FDA.reportPublic FDA data

NDC 51672-1319 - 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
51672-1319
Package NDCs from labels
51672-1319-1
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
51672-1319-1Promethazine Hydrochloride1 in 1 BOXSUPPOSITORY11
51672-1319-1Promethazine Hydrochloride12 in 1 BLISTER PACKSUPPOSITORY121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1319PROMETHAZINE 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 38 of 38 · 760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrate IIBERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUAZorex Internationale5f53495-3b75-4d7c-89af-23058fb6fd052018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
Dust Mix AntigenANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUSNatural Creations, Inc8dab4b4a-6fa8-4258-adc1-f8c634e2030b2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
Xyralid HemorrhoidalHEMORRHOIDAL SUPPOSITORIESInnovus Pharmaceuticals, Inc.8a885822-42e7-44e0-82d6-fa967123866e2018-05-03WarningsExact identifier
unii: 512OYT1CRR
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
ParathyroplexPARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEABioActive Nutritional, Inc.37649bb9-cbd7-4971-b410-18ea307c46f62017-04-18WarningsExact identifier
unii: ETJ7Z6XBU4
Arthritis JointsGNAPHALIUM POLYCEPHALUM, BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, BORAX, CUPRUM ACETICUM, KALI CARBONICUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, AMMONIUM MURIATICUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, GLANDULA SUPRARENALIS SUIS, MERCURIUS PRAECIPITATUS RUBER, SEPIA, ZINCUM METALLICUM, PALLADIUM METALLICUM, PICRICUM ACIDUM, SULPHUR, CARTILAGO SUIS, INTERVERTEBRAL DISC (SUIS), MEDULLA OSSIS SUISDeseret Biologicals, Inc.cec46d33-e106-481a-958d-b2aedabe18792017-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: ETJ7Z6XBU4
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEActavis Pharma, Inc.a32255f0-0077-489e-bdc6-869aca8cd4342016-12-01Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
0da34cd6-c336-4f3c-b29f-06a1eaae90ac6ad2e46c-c76b-4ca3-bfc7-9f903515b1b42010-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 0da34cd6-c336-4f3c-b29f-06a1eaae90ac
spl set id: 6ad2e46c-c76b-4ca3-bfc7-9f903515b1b4
32B67919-2312-7B62-E470-EAC328ED4B6F3185D299-AB4C-4BF1-86A4-3C126144B2452008-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 32B67919-2312-7B62-E470-EAC328ED4B6F
spl set id: 3185D299-AB4C-4BF1-86A4-3C126144B245

Reported adverse events (FAERS/openFDA)#

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