FDA.reportPublic FDA data

Donnatal

Product NDC
59212-425
11-digit product format
592120425
Labeler code
59212
Product ID
59212-425_0395fab5-b3e6-4822-872c-16002ae8ff58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Advanz Pharma (US) Corp.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1980-12-30
Substance
ATROPINE SULFATE; HYOSCYAMINE SULFATE; PHENOBARBITAL; SCOPOLAMINE HYDROBROMIDE
Active strength
.0194; .1037; 16.2; .0065 mg/1; mg/1; mg/1; mg/1
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59212-42559212-425-11DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENOBARBITAL.0194 mg/1
HYOSCYAMINE SULFATE.1037 mg/1
ATROPINE SULFATE16.2 mg/1
SCOPOLAMINE HYDROBROMIDE.0065 mg/1

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
1046815Internal RxNorm lookup
1046978Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c93cccdc-2f92-4cb3-9d14-06acdd51d94cAvailable 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
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59212-425-04Donnatal04 in 1 BOTTLE, PLASTICTABLET0414
59212-425-10Donnatal100 in 1 BOTTLE, PLASTICTABLET10014
59212-425-11Donnatal1000 in 1 BOTTLE, PLASTICTABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-425-10EA - Each59212-4253a55d886-12c4-4343-81ac-4fcfa89105f112015-03-03
59212-425-11EA - Each59212-4252d176477-460f-4a1c-88dc-8f3f7538223112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
ATROPINE SULFATEACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
HYOSCYAMINE SULFATEACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
PhenobarbitalACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
PHENOBARBITALACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
SCOPOLAMINE HYDROBROMIDEACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
ATROPINEACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
ATROPINEACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
HYOSCYAMINEACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
HYOSCYAMINEACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
PHENOBARBITALACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
PhenobarbitalACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
SCOPOLAMINEACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
SCOPOLAMINEACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [AVKARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3
SUCROSEINACTIVE INGREDIENTC151H8M554DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [CONCORDIA PHARMACEUTICALS INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-425DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) TABLET [ADVANZ PHARMA (US) CORP.]14Current NDC, Legacy NDC, 3 package rows20241224_c93cccdc-2f92-4cb3-9d14-06acdd51d94c.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 HYDROBROMIDEAdvanz Pharma (US) Corp.c93cccdc-2f92-4cb3-9d14-06acdd51d94c2024-12-05Warnings, Adverse reactionsExact identifier
ndc (product): 59212-425

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / PHENobarbital 16.2 MG / scopolamine HBr 0.0065 MG Oral TabletPSNc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978Donnatal 0.0194 MG / 0.1037 MG / 16.2 MG / 0.0065 MG Oral TabletPSNc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral Tablet [Donnatal]SBDc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046815atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG Oral TabletSCDc93cccdc-2f92-4cb3-9d14-06acdd51d94c14
1046978Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) Oral TabletSYc93cccdc-2f92-4cb3-9d14-06acdd51d94c14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-425-04592120425044 TABLET in 1 BOTTLE, PLASTIC (59212-425-04) 4 tablet1980-12-300000-00-00NoNoCurrent
59212-425-1059212042510100 TABLET in 1 BOTTLE, PLASTIC (59212-425-10) 100 tablet1980-12-300000-00-00NoNoCurrent
59212-425-11592120425111000 in 1 BOTTLE, PLASTICHistorical