FDA.reportPublic FDA data

NDC 45802-758-00 - Promethazine Hydrochloride

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
45802-758
Requested NDC
45802-758-00
Package NDCs from labels
45802-758-00, 45802-758-30
Manufacturer
A-S Medication Solutions
Effective date
2025-12-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - A-S Medication SolutionsA-S Medication Solutions2025-12-04HUMAN PRESCRIPTION DRUG LABEL
ASCORBYL PALMITATE - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-06-07HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-01-18HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2023-06-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-758-00Promethazine Hydrochloride1 in 1 BLISTER PACKSUPPOSITORY116
45802-758-30Promethazine Hydrochloride12 in 1 CARTONSUPPOSITORY1216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-758PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PADAGIS ISRAEL PHARMACEUTICALS LTD]16Current NDC, Legacy NDC, 2 package rows20250522_047b9a7c-586b-4635-a63e-2c7ce9ec34e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-758-00EA - Each45802-758d43ae8f7-a810-4e93-b3f9-657311daee7112015-03-03
45802-758-30EA - Each45802-758624cc3a1-3377-4222-943b-7dec9c05408812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PERRIGO NEW YORK INC]5

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 38 · 760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SKIN BALANCECALC SULPH, KALI SULPH, SILICEAZettl Health Inc.54012f03-4c34-42f5-e063-6394a90aacc52026-06-11WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCBM Private Limited53e763ee-9a44-a914-e063-6394a90aeb3c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
GUNA-AWARENESSBETAINE - BUFO BUFO CUTANEOUS GLAND - CALCIUM CARBONATE - CHROMIC SULFATE - CICUTA VIROSA ROOT - COPPER - FOLIC ACID - GOLD - COBALAMIN - IRON - LACHESIS MUTA VENOM - MELATONIN - MOLYBDENUM - NEUROTROPHIN-3 - NEUROTROPHIN-4 - OXYTOCIN - SILICON DIOXIDE - SUS SCROFA FRONTAL LOBE - SUS SCROFA TEMPORAL LOBE - THYROTROPIN ALFA - UBIDECARENONE - VANADIUM - ZINC - BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN -Guna spa10e46b39-7903-4390-b72d-865291245b4c2026-06-10WarningsExact identifier
unii: ETJ7Z6XBU4
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECamber Pharmaceuticals, Inc.6a2cd2d6-6e0f-4b2d-be7a-8b99627f44532026-06-09Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited53d1c51a-77eb-bb3c-e063-6394a90aab3f2026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d3c1d6-d0ba-5ea7-e063-6394a90a02942026-06-09WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro53bb3927-6053-eb3d-e063-6394a90a5ddf2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
ScrofularoforceRUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANABioActive Nutritional, Inc.737cd410-0405-41b0-b7f2-29bb200378492026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacke6d940f8-fa1a-4a75-b4fc-2cbbaf7a04882026-06-05Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackf9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c472026-06-04Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
Free RadicalACETALDEHYDE, ALFALFA, ALPHA-KETOGLUTARICUM ACIDUM, ALPHA-LIPOICUM ACIDUM, ASCORBYL PALMITATE, COBALTUM METALLICUM, CYSTEINUM, DIMETHYL GLYCINE, FERRUM METALLICUM, FUCUS VESICULOSUS, GABA (GAMMA AMINOBUTYRIC ACID), GLUTATHIONE, HORDEUM VULGARE, L-METHIONINE, MAGNESIUM FLUORATUM, MANGANESE GLUCONATE, NASTURTIUM AQUATICUM, ORYZA SATIVA, QUERCETIN, RAPHANUS SATIVUS, SELENIUM METALLICUM, SODIUM SELENITE, TRITICUM AESTIVUM, UBIDECARENONUM, VITAMIN E, ZINC PICOLINATE, ZINCUM METALLICUMDeseret Biologicals, Inc.2408a38a-9cdd-48c0-b76c-b72e4fe5d7192026-06-02WarningsExact identifier
unii: QN83US2B0N
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5ce082e9-13eb-4e63-a9e2-657d3ef0e9f82026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.f93ca67d-362a-473f-8296-2952da77c0742026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d2026-05-22Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
DentaforceANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUMBioActive Nutritional, Inc.82321547-e04a-42ff-aa39-6a192638e5a22026-05-18WarningsExact identifier
unii: ETJ7Z6XBU4
C07 STRONG LIGAMENTS AND JOINTSARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALEApex Energetics Inc.bccf8c83-a6cd-e58c-e053-2a95a90a43d72026-05-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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