FDA.reportPublic FDA data

NDC 45802-759-00 - 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
45802-759
Requested NDC
45802-759-00
Package NDCs from labels
45802-759-00, 45802-759-30
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
Promethazine Hydrochloride Suppositories USP, 25 mgPD-Rx Pharmaceuticals, Inc.2025-10-15HUMAN 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 Prepack2024-01-11HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Padagis Israel Pharmaceuticals LtdPadagis Israel Pharmaceuticals Ltd2023-06-30HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Rebel Distributors CorpRebel Distributors Corp2010-11-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-759-00Promethazine Hydrochloride1 in 1 BLISTER PACKSUPPOSITORY116
45802-759-30Promethazine Hydrochloride12 in 1 CARTONSUPPOSITORY1216

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-759PROMETHAZINE 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
45802-759-00EA - Each45802-759746555d8-d089-4d29-a28c-93926f76a56112015-03-03
45802-759-30EA - Each45802-75956ac9144-d794-49de-ad4a-1141c6e43e6112012-07-24

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
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PD-RX PHARMACEUTICALS, INC.]3
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [REBEL DISTRIBUTORS CORP]1

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 3 of 39 · 761 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECoupler LLC55f618d1-4466-3200-e063-6394a90a89a82026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEREMEDYREPACK INC.9e4e57fa-4ce3-4b7b-be5a-381801ed03862026-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDESportpharm LLC4156e780-7ecf-bcae-e063-6394a90a2ae22026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEASCLEMED USA INC.4d30e587-6d59-4cf5-ab45-c7639f759df92026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa StannumBAMBUSA STANNUMUriel Pharmacy Inc.a0d4d0ac-e2d2-4381-8f93-e417195218592026-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.804e2525-d61f-7bed-e053-2991aa0a5daa2026-06-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAdvagen Pharma Ltd8b60eff2-5759-4bc3-ac16-5ff80aa153a02026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
unii: 512OYT1CRR
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM5 DROPSAPIS MELL, BAPTISIA, CONIUM MAC, ECHINACEA, EUPATORIUM PERF, SILICEA, THUJA OCCTotal Operations Management LLC DBA:Bestmade Natural Products Micro540e4ee3-596f-4cea-e063-6294a90a6a602026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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