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 18 of 38 · 760 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cell SaltsCALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEANewton Laboratories, Inc.7a1a9ef9-9a54-5f94-e053-2a91aa0ab4772025-07-24WarningsExact identifier
unii: ETJ7Z6XBU4
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: ETJ7Z6XBU4
DENTAL-CHORDACETICUM ACIDUM, AMMONIUM MURIATICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARBOLICUM ACIDUM, CITRUS LIMONUM, CUPRUM METALLICUM, FERRUM METALLICUM, GLYCYRRHIZA GLABRA, LAPPA MAJOR, MEDULLA OSSIS SUIS, MERCURIUS SOLUBILIS, MYRRHA, NATRUM FLUORATUM, PALLADIUM METALLICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SELENIUM METALLICUM, SILICEA, STANNUM METALLICUM, STAPHYSAGRIA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, X-RAY, ZINCUM OXYDATUMEnergetix Corporation6c9ba926-7c35-49fd-94d8-988ca0bb772c2025-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
unii: 512OYT1CRR
EndocrinpathALFALFA, BORAGO OFFICINALIS, CALCAREA CARBONICA, CEANOTHUS AMERICANUS, CITRICUM ACIDUM, FUCUS VESICULOSUS, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYDROCOTYLE ASIATICA, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, PANCREAS SUIS, PHYTOLACCA DECANDRA, PITUITARUM POSTERIUM (BOVINE), SARSAPARILLA (SMILAX REGELII), SILICEA, SYZYGIUM JAMBOLANUM, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corporation70f84941-b8a1-48f4-9c05-554e554f00492025-07-11WarningsExact identifier
unii: ETJ7Z6XBU4
Schuessler Tissue Salts Silica 6X Cleanser and Conditioner 12SILICEAMartin & Pleasance Pty Ltd39620db9-5099-47f0-93ad-c00e6625c4622025-07-07WarningsExact identifier
unii: ETJ7Z6XBU4
Arnica Calendula WoundARNICA CALENDULA WOUNDUriel Pharmacy, Inc38cfd292-4dbd-2caf-e063-6394a90a05272025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.13d9e59d-eadb-41d5-9f47-9c11a6efb31c2025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d545105f-27dc-4820-b0b1-fcf17e0be0f02025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PHENERGANPROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.6f7e47cc-f823-4336-8107-f980e30496172025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
BacAPIS MELLIFERA, ARSENIC TRIOXIDE, ATROPA BELLADONNA, MATRICARIA CHAMOMILLA FLOWERING TOP OIL, LACHESIS MUTA VENOM, MERCURIUS SOLUBILIS, PULSATILLA VULGARIS WHOLE, TOXICODENDRON PUBESCENS LEAF, AND SILICON DIOXIDEZorex7ae38e0c-8e74-4fd5-8605-45e424a84d012025-06-30WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa AurumBAMBUSA AURUMUriel Pharmacy Inc.43f3dd30-701f-4fa4-9743-d10051c6e6d42025-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
foster and thrive hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLStrategic Sourcing Services LLCfb3bc359-b06b-4995-aa68-0117a639dff22025-06-11WarningsExact identifier
unii: 512OYT1CRR
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.1b1cee64-c0b5-4da6-92d0-1769350a51812025-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992454
rxcui: 992441
unii: R61ZEH7I1I
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
SLIMLYCOPODIUM CLAVATUM, ABIES CANADENSIS, AMMONIUM BROMATUM, AMMONIUM MURIATICUM, PHYTOLACCA DECANDRA, PULSATILLA (PRATENSIS), AMMONIUM CARBONICUM, FUCUS VESICULOSUS, CAPSICUM ANNUUM, ARGENTUM NITRICUM, KALI BICHROMICUM, SILICEA, GLANDULA SUPRARENALIS BOVINE, CALCAREA ARSENICICA, FERRUM METALLICUM, ANTIMONIUM CRUDUM, CALCAREA CARBONICA, GRAPHITES, KALI CARBONICUM, ANACARDIUM ORIENTALE, IODIUM, THYROIDINUM (SUIS), LEPTINThe Wellness Center for Research and Education5067953f-351e-4bb0-b165-8dc62077cdea2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
BioTox Dental Foci RepairARNICA MONTANA, HYPERICUM PERFORATUM, PLANTAGO MAJOR, ACONITUM NAPELLUS, MERCURIUS SOLUBILIS, HEKLA LAVA, ARGENTUM NITRICUM, BELLADONNA, HEPAR SULPHURIS CALCAREUM, SILICEAThe Wellness Center For Research and Education767f8dd2-759f-4662-9b5c-b8832309363d2025-06-06WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICEA 6XTrue Botanica, LLC2cee8f0b-6d28-75e4-e063-6294a90a2e152025-06-05WarningsExact identifier
unii: ETJ7Z6XBU4
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEATLANTIC BIOLOGICALS CORP.f8fb13e3-bc09-4004-a911-a38b6bbb00582025-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine DMPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEPAI Holdings, LLC dba PAI Pharma1d47280d-28c9-4701-8c5f-a6e6b524083b2025-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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