FDA.reportPublic FDA data

NDC 0641-1496-31 - 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
0641-1496
Requested NDC
0641-1496-31
Package NDCs from labels
0641-1496-31, 0641-1496-35
Manufacturer
Henry Schein, Inc.
Effective date
2025-11-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Promethazine HCL 50 mg/mL Injection, USP 1 mL Single Dose AmpuleHenry Schein, Inc.2025-11-07HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride Injection, USPHikma Pharmaceuticals USA Inc. | HIKMA FARMACEUTICA (PORTUGAL), S.A2025-06-30HUMAN PRESCRIPTION DRUG LABEL
PROMETHAZINE HCI - HF Acquisition Co. LLC, DBA HealthFirstHF Acquisition Co. LLC, DBA HealthFirst2024-02-22HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-29HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1496-31Promethazine Hydrochloride1 mL in 1 AMPULEINJECTION15
0641-1496-35Promethazine Hydrochloride25 in 1 PACKAGEINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1496PROMETHAZINE HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20240412_13d9e59d-eadb-41d5-9f47-9c11a6efb31c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-1496-31ML - Milliliter0641-1496c081beed-7064-44b2-ae3e-5b034453696812012-07-24
0641-1496-35ML - Milliliter0641-1496356a6fa1-501c-4099-b031-6f5581d18a2212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Promethazine HydrochlorideACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]5
PromethazineACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]5
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL 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 7 of 29 · 561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Bio Biological DetoxECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PROPOLIS, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, THYMUS SERPYLLUM, GLANDULA SUPRARENALIS SUIS, LYMPH NODE (SUIS), SPLEEN (SUIS), THYROIDINUM (SUIS), BELLADONNA, HYPERICUM PERFORATUM, PHOSPHORUS, PYROGENIUM, ANTHRACINUM, ARSENICUM, CARBOLICUM ACIDUM, HEPAR SULPHURIS CALCAREUM, LACHESIS, VARIOLINUM, BOTULINUM, DYSENTERY BACILLUS, GAERTNER BACILLUS, FRANCISELLA TULARENSIS, COXIELLA BURNETII, LAC CANINUM, MALARIA OFFICINALIS,BioActive Nutritional, Inc.9a6671bb-b070-4f97-bdc0-189cf60407ee2025-12-30WarningsExact identifier
unii: 339NCG44TV
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
Absorbine Jr. Pro RollonABSORBINE JR. PRO ROLLONClarion Brands, LLC470efcd0-d350-3dc4-e063-6394a90ab8c12025-12-28WarningsExact identifier
unii: 339NCG44TV
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENorthwind Health Company, LLCba4ec2d8-1da4-473b-9ef8-57051cb2c0f72025-12-26Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
ABSORBINE jr.LIDOCAINE HCL, PHENOLClarion Brands, LLCe1de73bb-917c-48d1-9a78-00c76edddb982025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro CreamLIDOCAINE HCL, PHENOLClarion Brands, LLC17b3f1e6-5554-4f3e-b133-76ae8ffea9192025-12-23WarningsExact identifier
unii: 339NCG44TV
Absorbine Jr Pro No Mess Roll-on PlusLIDOCAINE HCL, PHENOLClarion Brands, LLCa7172f17-1525-4738-b72c-92479c730af22025-12-23WarningsExact identifier
unii: 339NCG44TV
calcium chlorideCALCIUM CHLORIDEAmneal Pharmaceuticals LLC7649c84f-f1c2-4169-962d-ccbac56523a92025-12-22Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLC0b5734b8-6a52-44ff-ac29-9a91a43353942025-12-20Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProPharma Distribution38673af1-112e-9ddd-e063-6294a90af4652025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA083312
rxcui: 992460
unii: R61ZEH7I1I
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: Q40Q9N063P
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECosette Pharmaceuticals, Inc.3b02cda4-9b24-79c9-e063-6294a90af5b92025-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Epl-Cell RepairCELL REPAIR AIDVitality Works, Inc.134d1cc1-2300-409d-b562-98ce807e77b32025-12-17WarningsExact identifier
unii: M4I0D6VV5M
HivesECHINACEA ANG, APIS MEL, ARSENICUM ALB, CARBOLICUM AC, LEDUM, RHUS TOX, SULPHUR, URTICA URENSNatural Creations, Incc453ac40-1865-4297-b7d4-c8e637bb5f942025-12-16WarningsExact identifier
unii: 339NCG44TV
Sore ThroatPHENOLEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)9128d59c-6fa9-4358-865a-802257a9bd252025-12-16WarningsExact identifier
unii: 339NCG44TV

Reported adverse events (FAERS/openFDA)#

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