FDA.reportPublic FDA data

Donnatal

Product NDC
59212-422
11-digit product format
592120422
Labeler code
59212
Product ID
59212-422_f15ad820-c07e-4e6b-a154-7ddca20bc838
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine hydrobromide
Dosage form
ELIXIR
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/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 Identifiers#

Field, Values table
FieldValues
UniiYQE403BP4D, 451IFR0GXB, 03J5ZE7KA5, F2R8V82B84
Rxcui1046787, 1046924

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
59212-422-04Donnatal118 mL in 1 BOTTLEELIXIR11813
59212-422-10Donnatal10 mL in 1 BOTTLEELIXIR1013
59212-422-16Donnatal473 mL in 1 BOTTLEELIXIR47313

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59212-422-04ML - Milliliter59212-422f73b946d-dab7-455d-8ac9-d649acd7502112015-03-03
59212-422-16ML - Milliliter59212-422b1c972eb-21d4-48a9-8a34-50b4cf1105b112015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine sulfateACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
Hyoscyamine sulfateACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
PhenobarbitalACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
Scopolamine hydrobromideACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
AtropineACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
HyoscyamineACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
PhenobarbitalACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
ScopolamineACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
alcoholINACTIVE INGREDIENT3K9958V90MDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
sorbitolINACTIVE INGREDIENT506T60A25RDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
sucroseINACTIVE INGREDIENTC151H8M554DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4
waterINACTIVE INGREDIENT059QF0KO0RDONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [CONCORDIA PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59212-422DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE) ELIXIR [ADVANZ PHARMA (US) CORP.]13Current NDC, Legacy NDC, 3 package rows20241220_4dba30db-7979-455f-a225-24f0a04d744e.zip

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 SolutionPSN4dba30db-7979-455f-a225-24f0a04d744e13
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSN4dba30db-7979-455f-a225-24f0a04d744e13
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]SBD4dba30db-7979-455f-a225-24f0a04d744e13
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD4dba30db-7979-455f-a225-24f0a04d744e13
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY4dba30db-7979-455f-a225-24f0a04d744e13
1046924Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral SolutionSY4dba30db-7979-455f-a225-24f0a04d744e13
1046924Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral SolutionSY4dba30db-7979-455f-a225-24f0a04d744e13
1046924Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral SolutionSY4dba30db-7979-455f-a225-24f0a04d744e13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59212-422-0459212042204118 mL in 1 BOTTLE (59212-422-04) 118 ml1980-12-300000-00-00NoNoCurrent
59212-422-105921204221010 mL in 1 BOTTLE (59212-422-10) 10 ml1980-12-300000-00-00NoNoCurrent
59212-422-1659212042216473 mL in 1 BOTTLE (59212-422-16) 473 ml1980-12-300000-00-00NoNoCurrent