FDA.reportPublic FDA data

NDC 0641-6099-01 - 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
0641-6099
Requested NDC
0641-6099-01
Package NDCs from labels
0641-6099-01, 0641-6099-25
Manufacturer
West-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp
Effective date
2011-09-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE - West-ward Pharmaceutical Corp. | West-ward Pharmaceutical CorpWest-ward Pharmaceutical Corp. | West-ward Pharmaceutical Corp2011-09-15HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6099-252024-06-05C16284748780-1960f7f55-d58f-8e05-e053-dbdaa90a074aPromethazine Hydrochloride Injection, USP Rx only
0641-6099-252019-10-29C16284748780-1960f7f55-d58f-8e05-e053-dbdaa90a074aPromethazine Hydrochloride Injection, USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6099-01ML - Milliliter0641-609944485d47-ac32-4783-97cd-c5cb391cca8d12012-07-24
0641-6099-25ML - Milliliter0641-6099c055dafe-ee66-446f-963b-9f3d22150d8a12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]5
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]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 17 of 29 · 561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 4550K0SC9B
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
Calcium ChlorideCALCIUM CHLORIDECivica, Inc.7fa5d8e8-0610-4892-907e-5ef630a56e762024-11-08Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
Promethazine Hydrochloride and Phenylephrine HydrochloridePROMETHAZINE AND PHENYLEPHRINEAmneal Pharmaceuticals LLCcf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed42024-10-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEAmneal Pharmaceuticals LLC6081c216-0bed-40f0-8732-f999647003d52024-10-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals LLC05907a49-537f-4bf2-8a5f-5e905f19fece2024-10-30Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sore Throat Relief MentholPHENOLChain Drug Consortiumaf661ef0-cdc3-4146-8ae5-59795aa496502024-10-28WarningsExact identifier
unii: 339NCG44TV
Sore Throat Relief Cherry FlavorPHENOLChain Drug Consortiuma9cf9829-4b70-44fa-9719-240b65c067242024-10-28WarningsExact identifier
unii: 339NCG44TV
Chloraseptic Warming Sore ThroatPHENOLPrestige Brands Holdings, Inc.a197fab2-70ce-4a6c-9add-29d7368a75c52024-10-25WarningsExact identifier
unii: 339NCG44TV
Endopan HPACETICUM ACIDUM, COLCHICUM AUTUMNALE, LACTICUM ACIDUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SYZYGIUM JAMBOLANUM, URANIUM NITRICUMEnergique, Inc.0d475595-7afe-423f-9da8-720f1513f9562024-10-24WarningsExact identifier
unii: Q40Q9N063P
Dental PainACETICUM ACIDUM, CALENDULA OFFICINALIS, ZINGIBER OFFICINALE, BRYONIA (ALBA), COFFEA TOSTA, LEDUM PALUSTRE, PHOSPHORUS, PLANTAGO MAJOR, SPIGELIA ANTHELMIA, ARNICA MONTANA, CHAMOMILLA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, ACONITUM NAPELLUS, ANTIMONIUM CRUDUM, MEZEREUM, SEPIA, STAPHYSAGRIA, MAGNESIA PHOSPHORICADeseret Biologicals, Inc.3a117358-3c51-4870-9932-701ffe90e3f82024-10-23WarningsExact identifier
unii: Q40Q9N063P
OratoxFUCUS VESICULOSUS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, THYMUS (SUIS), THYROIDINUM (SUIS), CALCAREA MURIATICA, IODIUM, NATRUM FLUORATUM, NATRUM MURIATICUM, SELENIUM METALLICUM, VANADIUM METALLICUM, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, EUGENOL, FORMALINUM, LIDOCAINE, MERCURIUS SOLUBILIS, MOLYBDENUM METALLICUM, NICCOLUM METALLICUM, PALLADIUM METALLICUM, STANNUM METALLICUM, TITANIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.b78d8991-ffbe-4b11-b9b9-8fe432bed8aa2024-10-23WarningsExact identifier
unii: M4I0D6VV5M
MetoxALLIUM SATIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, ASCORBICUM ACIDUM, CYSTEINUM, L-METHIONINE, PHYTOLACCA DECANDRA, THYROIDINUM (SUIS), CARBOLICUM ACIDUM, FORMALINUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, BORON, ARSENICUM ALBUM, ALUMINUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, LANTHANUM METALLICUM, NIOBIUM METALLICUM, NIOBIUM,Deseret Biologicals, Inc.ddaedfad-c7d1-4aeb-a52e-dce5c1b45c922024-10-22WarningsExact identifier
unii: 339NCG44TV
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions6aa6bfcc-024b-4ee2-a586-6c4ca879cea42024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions69eea039-0098-4e2f-a832-152583b16f052024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb7137912-d119-4899-9c93-09c1c625f2902024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: Q40Q9N063P
LACTATED RINGERSSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDEBecton Dickinson and Companybb2ad9cd-5d9a-4337-be61-0842d738c79e2024-10-16Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Elliotts BSODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATELukare Medical, LLC08036dbd-55b3-47b9-9890-000f253544f32024-10-16Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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