FDA.reportPublic FDA data

NDC 0641-6085-01 - PHENERGAN

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
0641-6085
Requested NDC
0641-6085-01
Package NDCs from labels
0641-6085-01, 0641-6085-25
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2024-05-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PHENERGAN Injection (promethazine hydrochloride Injection, USP) Rx onlyHikma Pharmaceuticals USA Inc.2024-05-20HUMAN 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
0641-6085-01PHENERGAN1 mL in 1 VIALINJECTION18
0641-6085-25PHENERGAN25 in 1 CARTONINJECTION258

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6085PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20240606_481866da-a712-48a5-853f-8e84aacaab6d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6085-01ML - Milliliter0641-608550f91db9-692b-4dde-87f3-182e33936af512012-07-24
0641-6085-25ML - Milliliter0641-6085d4418999-3934-4bbd-9fce-9999eb58033b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
PROMETHAZINEACTIVE MOIETYFF28EJQ494PHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
PHENOLINACTIVE INGREDIENT339NCG44TVPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4
WATERINACTIVE INGREDIENT059QF0KO0RPHENERGAN (PROMETHAZINE HYDROCHLORIDE) INJECTION [WEST-WARD PHARMACEUTICAL CORP.]4

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 · 560 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATECranbury Pharmaceuticals, LLC785c605e-1907-4fac-8b69-d504a2076f8e2025-12-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
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

Reported adverse events (FAERS/openFDA)#

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