FDA.reportPublic FDA data

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 9 of 187 · 3,730 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
unii: 3K9958V90M
Uline Hand SanitizerALCOHOLUlinea7aa3bde-d36e-f9d4-e053-2a95a90a6e6a2026-08-06WarningsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing Wipes LavenderALCOHOLMagicare Tech Corp9b66b3bd-1e08-485e-b961-b67a2fcc47512026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.ba91112c-5091-4972-84c9-5447eb0b504c2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHYL ALCOHOLApollo Health and Beauty Care5245e2a0-f871-ded0-e063-6394a90a86072026-08-05WarningsExact identifier
unii: 3K9958V90M
Vitamin E and AloeETHYL ALCOHOLApollo Health and Beauty Care52460290-a376-24b3-e063-6394a90a63482026-08-05WarningsExact identifier
unii: 3K9958V90M
Gingerbread Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation5014eea8-6ee3-5ed2-e063-6294a90adac42026-08-05WarningsExact identifier
unii: 3K9958V90M
Frosted Cherry Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation4ffcf42b-c650-7c76-e063-6394a90a059c2026-08-05WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
unii: 3K9958V90M
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Germs Be Gone Antiseptic Hand Sanitizer Clean and FreshALCOHOLRejoice Industries Canada Inc.1c11a785-d60c-4159-8e63-5ddcf88c23b02026-08-04WarningsExact identifier
unii: 3K9958V90M
MG DermaSpray 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.153ed8ff-5632-4f21-84de-2b87ac2bef312026-08-04WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD57086be5-b7a5-b61e-e063-6394a90abe792026-08-03WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Fresh Squeezed SpearmintALCOHOLShenzhen Lantern Scicence Co.,Ltd.581b4b8d-fe65-f297-e063-6394a90a5a432026-08-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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