FDA.reportPublic FDA data

NDC 0641-1495-31 - 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
0641-1495
Requested NDC
0641-1495-31
Package NDCs from labels
0641-1495-31, 0641-1495-35
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 25 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 Hydrochloride Injection, USPREMEDYREPACK INC.2023-10-03HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - Medical Purchasing Solutions, LLCMedical Purchasing Solutions, LLC2023-05-02HUMAN PRESCRIPTION DRUG LABEL
Promethazine Hydrochloride - General Injectables & Vaccines, IncGeneral Injectables & Vaccines, Inc2022-12-29HUMAN PRESCRIPTION DRUG LABEL
Model AA-8565CV-ACT Model AA-8565CV - Aerospace Accessory Service, IncAerospace Accessory Service, Inc2021-05-18MEDICAL DEVICE
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit
Promethazine Hydrochloride Injection, USP Rx onlyDispensing Solutions Inc.2010-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-1495-31Promethazine Hydrochloride1 mL in 1 AMPULEINJECTION15
0641-1495-35Promethazine Hydrochloride25 in 1 CARTONINJECTION255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-1495PROMETHAZINE 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
0641-1495-31ML - Milliliter0641-14958f71d813-efd2-4f08-b2fa-1b5da840c09112012-07-24
0641-1495-35ML - Milliliter0641-14954630f281-0707-4994-872a-ee7bd8a6722d12012-07-24

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, SOLUTION [DISPENSING SOLUTIONS INC.]1
PROMETHAZINE HYDROCHLORIDEACTIVE INGREDIENTR61ZEH7I1IPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
PROMETHAZINEACTIVE MOIETYFF28EJQ494PROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
ACETIC ACIDINACTIVE INGREDIENTQ40Q9N063PPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
PHENOLINACTIVE INGREDIENT339NCG44TVPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9BPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]1
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROMETHAZINE HYDROCHLORIDE INJECTION [WEST-WARD PHARMACEUTICAL CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RPROMETHAZINE HYDROCHLORIDE INJECTION, SOLUTION [DISPENSING SOLUTIONS INC.]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 3 of 733 · 14,658 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VICKS ZzzQuil NIGHTTIME SLEEP-AID Diphenhydramine HCl FREE OFDIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company01906eed-78ee-f2a1-e063-6294a90a809b2026-09-08WarningsExact identifier
unii: TC2D6JAD40
Overnight Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, TRIPROLIDINE HCLRARITAN PHARMACEUTICALSeef00453-9f4f-4a05-bb4e-49b94705b52c2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain and Fever ChildrensACETAMINOPHENDOLGENCORP, LLCc637b39c-a049-43af-a582-fc242e940d852026-09-08WarningsExact identifier
unii: 362O9ITL9D
Nighttime Severe Cold and CoughACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINERARITAN PHARMACEUTICALS INC9819155b-2713-42be-867e-16605e7643d02026-09-08WarningsExact identifier
unii: TC2D6JAD40
unii: 362O9ITL9D
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare07b4e0ed-2b00-4d0a-ad8f-fc6deff153252026-09-08WarningsExact identifier
unii: 451W47IQ8X
Pain Reliever Extra StrengthACETAMINOPHENWalgreen Companyf7667529-09c0-4603-8080-f236144fac362026-09-08WarningsExact identifier
unii: 362O9ITL9D
UP AND UP CHILDRENS ACETAMINOPHENACETAMINOPHENTarget Corporatione2989ead-7fdc-4295-bf94-4231957756702026-09-08WarningsExact identifier
unii: 362O9ITL9D
Cold and Flu HBPACETAMINOPHEN, CHLORPHENIRAMINE MALEATEWALMART INC.f9d1dfd1-527f-491d-9188-14886ac70ced2026-09-08WarningsExact identifier
unii: 362O9ITL9D
Pain Relief Extra StrengthACETAMINOPHENRite Aid Corporationd846065a-5c39-4f4b-894c-4280acaaf4fa2026-09-08WarningsExact identifier
unii: 362O9ITL9D
DRx Choice Sore Throat Menthol FlavorPHENOLRARITAN PHARMACEUTICALS INCe3269b12-5c05-45a6-81f2-65d9f016c3aa2026-09-08WarningsExact identifier
unii: 339NCG44TV
severe cold and cough daytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDERARITAN PHARMACEUTICALS INC3ce8508e-7d9d-4413-858a-8f952e760c012026-09-08WarningsExact identifier
unii: 362O9ITL9D
Multi Symptom Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLRARITAN PHARMACEUTICALS INCd9606c9a-31b1-4121-9870-809a05f5b68a2026-09-08WarningsExact identifier
unii: 362O9ITL9D
PollutoxACETONE, ARSENICUM ALBUM, BENZINUM, BERBERIS VULGARIS, CADMIUM SULPHURATUM, CARBON DIOXIDE, CARBONEUM SULPHURATUM, CHLORINUM, HYDROFLUORICUM ACIDUM, MELATONIN, MERCURIUS SOLUBILIS, NITROGENUM OXYGENATUM, NUX VOMICA, OZONE, PETROLEUM, PLUMBUM METALLICUM, STANNUM METALLICUM, SULPHURICUM ACIDUM, TOLUENE, URANIUM NITRICUMDeseret Biologicals, Inc.741fdddf-75af-45a2-9875-ee3b08b0decf2026-09-08WarningsExact identifier
unii: O40UQP6WCF
BZK Antiseptic ToweletteBENZALKONIUM CHLORIDE CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cd664e-f232-bd50-e063-6394a90ac1392026-09-07WarningsExact identifier
rxcui: 1038558
unii: F5UM2KM3W7
Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57ccc28b-5f5f-30ec-e063-6294a90a081c2026-09-07WarningsExact identifier
application number: M003
unii: ND2M416302
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
application number: M003
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
application number: M003
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
application number: M003
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
application number: M003
unii: 3K9958V90M
ALCOHOL PREP PADS MEDIUM STERILEISOPROPYL ALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO., LTD57cbbe72-24ec-2e4a-e063-6394a90abbd22026-09-07WarningsExact identifier
rxcui: 797544
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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