PROMETHAZINE DM
- Product NDC
- 0603-1586
- 11-digit product format
- 006031586
- Labeler code
- 0603
- Product ID
- 0603-1586_d7b7c392-ab9b-4c2a-abf2-b24b1d697b49
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide and Promethazine Hydrochloride
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Par Pharmaceutical
- Application
- ANDA040649
- Marketing category
- ANDA
- Marketing start
- 2006-02-14
- Marketing end
- 2020-08-21
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
- Active strength
- 15 mg/5mL; mg/5mL
- Pharmacologic classes
- Phenothiazine [EPC],Phenothiazines [CS],Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC],Sigma-1 Agonist [EPC],Uncompetitive NMDA Receptor Antagonists [MoA],Sigma-1 Receptor Agonists [MoA]
- 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 | 0603-1586 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 0603-1586 | 0603-1586-54 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 0603-1586 | 0603-1586-58 | D | Discontinued by firm | 2026-08-11 |
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 | 0603-1586-54 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0603-1586-58 | 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 | 0603-1586-54 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0603-1586-58 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040649-001 | PROMETHAZINE DM | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040649-001 | AA |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | 2006-02-14 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | 2006-02-14 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | 2006-02-14 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | 2006-02-14 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040649-001 | PROMETHAZINE DM | 15MG/5ML;6.25MG/5ML | SYRUP / ORAL | AA | RS | 2006-02-14 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A040649-001 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040649-001 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040649-001 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040649-001 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040649-001 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040649-001 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040649-001 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040649-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040649-001 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040649-001 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040649-001 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040649-001 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040649-001 | AA | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A040649-001 | AA | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A040649-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A040649-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A040649-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-03-09 01:35 UTC | 2022-03 | A040649-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A040649-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A040649-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A040649-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A040649-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A040649-001 | AA | 1 | c0c555d07b60… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A040649-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A040649-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A040649-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A040649-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A040649-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A040649-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A040649-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A040649-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A040649-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A040649-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A040649-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A040649-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A040649-001 | AA | 1 | cb3db0bc1861… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A040649-001 | AA | 1 | a50c72e98297… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 3036445d-7d13-4411-a100-f2ac5ab8a276 | Product name | 1 | 20240110 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| 2e7222fb-e3f1-febd-962f-ddbb495d6b5f | Product name | 2 | 20220126 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| c5cd4727-ac49-4409-82b1-5bd8006c3ec7 | Product name | 1 | 20171122 |
| 4f881de7-085a-407e-abc2-faa3c0127432 | Product name | 1 | 20170811 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
| d51697af-7f97-0559-95d1-fe94f3f031d5 | Product name | 1 | 20140508 |
| e949165d-714d-e548-2b76-0cb5def16f30 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0603-1586-54 | ML - Milliliter | 0603-1586 | 8d954c2a-2560-495d-9293-67a3689454d7 | 1 | 2012-07-24 |
| 0603-1586-58 | ML - Milliliter | 0603-1586 | 7f6a908b-b62d-4126-a6d0-f657c6a0f6f4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | ATLANTIC BIOLOGICALS CORP. | 3983d6d3-8bf4-4a88-962f-9bf72fd6e685 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Preferred Pharmaceuticals Inc. | 88137097-16b3-44b7-8e1f-26a8242d8179 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
| Promethazine DM | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | PAI Holdings, LLC dba PAI Pharma | 1d47280d-28c9-4701-8c5f-a6e6b524083b | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | NuCare Pharmaceuticals,Inc. | 0b7bfbab-decb-970c-e063-6394a90a50ef | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL | A-S Medication Solutions | 9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25 | 2023-08-10 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Proficient Rx LP | 68a4c521-6db0-4e94-9906-96e96e251301 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 040649 ANDA040649 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 39741361-ab78-4551-a6f9-432490a8f0b1 | 11 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 39741361-ab78-4551-a6f9-432490a8f0b1 | 11 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | 39741361-ab78-4551-a6f9-432490a8f0b1 | 11 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | 5d035ba4-7d6d-4842-b34f-691c26749b33 | 3 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | b84e85a1-70f3-4223-b77a-5b46b328303f | 2 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | b84e85a1-70f3-4223-b77a-5b46b328303f | 2 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | b84e85a1-70f3-4223-b77a-5b46b328303f | 2 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 5024bf2c-d0f8-4838-8d93-d435bad05803 | 1 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | 3f047079-1957-41e6-bf81-3f6d2e55b5af | 1 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | ade55a52-2d70-4c4a-bc91-b819161ceac6 | 1 |
| 991528 | promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution | PSN | d2853595-d913-4332-b15f-49211a7b6667 | 1 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 5024bf2c-d0f8-4838-8d93-d435bad05803 | 1 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | 3f047079-1957-41e6-bf81-3f6d2e55b5af | 1 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | ade55a52-2d70-4c4a-bc91-b819161ceac6 | 1 |
| 991528 | dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution | SCD | d2853595-d913-4332-b15f-49211a7b6667 | 1 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | 5024bf2c-d0f8-4838-8d93-d435bad05803 | 1 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | 3f047079-1957-41e6-bf81-3f6d2e55b5af | 1 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | ade55a52-2d70-4c4a-bc91-b819161ceac6 | 1 |
| 991528 | dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution | SY | d2853595-d913-4332-b15f-49211a7b6667 | 1 |