Donnatal

Product NDC
17856-0423
11-digit product format
178560423
Labeler code
17856
Product ID
17856-0423_42d4c5a0-3af9-481f-b29e-813b66090ba1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENOBARBITAL
Dosage form
ELIXIR
Route
ORAL
Labeler
Atlantic Biologicals Corps
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2009-11-01
Marketing end
0000-00-00
Substance
PHENOBARBITAL; HYOSCYAMINE SULFATE; SCOPOLAMINE HYDROBROMIDE; ATROPINE SULFATE
Active strength
16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
Pharmacologic classes
Anticholinergic [EPC],Cholinergic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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 · 15 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct17856-0423DDiscontinued by firm2026-10-12
excluded productproduct17856-0423IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-2DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-3DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-4DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-5DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-8DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-9DDiscontinued by firm2026-10-12
excluded packagepackage17856-042317856-0423-2IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-3IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-4IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-5IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-6IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-8IInactivated by FDA2026-10-12
excluded packagepackage17856-042317856-0423-9IInactivated by FDA2026-10-12

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 5 · 252 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-3IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-4IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-9DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-2IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-8IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-8DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-9IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-5DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-5IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-4DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage17856-0423-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-3IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-4IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-9DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-2IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-8IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-8DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-9IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-5DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-5IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-4DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0423-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-3IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-4IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-9DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-2IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-8IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-8DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-9IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-5DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-5IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-4DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0423-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-3IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-4IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-9DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-2IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-8IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-8DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-9IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-5DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-5IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-4DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0423-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…

Reported adverse events (FAERS/openFDA)#

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

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0423-2Donnatal15 mL in 1 CUPELIXIR1516
17856-0423-3Donnatal10 mL in 1 CUPELIXIR1016
17856-0423-4Donnatal5 mL in 1 CUPELIXIR516
17856-0423-5Donnatal5 mL in 1 CUPELIXIR516
17856-0423-6Donnatal5 mL in 1 CUPELIXIR516
17856-0423-6Donnatal10 in 1 CASEELIXIR1016
17856-0423-8Donnatal15 mL in 1 CUPELIXIR1516
17856-0423-9Donnatal10 mL in 1 CUPELIXIR1016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0423-3ML - Milliliter17856-0423d6bdfe1b-0918-4a47-bb1c-85bffd7caf9612013-05-02
17856-0423-5ML - Milliliter17856-0423966e1aa6-040f-42f7-b4fb-dc59baa778e212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Atropine sulfateACTIVE INGREDIENT03J5ZE7KA5DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
Hyoscyamine sulfateACTIVE INGREDIENTF2R8V82B84DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
PhenobarbitalACTIVE INGREDIENTYQE403BP4DDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
Scopolamine hydrobromideACTIVE INGREDIENT451IFR0GXBDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
AtropineACTIVE MOIETY7C0697DR9IDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
HyoscyamineACTIVE MOIETYPX44XO846XDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
PhenobarbitalACTIVE MOIETYYQE403BP4DDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
ScopolamineACTIVE MOIETYDL48G20X8XDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
ALCOHOLINACTIVE INGREDIENT3K9958V90MDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
GRAPEINACTIVE INGREDIENT6X543N684KDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
SORBITOLINACTIVE INGREDIENT506T60A25RDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
SUCROSEINACTIVE INGREDIENTC151H8M554DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12
WATERINACTIVE INGREDIENT059QF0KO0RDONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [ATLANTIC BIOLOGICALS CORPS]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0423DONNATAL (PHENOBARBITAL) ELIXIR [ATLANTIC BIOLOGICALS CORPS]16Legacy NDC, 8 package rows20180510_5d69ffc1-4608-4d73-ae91-838983bcf98d.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 SolutionPSN5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046787PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral SolutionPSN5d69ffc1-4608-4d73-ae91-838983bcf98d16
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]SBD5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046787atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral SolutionSCD5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046787atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral SolutionSY5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046924Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral SolutionSY5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046924Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral SolutionSY5d69ffc1-4608-4d73-ae91-838983bcf98d16
1046924Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral SolutionSY5d69ffc1-4608-4d73-ae91-838983bcf98d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
17856-0423-21785604230215 mL in 1 CUP15 mlHistorical
17856-0423-31785604230310 mL in 1 CUP10 mlHistorical
17856-0423-4178560423045 mL in 1 CUP5 mlHistorical
17856-0423-5178560423055 mL in 1 CUP5 mlHistorical
17856-0423-6178560423065 mL in 1 CUP5 mlHistorical
17856-0423-81785604230815 mL in 1 CUP15 mlHistorical
17856-0423-91785604230910 mL in 1 CUP10 mlHistorical