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 3 of 177 · 3,532 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Touchland Power Mist Hand Sanitizer Citrus GroveALCOHOLChurch & Dwight Co., Inc.5a84344b-4ddb-32e5-e063-6394a90a628b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Frosted MintALCOHOLChurch & Dwight Co., Inc.5a8445e6-42cc-3e55-e063-6394a90ac0e12026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Lemon Lime SpritzALCOHOLChurch & Dwight Co., Inc.5a84870b-e539-9dd8-e063-6294a90aaf0b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Pure LavenderALCOHOLChurch & Dwight Co., Inc.5a848ff6-fbdd-a76c-e063-6294a90a324b2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer RainwaterALCOHOLChurch & Dwight Co., Inc.5a84969c-aa38-aeb7-e063-6294a90a69422026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer UnscentedALCOHOLChurch & Dwight Co., Inc.5a84d2e3-d839-f7c6-e063-6294a90aa32f2026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Beach CocoALCOHOLChurch & Dwight Co., Inc.5a84db79-1bab-fff8-e063-6294a90aab372026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Velvet PeachALCOHOLChurch & Dwight Co., Inc.5a84ed55-f41d-d05f-e063-6394a90ad0122026-09-02WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer AppleliciousALCOHOLChurch & Dwight Co., Inc.5a84fbeb-dd64-26ce-e063-6294a90aa8562026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS Pretty Petal Scented HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3884e292-1f03-4e08-90d9-82b601c0c5c22026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care VANILLA FIG HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.c5490afe-b2b4-4c6c-910f-af828362d6a42026-09-02WarningsExact identifier
unii: 3K9958V90M
Smart Care MISTLETOE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.fca4510f-f130-464c-ade4-fe05bdae3e7b2026-09-01WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer,2pk -Gingerbread and Cherry CobblerALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a52731b-5e8c-5ae6-e063-6394a90a8b042026-08-31WarningsExact identifier
unii: 3K9958V90M
Atropine SulfateATROPINE SULFATEREMEDYREPACK INC.532aa441-92ec-42d6-862a-639f8cfe99512026-08-31Warnings, Adverse reactionsExact identifier
unii: 03J5ZE7KA5
PhenobarbitalPHENOBARBITALREMEDYREPACK INC.4e6f2a3b-c6e2-488e-827a-e8646279532d2026-08-31Warnings, Adverse reactionsExact identifier
unii: YQE403BP4D
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f875e065-7b3e-45dc-8a33-b893ab8306952026-08-31WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.30e11bf0-1a21-45b1-adf9-cf3845419a982026-08-31WarningsExact identifier
unii: 3K9958V90M
Swisher Instant Hand Sanitizer GelALCOHOLEcolab Inc.1f84e842-ece4-4eb7-9ccf-d86cec78dbf22026-08-31WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer(Oval Shape)with Beaded Wristlet - Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a4fb4b6-ba9e-5b82-e063-6294a90a47342026-08-30WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer with Woven Lanyard and Chainendants- WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.5a503581-061b-0050-e063-6294a90af48a2026-08-30WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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