NDC 81033-016-05 - 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
81033-016
Requested NDC
81033-016-05
Package NDCs from labels
81033-016-05, 81033-016-50
Manufacturer
Kesin Pharma Corporation
Effective date
2025-03-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PROMETHAZINE HYDROCHLORIDE - Kesin Pharma CorporationKesin Pharma Corporation2025-03-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-016-05PROMETHAZINE HYDROCHLORIDE5 mL in 1 CUP, UNIT-DOSESOLUTION55
81033-016-50PROMETHAZINE HYDROCHLORIDE50 in 1 CARTONSOLUTION505

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-016PROMETHAZINE HYDROCHLORIDE SOLUTION [KESIN PHARMA CORPORATION]5Current NDC, 2 package rows20250316_28793bd2-bd40-4571-e063-6394a90ae789.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-016-05ML - Milliliter81033-01667c1adab-b297-4f5f-b0f8-f569a23ecd0612024-12-10
81033-016-50ML - Milliliter81033-016d3d3f10b-a55c-43be-9d65-db491217cd3c12024-12-10

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 187 · 3,730 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
M-Natal PlusVITAMIN A, VITAMIN C, VITAMIN D, VITAMIN E, THIAMINE, RIBOFLAVIN, NIACIN, VITAMIN B6, FOLIC ACID, VITAMIN B12, CALCIUM, IRON, ZINC, COPPERREMEDYREPACK INC.5d67a268-437b-403d-9d05-6524c4a7c4992026-08-11WarningsExact identifier
unii: PQ6CK8PD0R
Aire-Master Foaming Hand Sanitizer Fragrance FreeALCOHOLWhisk Products, Inc.56a8f08e-7683-d155-e063-6394a90ac77b2026-08-11WarningsExact identifier
unii: 3K9958V90M
Ethyl alcoholETHYL ALCOHOLStrategic Sourcing Services LLC4fec6f1f-0249-423f-bd3c-427aa6924c6f2026-08-10Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing WipesALCOHOLMAGICARE TECH CORP3113dd38-257e-4b30-a611-1f259d1e3d1b2026-08-10WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer, Orchid Vanilla ScentedALCOHOLFourstar Group USA, Inc.cca1b0ff-f8bd-4440-939e-de3fb7920c2d2026-08-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Raspberry White Tea ScentedALCOHOLFourstar Group USA, Inc.c673389a-7154-440f-a1d4-60fe7bcf54f22026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
unii: 3K9958V90M
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
PNV PrenatolMULTIVITAMINPureTek Corporation583f0194-0306-f31b-e063-6394a90a2a102026-08-06Warnings, Adverse reactionsExact identifier
unii: PQ6CK8PD0R
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD585daf42-ec83-d222-e063-6294a90a83702026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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