP
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEAmerican Health Packagingd0a1c80d-6aae-4886-8c25-e2d29ca0836b2025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
LubriFresh PMLIGHT MINERAL OIL, WHITE PETROLATUMMajor Pharmaceuticals3ab32e69-b8da-f187-e063-6294a90afa9a2025-07-24WarningsExact identifier
unii: N6K5787QVP
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Eyeleve MGDMINERAL OILBruder Healthcare145b66e2-00e1-410e-8539-e12ffc4f6f822025-07-15WarningsExact identifier
unii: N6K5787QVP
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsExact identifier
unii: W24OD7YW48
unii: 03J5ZE7KA5
Steritalc 2gTALCNovatech SAc94e51d9-beef-4b06-e053-2a95a90a754a2025-06-25Warnings, Adverse reactionsExact identifier
unii: 7SEV7J4R1U
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 506T60A25R
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
Atropine sulfateATROPINE SULFATESomerset Therapeutics, LLCe30491ed-938e-4ef4-aa23-a2e94cbab0ed2025-05-29Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEPD-Rx Pharmaceuticals, Inc.700aad61-fa8c-4ded-87b8-da966093075a2025-04-17Warnings, Adverse reactionsExact identifier
rxcui: 1190572
unii: W24OD7YW48
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEHenry Schein, Inc.d4839e54-b350-4643-8e6e-f0437f5349d62025-04-17Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Atropine SulfateATROPINE SULFATEBausch & Lomb Incorporatedaeab333c-3cdb-45c0-9e22-949624d69fbc2025-04-14Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
Leader Nighttime Relief Lubricant EyeLIGHT MINERAL OIL, WHITE PETROLATUMLEADER/Cardinal Health 110, Inc.308772fc-d6f6-da9f-e063-6394a90a41db2025-03-12WarningsExact identifier
unii: N6K5787QVP
AlcostatTARAXACUM OFFICINALE, AVENA SATIVA, PASSIFLORA INCARNATA, AURUM METALLICUM, CAPSICUM ANNUUM, CHELIDONIUM MAJUS, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NOX VOMICA, QUERCUS GLANDIUM SPIRITUS, SULPHURICUM ACIDUM, ETHYLICUM, CARCINOSIN, SACCHARUM OFFICINALEEnergique, Inc.77daea02-3c32-4ba3-a7a8-af79b13ddc062025-02-27WarningsExact identifier
unii: C151H8M554
Atropine SulfateATROPINE SULFATEInternational Medication Systems, Limitedb72d0a82-6163-460f-965a-12f6da47370a2025-01-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5

Reported adverse events (FAERS/openFDA)#

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