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 7 of 177 · 3,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited424454c9-c1d3-46ec-b186-9159c29f7a4a2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Alcohol SanitizerETHANOLZep Inc.b932a59c-a739-5441-e053-2a95a90a4cfa2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Fuzion Instant Hand SanitizerALCOHOLZep Inc.b43c5701-22ee-1de4-e053-2995a90a8f642026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ee8023-0128-56d6-e053-2a95a90ab4ed2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Instant Hand Sanitizer GelALCOHOLZep Inc.b0ed98cd-871b-d862-e053-2995a90a14cc2026-08-13WarningsExact identifier
unii: 3K9958V90M
AFCO 5511 Sanifect E3ETHANOLZep Inc.34795eba-9ec4-6401-e063-6394a90af4282026-08-13WarningsExact identifier
unii: 3K9958V90M
Alcohol Hand SanitizerETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fa90dc-c3b5-787b-e063-6294a90a2e172026-08-13WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST COCONUT VANILLA SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited89dd227a-365f-4d8b-b21a-4f1c1b5c9c0a2026-08-13WarningsExact identifier
unii: 3K9958V90M
SprinJeneALCOHOLHealth and Natural Beauty USA Corp1853f023-f4db-4cd8-a4df-a439bc306cc32026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST WATERMELON POP SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited3fea32bb-98ec-4dc6-97d3-c77d8e476c042026-08-13WarningsExact identifier
unii: 3K9958V90M
WhiskCare 373ALCOHOLWhisk Products, Inc.57d5cd5d-8597-ce66-e063-6394a90a00472026-08-12WarningsExact identifier
unii: 3K9958V90M
ZoviroALCOHOLZoviro, LLC9c8ca084-8aef-4616-8d51-aaff3eb253432026-08-12WarningsExact identifier
unii: 3K9958V90M
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
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
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

Reported adverse events (FAERS/openFDA)#

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