PHENOBARBITAL WITH BELLADONNA ALKALOIDS
- Product NDC
- 71914-162
- 11-digit product format
- 719140162
- Labeler code
- 71914
- Product ID
- 71914-162_b64e611a-1464-43e4-9b41-38dda6212527
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PHENOBARBITAL WITH BELLADONNA ALKALOIDS
- Dosage form
- ELIXIR
- Route
- ORAL
- Labeler
- Lazarus Pharmaceuticals, Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2018-04-20
- Marketing end
- 2021-07-29
- Substance
- PHENOBARBITAL; HYOSCYAMINE SULFATE; ATROPINE SULFATE; SCOPOLAMINE HYDROBROMIDE
- Active strength
- 16 mg/5mL; mg/5mL; mg/5mL; mg/5mL
- Pharmacologic classes
- Anticholinergic [EPC],Cholinergic Antagonists [MoA],Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA],Anticholinergic [EPC],Cholinergic Antagonists [MoA]
- DEA schedule
- CIV
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 | 71914-162 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 71914-162 | 71914-162-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71914-162 | 71914-162-04 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71914-162 | 71914-162-10 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 71914-162 | 71914-162-16 | D | Discontinued by firm | 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 package | package | 71914-162-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71914-162-10 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71914-162-04 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71914-162-10 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71914-162-04 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71914-162-10 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71914-162-04 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71914-162-10 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71914-162-04 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71914-162-10 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71914-162-04 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71914-162-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71914-162-04 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71914-162-10 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71914-162-04 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71914-162-10 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71914-162-04 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71914-162-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71914-162-04 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71914-162-10 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71914-162-04 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 71914-162-10 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 71914-162-04 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 71914-162-16 | 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 package | package | 71914-162-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71914-162-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71914-162-04 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 71914-162-16 | 557ba5c1ecfa… | 9c80585c8c6e… |
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 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 71914-162-01 | ML - Milliliter | 71914-162 | 4fb35c46-4644-435f-9443-c4768e8b5663 | 1 | 2019-08-06 |
| 71914-162-04 | ML - Milliliter | 71914-162 | 9555bf51-b9ab-4a9d-bbaa-d66461a13516 | 1 | 2018-06-11 |
| 71914-162-10 | ML - Milliliter | 71914-162 | a7b71f0f-2e82-48ed-a72b-5474864244b6 | 1 | 2019-08-06 |
| 71914-162-16 | ML - Milliliter | 71914-162 | 953bbdb9-326b-4369-a4ee-bf0a83eab4c3 | 1 | 2018-06-11 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 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 | 6186eca3-be71-48d6-b102-de15746f49e7 | 2 |
| 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 | 6186eca3-be71-48d6-b102-de15746f49e7 | 2 |
| 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 | 6186eca3-be71-48d6-b102-de15746f49e7 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 71914-162-01 | 71914016201 | 5 mL in 1 CUP, UNIT-DOSE (71914-162-01) | 5 ml | 2019-06-11 | 2021-07-29 | No | No | Current |
| 71914-162-04 | 71914016204 | 120 mL in 1 BOTTLE (71914-162-04) | 120 ml | 2018-04-20 | 2021-07-29 | No | No | Current |
| 71914-162-10 | 71914016210 | 1 TRAY in 1 CASE (71914-162-10) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (71914-162-01) | 1 tray | 2019-06-11 | 2021-07-29 | No | No | Current |
| 71914-162-16 | 71914016216 | 473 mL in 1 BOTTLE (71914-162-16) | 473 ml | 2018-04-20 | 2021-07-29 | No | No | Current |