FDA.reportPublic FDA data

NDC 66689-063-01 - Donnatal

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
66689-063
Requested NDC
66689-063-01
Package NDCs from labels
66689-063-01, 66689-063-10, 66689-063-40, 66689-063-50, 66689-063-99
Manufacturer
VistaPharm, LLC
Effective date
2022-07-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Donnatal - VistaPharm, LLCVistaPharm, LLC2022-07-07HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
66689-063-10DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only
66689-063-40DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only
66689-063-50DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only
66689-063-99DONNATAL® (Phenobarbital, Hyoscyamine Sulfate, Atropine Sulfate, Scopolamine Hydrobromide) Elixir Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66689-063-01Donnatal5 mL in 1 CUP, UNIT-DOSEELIXIR58
66689-063-10Donnatal10 in 1 TRAYELIXIR108
66689-063-10Donnatal1 in 1 CASEELIXIR18
66689-063-40Donnatal10 in 1 TRAYELIXIR108
66689-063-40Donnatal4 in 1 CASEELIXIR48
66689-063-50Donnatal10 in 1 TRAYELIXIR108
66689-063-50Donnatal5 in 1 CASEELIXIR58
66689-063-99Donnatal10 in 1 CASEELIXIR108
66689-063-99Donnatal10 in 1 TRAYELIXIR108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-063DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [VISTAPHARM, LLC]8Current NDC, Legacy NDC, 9 package rows20240209_11a48ba9-576b-4e8c-9536-6e83636d6930.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-063-01ML - Milliliter66689-063a87658df-179e-46ed-b53b-b3d9face4c0212017-11-06
66689-063-10ML - Milliliter66689-0638bd68182-d1c4-43c0-a18b-198600c498fc12017-11-06

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 177 · 3,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhenobarbitalPHENOBARBITALREMEDYREPACK INC.6c7189e8-949e-4ecd-bfdf-5347d4f1a3872026-08-05Warnings, Adverse reactionsExact identifier
unii: YQE403BP4D
PhenobarbitalPHENOBARBITALREMEDYREPACK INC.9efb749b-085d-4a19-9342-e26c635800a82026-08-05Warnings, Adverse reactionsExact identifier
unii: YQE403BP4D
PhenobarbitalPHENOBARBITALREMEDYREPACK INC.3e7637d9-2a8a-4063-8b14-1d1444629a152026-08-05Warnings, Adverse reactionsExact identifier
unii: YQE403BP4D
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
PhenobarbitalPHENOBARBITALREMEDYREPACK INC.b43c3611-24f6-4eaf-ac68-c2807f92ca982026-08-04Warnings, Adverse reactionsExact identifier
unii: YQE403BP4D
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
AtropineATROPINE SULFATEGland Pharma Limiteda116af5c-ba4c-408c-9a02-4bc33772aa8d2026-08-03Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
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
Mistify Hand Sanitizer Cotton Candy and Gummy BearALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987e492-b3b6-ed57-e063-6394a90a223a2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Soft Serve And Cherry CrushALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987ed0c-2560-f787-e063-6394a90af7bd2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Coconut And Whipped CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5988393d-1554-5588-e063-6394a90a470f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Green Apple And WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598ec764-bad1-d14b-e063-6394a90a23052026-08-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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