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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 17856-0423 | D | Discontinued by firm | 2026-10-12 | ||
| excluded product | product | 17856-0423 | I | Inactivated by FDA | 2026-10-12 | ||
| excluded package | package | 17856-0423 | 17856-0423-2 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-3 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-4 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-5 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-8 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-9 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-2 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-3 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-4 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-5 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-6 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-8 | I | Inactivated by FDA | 2026-10-12 | |
| excluded package | package | 17856-0423 | 17856-0423-9 | I | Inactivated by FDA | 2026-10-12 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-3 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-4 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-9 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-2 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-8 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-8 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-9 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-5 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-5 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-2 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-3 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-4 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-0423-6 | I | Inactivated by FDA | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-3 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-4 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-9 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-2 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-8 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-8 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-9 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-5 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-5 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-2 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-3 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-4 | D | Discontinued by firm | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-0423-6 | I | Inactivated by FDA | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-3 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-4 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-9 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-2 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-8 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-8 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-9 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-5 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-5 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-2 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-3 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-4 | D | Discontinued by firm | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-0423-6 | I | Inactivated by FDA | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-3 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-4 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-9 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-2 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-8 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-8 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-9 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-5 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-5 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-2 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-3 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-4 | D | Discontinued by firm | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-0423-6 | I | Inactivated by FDA | a1b67e2a42f9… | c4cf2c586c0d… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6c78bd43-efb4-4aeb-b7d8-eff1532f7822 | Product name | 4 | 20250801 |
| 41231c1e-8789-4da7-ac52-77fa90a85bf5 | Product name | 2 | 20250304 |
| fe8ea78e-e1a4-44bf-a6b2-42eed76976bb | Product name | 5 | 20250218 |
| e77ab9a2-80cf-4832-bff0-469bbc7cbcd0 | Product name | 2 | 20250214 |
| 5f84b7a7-523a-f042-dffb-1dadcd9b2407 | Product name | 4 | 20240110 |
| e3e67a66-d325-4d80-8f9d-059e736d7b00 | Product name | 1 | 20230912 |
| 0cbc6fb2-78c0-4b88-98f0-a4cc76ff95ca | Product name | 1 | 20230719 |
| 04cd5dc0-102f-46cb-8dbc-ca38dd2628d0 | Product name | 3 | 20230317 |
| dfd25202-b8d2-4628-9213-f3e0f9eafce5 | Product name | 4 | 20210513 |
| 4199bf9b-4718-828a-6dd6-ac2fbbd61687 | Product name | 1 | 20140508 |
| 4edd8af5-cea7-ae42-8023-e91c5335db1d | Product name | 1 | 20140508 |
| d3908afb-7784-440f-c406-88294732d36a | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0423-2 | Donnatal | 15 mL in 1 CUP | ELIXIR | 15 | 16 | |
| 17856-0423-3 | Donnatal | 10 mL in 1 CUP | ELIXIR | 10 | 16 | |
| 17856-0423-4 | Donnatal | 5 mL in 1 CUP | ELIXIR | 5 | 16 | |
| 17856-0423-5 | Donnatal | 5 mL in 1 CUP | ELIXIR | 5 | 16 | |
| 17856-0423-6 | Donnatal | 5 mL in 1 CUP | ELIXIR | 5 | 16 | |
| 17856-0423-6 | Donnatal | 10 in 1 CASE | ELIXIR | 10 | 16 | |
| 17856-0423-8 | Donnatal | 15 mL in 1 CUP | ELIXIR | 15 | 16 | |
| 17856-0423-9 | Donnatal | 10 mL in 1 CUP | ELIXIR | 10 | 16 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 17856-0423-3 | ML - Milliliter | 17856-0423 | d6bdfe1b-0918-4a47-bb1c-85bffd7caf96 | 1 | 2013-05-02 |
| 17856-0423-5 | ML - Milliliter | 17856-0423 | 966e1aa6-040f-42f7-b4fb-dc59baa778e2 | 1 | 2013-02-13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0423 | DONNATAL (PHENOBARBITAL) ELIXIR [ATLANTIC BIOLOGICALS CORPS] | 16 | Legacy NDC, 8 package rows | 20180510_5d69ffc1-4608-4d73-ae91-838983bcf98d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1046924 | Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution | PSN | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046787 | PHENobarbital 16.2 MG / hyoscyamine sulfate 0.1037 MG / atropine sulfate 0.0194 MG / scopolamine HBr 0.0065 MG in 5 mL Oral Solution | PSN | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046924 | atropine 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] | SBD | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046787 | atropine sulfate 0.00388 MG/ML / hyoscyamine sulfate 0.0207 MG/ML / phenobarbital 3.24 MG/ML / scopolamine hydrobromide 0.0013 MG/ML Oral Solution | SCD | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046787 | atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG per 5 ML Oral Solution | SY | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046924 | Donnatal (atropine sulfate 0.00388 MG / hyoscyamine sulfate 0.0207 MG / phenobarbital 3.24 MG / scopolamine hydrobromide 0.0013 MG) per ML Oral Solution | SY | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046924 | Donnatal (atropine sulfate 0.0194 MG / hyoscyamine sulfate 0.1037 MG / phenobarbital 16.2 MG / scopolamine hydrobromide 0.0065 MG) per 5 ML Oral Solution | SY | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
| 1046924 | Donnatal (atropine sulfate 0.0388 MG / hyoscyamine sulfate 0.2074 MG / phenobarbital 32.4 MG / scopolamine hydrobromide 0.013 MG) per 10 ML Oral Solution | SY | 5d69ffc1-4608-4d73-ae91-838983bcf98d | 16 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 17856-0423-2 | 17856042302 | 15 mL in 1 CUP | 15 ml | Historical |
| 17856-0423-3 | 17856042303 | 10 mL in 1 CUP | 10 ml | Historical |
| 17856-0423-4 | 17856042304 | 5 mL in 1 CUP | 5 ml | Historical |
| 17856-0423-5 | 17856042305 | 5 mL in 1 CUP | 5 ml | Historical |
| 17856-0423-6 | 17856042306 | 5 mL in 1 CUP | 5 ml | Historical |
| 17856-0423-8 | 17856042308 | 15 mL in 1 CUP | 15 ml | Historical |
| 17856-0423-9 | 17856042309 | 10 mL in 1 CUP | 10 ml | Historical |