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 2 of 187 · 3,730 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa72fe-7667-fb21-e063-6294a90a5e112026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizerALCOHOLChurch & Dwight Co., Inc.5aaa809e-71b8-7498-e063-6394a90a9ff82026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5aaa8d3c-e386-1527-e063-6294a90a07ac2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon GingerbreadALCOHOLChurch & Dwight Co., Inc.5aaa9d84-3f84-223e-e063-6294a90a79fb2026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5aaab1c9-c25c-344a-e063-6294a90a228d2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti CakeALCOHOLChurch & Dwight Co., Inc.5aaacef6-3b8b-ace4-e063-6394a90ab8592026-09-04WarningsExact identifier
unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla BlossomALCOHOLChurch & Dwight Co., Inc.5aaae919-4adc-c146-e063-6394a90a89042026-09-04WarningsExact identifier
unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5aaaf5a5-d43f-cf23-e063-6394a90a72ef2026-09-04WarningsExact identifier
unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5aaaff8f-5f6b-d575-e063-6394a90a1edc2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight SmoresALCOHOLChurch & Dwight Co., Inc.5aab0ca1-b3c4-964f-e063-6294a90a263f2026-09-04WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry FizzALCOHOLChurch & Dwight Co., Inc.5aab1faa-d884-1a55-e063-6394a90ad6e22026-09-04WarningsExact identifier
unii: 3K9958V90M
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed3796ee-3078-e850-e053-2a95a90a318a2026-09-03WarningsExact identifier
unii: 3K9958V90M
EquateETHYL ALCOHOLWal-Mart Stores Inc.ed63bd55-941f-9785-e053-2995a90a59522026-09-03WarningsExact identifier
unii: 3K9958V90M
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDERedpharm Drug5a797d11-19b0-fd33-e063-6394a90a4d582026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: R61ZEH7I1I
biom Sanitizing Alcohol Wipes - Eucalyptus ChillALCOHOLBiom Innovations Inc23a89b5b-ee5f-4480-e063-6394a90a03b42026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc5a8186f8-2f47-e57c-e063-6394a90a723a2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Aloe YouALCOHOLChurch & Dwight Co., Inc.5a83e963-6a61-fa59-e063-6394a90ade6c2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Berry BlissALCOHOLChurch & Dwight Co., Inc.5a83fc8f-31db-fd2a-e063-6294a90a8c432026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Blue SandalwoodALCOHOLChurch & Dwight Co., Inc.5a840981-765b-07f1-e063-6294a90ac6a32026-09-02WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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