FDA.reportPublic FDA data

Donnatal

Product NDC
66689-063
Requested package NDC
66689-063-99
11-digit product format
666890063
Labeler code
66689
Product ID
66689-063_b528eb39-f078-452f-939c-2daebd4d70ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage form
ELIXIR
Route
ORAL
Labeler
VistaPharm, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-10-26
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Anticholinergic [EPC], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Donnatal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL.0194 mg/5mL
HYOSCYAMINE SULFATE.1037 mg/5mL
ATROPINE SULFATE16.2 mg/5mL
SCOPOLAMINE HYDROBROMIDE.0065 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
YQE403BP4DInternal UNII lookup
F2R8V82B84Internal UNII lookup
03J5ZE7KA5Internal UNII lookup
451IFR0GXBInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1046787Internal RxNorm lookup
1046924Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
11a48ba9-576b-4e8c-9536-6e83636d6930Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
fe8ea78e-e1a4-44bf-a6b2-42eed76976bbProduct name520250218
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
e3e67a66-d325-4d80-8f9d-059e736d7b00Product name120230912
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

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 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

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DonnatalPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDEVistaPharm, LLC11a48ba9-576b-4e8c-9536-6e83636d69302022-07-07Warnings, Adverse reactionsExact identifier
ndc (package): 66689-063-99
ndc (product): 66689-063
ndc11 (package): 66689006399

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046924Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral SolutionPSN11a48ba9-576b-4e8c-9536-6e83636d69308
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSN11a48ba9-576b-4e8c-9536-6e83636d69308
1046924atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution [Donnatal]SBD11a48ba9-576b-4e8c-9536-6e83636d69308
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD11a48ba9-576b-4e8c-9536-6e83636d69308
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY11a48ba9-576b-4e8c-9536-6e83636d69308
1046924Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral SolutionSY11a48ba9-576b-4e8c-9536-6e83636d69308
1046924Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral SolutionSY11a48ba9-576b-4e8c-9536-6e83636d69308
1046924Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral SolutionSY11a48ba9-576b-4e8c-9536-6e83636d69308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-063-996668900639910 TRAY in 1 CASE (66689-063-99) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-063-01) 10 tray2017-10-260000-00-00NoNoCurrent