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
2026-10-12
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.2026-10-12HUMAN 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 8 of 28 · 554 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDECranbury Pharmaceuticals, LLCa8b57027-a4b8-4149-93e8-aa3e7a6d6dc32025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDECranbury Pharmaceuticals, LLCd32ea9db-11d4-400d-b7ef-dd0ec01b796d2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProPharma Distribution45b09a50-dab2-e83d-e063-6394a90aa8132025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 992460
unii: R61ZEH7I1I
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP69934bbb-922c-4752-b253-f2f07340de8d2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions46b869e2-9305-43ae-bb15-919a6d09b6ff2025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
unii: 339NCG44TV
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
unii: 339NCG44TV
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3 (CHOLECALCIFEROL) , CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIA CARBONICANutritional Specialties, Inc.4c86b348-5808-4d6d-b283-00ab37557fd72025-11-25WarningsExact identifier
unii: M4I0D6VV5M
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEChartwell Governmental & Specialty RX, LLC.e5d2156d-1f66-4fdf-a3ae-5e1325218c8b2025-11-21Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAmerican Health Packaginga8fe4bc5-961b-4441-b8e2-ef93e4e137b62025-11-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I

Reported adverse events (FAERS/openFDA)#

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