Donnatal
- Product NDC
- 66213-423
- 11-digit product format
- 662130423
- Labeler code
- 66213
- Product ID
- 66213-423_f2607865-8e51-4fc8-a703-b9eb499f890d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENOBARBITAL ELIXIR
- Dosage form
- ELIXIR
- Route
- ORAL
- Labeler
- PBM Pharmaceuticals Inc.
- 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]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- 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 | 66213-423 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded product | product | 66213-423 | I | Inactivated by FDA | 2026-10-05 | ||
| excluded package | package | 66213-423 | 66213-423-16 | I | Inactivated by FDA | 2026-10-05 | |
| excluded package | package | 66213-423 | 66213-423-04 | I | Inactivated by FDA | 2026-10-05 |
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 | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 66213-423-16 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 66213-423-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 66213-423-16 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 66213-423-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 66213-423-16 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 66213-423-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 66213-423-16 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 66213-423-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 66213-423-16 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 66213-423-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 66213-423-16 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 66213-423-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 66213-423-16 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 66213-423-04 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 66213-423-16 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 66213-423-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66213-423-16 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 66213-423-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 66213-423-16 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 66213-423-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 66213-423-16 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 66213-423-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66213-423-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 66213-423-04 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66213-423-16 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 66213-423-04 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66213-423-16 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 66213-423-04 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66213-423-16 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 66213-423-04 | 1332a3947898… | d4bfe170f9cd… |
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#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 66213-423-04 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-3d20-60a7-e053-dbdaa90a05bd | Donnatal Elixir 4oz grape flavor |
| 66213-423-16 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-49f2-60a7-e053-dbdaa90a05bd | DONNATAL ELIXIR grape flavor 1 pint |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66213-423-04 | Donnatal | 118 mL in 1 BOTTLE | ELIXIR | 118 | 7 | |
| 66213-423-16 | Donnatal | 473 mL in 1 BOTTLE | ELIXIR | 473 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 66213-423-04 | ML - Milliliter | 66213-423 | b93778ff-3bee-4128-b07e-5c69d7212176 | 1 | 2012-07-24 |
| 66213-423-16 | ML - Milliliter | 66213-423 | 735af8bf-b0b1-413e-abc3-5abecbb15b83 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 66213-423 | DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.] | 7 | Legacy NDC, 1 package rows | 20131204_faa67498-fdff-4fe7-9057-2045e9463c32.zip |
| 66213-423 | DONNATAL (PHENOBARBITAL ELIXIR) ELIXIR [PBM PHARMACEUTICALS INC.] | 7 | Legacy NDC, 1 package rows | 20131203_8ca66d68-b1fe-40eb-b1c4-93bf45dc0709.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 |
| 1046924 | Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution | PSN | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 1046924 | Donnatal 16.2 MG / 0.1037 MG / 0.0194 MG / 0.0065 MG in 5 mL Oral Solution | PSN | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | faa67498-fdff-4fe7-9057-2045e9463c32 | 7 |
| 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 | 8ca66d68-b1fe-40eb-b1c4-93bf45dc0709 | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 66213-423-04 | 66213042304 | 118 mL in 1 BOTTLE | 118 ml | Historical |
| 66213-423-16 | 66213042316 | 473 mL in 1 BOTTLE | 473 ml | Historical |