FDA.reportPublic FDA data

NDC 51672-1320 - 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
51672-1320
Package NDCs from labels
51672-1320-1
Manufacturer
Physicians Total Care, Inc.
Effective date
2010-08-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2010-08-10HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride Suppositories USP, 12.5 mg & 25 mgTaro Pharmaceuticals U.S.A., Inc.2008-09-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1320-1Promethazine Hydrochloride1 in 1 BOXSUPPOSITORY11
51672-1320-1Promethazine Hydrochloride12 in 1 BLISTER PACKSUPPOSITORY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1320PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]12 package rows20081030_3185D299-AB4C-4BF1-86A4-3C126144B245.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
ascorbyl palmitateINACTIVE INGREDIENTPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
ASCORBYL PALMITATEINACTIVE INGREDIENTQN83US2B0NPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
cocoa butterINACTIVE INGREDIENTPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRRPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]1
white waxINACTIVE INGREDIENTPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97FPROMETHAZINE HYDROCHLORIDE SUPPOSITORY [PHYSICIANS TOTAL CARE, INC.]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 38 · 760 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.