ACETAMINOPHEN AND CODEINE PHOSPHATE
- Product NDC
- 53217-370
- 11-digit product format
- 532170370
- Labeler code
- 53217
- Product ID
- 53217-370_329e0451-ea99-45a1-9a89-a06d3de0c492
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- acetaminophen and codeine phosphate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Aidarex Pharmaceuticals LLC
- Application
- ANDA040419
- Marketing category
- ANDA
- Marketing start
- 2018-04-03
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN; CODEINE PHOSPHATE
- Active strength
- 300 mg/1; mg/1
- Pharmacologic classes
- Full Opioid Agonists [MoA],Opioid Agonist [EPC]
- DEA schedule
- CIII
- 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 | 53217-370 | I | Inactivated by FDA | 2026-08-17 | ||
| excluded package | package | 53217-370 | 53217-370-20 | I | Inactivated by FDA | 2026-08-17 |
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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 | 53217-370-20 | 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 package | package | 53217-370-20 | 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 package | package | 53217-370-20 | 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 package | package | 53217-370-20 | 1332a3947898… | d4bfe170f9cd… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 53217-370-20 | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 53217-370-20 | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 53217-370-20 | bd6a592717d7… | 303034d00443… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 53217-370-20 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 53217-370-20 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 53217-370-20 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 |
| A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 |
| A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A040419-001 | AA |
| A040419-002 | AA |
| A040419-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-002 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;30MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-003 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;60MG | TABLET / ORAL | AA | RS | 2001-05-31 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-001 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 300MG;15MG | TABLET / ORAL | AA | RS | 2001-05-31 | 1e350fbaab3a… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A040419-001 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-002 | AA | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A040419-003 | AA | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-001 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-002 | AA | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A040419-003 | AA | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-001 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-002 | AA | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A040419-003 | AA | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-001 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-002 | AA | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A040419-003 | AA | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-001 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-002 | AA | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A040419-003 | AA | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-001 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-002 | AA | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A040419-003 | AA | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-001 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-002 | AA | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A040419-003 | AA | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-001 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-002 | AA | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A040419-003 | AA | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-001 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-002 | AA | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A040419-003 | AA | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-001 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-002 | AA | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A040419-003 | AA | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-001 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-002 | AA | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A040419-003 | AA | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-001 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-002 | AA | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A040419-003 | AA | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-001 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-002 | AA | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A040419-003 | AA | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A040419-001 | AA | 1 | 1e350fbaab3a… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 41b814f3-0166-1c53-c9ef-a0794c7daf9d | Product name | 3 | 20221110 |
| a590be26-846c-8659-a5a1-fb25907965dc | Product name | 2 | 20221110 |
| 09d8330d-4fec-be98-3a66-f985140646b2 | Product name | 2 | 20210513 |
| 20c8cafe-5cfc-44f8-a9be-a664f437f780 | Product name | 2 | 20200225 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814 | Product name | 3 | 20150910 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
| e9576821-a971-5261-628e-82ad9e10acdb | Product name | 2 | 20150121 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 30c51294-7ae9-8007-7de6-58222684a0be | Product name | 1 | 20140508 |
| 47fd879b-91c5-e1e5-130f-29d082a871ec | Product name | 1 | 20140508 |
| c35d1ac8-8885-2ee1-6c52-5a715b242c00 | Product name | 1 | 20140508 |
| ce055423-1d7f-3c41-dff1-83660fa8cd96 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 53217-370-20 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-8fc5-f424-e053-dadaa90a57ce | Acetaminophen and Codeine Phosphate Tablets USP CIII |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 53217-370-20 | ACETAMINOPHEN AND CODEINE PHOSPHATE | 20 in 1 BOTTLE | TABLET | 20 | 1 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | SpecGx LLC | eadc80fa-13c3-471a-a22f-6fe7e1ab290f | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Unit Dose Solutions, Inc. | 537245e8-5e2a-c3e0-e063-6394a90ac858 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | St. Mary's Medical Park Pharmacy | eac5f350-93e5-4dc2-e053-2a95a90aed60 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | REMEDYREPACK INC. | 5c96d033-bf7c-47de-aa0d-5998b3bf4a63 | 2026-02-03 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 9ca1321e-380a-48d7-8a58-c6501858c1c0 | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | dff53120-a609-4720-bd69-2391798c7dee | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | A-S Medication Solutions | 297dc9ff-e34f-434b-b1a4-4c995a5bac8b | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 55d494b1-c828-4841-8f64-75b92cd54cb6 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Preferred Pharmaceuticals Inc. | 2453d635-989d-4569-96b3-4efaf61cca71 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | a6e9b316-549d-4058-8c08-407e4ce5c255 | 2025-06-05 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE | ACETAMINOPHEN AND CODEINE | Direct_Rx | 8d7ca633-4448-3507-e053-2a95a90a1287 | 2025-04-29 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE | ACETAMINOPHEN AND CODEINE | Direct_Rx | 8d7d6fa4-cc9f-6b4b-e053-2995a90a7286 | 2025-02-19 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 73e2086e-f513-537f-e053-2991aa0a1348 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| Acetaminophen and Codeine Phosphate | ACETAMINOPHEN AND CODEINE PHOSPHATE | Direct_Rx | e78e50c0-36da-528e-e053-2995a90a3d80 | 2025-01-22 | Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Aphena Pharma Solutions - Tennessee, LLC | d53bf9b7-1652-4287-a0c1-e89f6f0cb7f1 | 2025-01-08 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Quality Care Products, LLC | 3b455938-7bbc-4626-939b-40b37709befb | 2024-12-16 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 3f7737d1-ec78-467e-8903-9cb8eba0ab0b | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Bryant Ranch Prepack | 18315a6f-9e89-46d7-81d3-905b8a51aa79 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | Proficient Rx LP | a8f8bb34-6d61-47a8-b58b-0b6763458052 | 2024-07-01 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN AND CODEINE PHOSPHATE | NuCare Pharmaceuticals,Inc. | 6f2ce909-6356-1c2c-e053-2a91aa0a0135 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | 040419 ANDA040419 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 993781 | codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet | PSN | b2d0594b-c8df-4d29-8292-a1626bf09c1f | 1 |
| 993781 | acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet | SCD | b2d0594b-c8df-4d29-8292-a1626bf09c1f | 1 |
| 993781 | APAP 300 MG / codeine phosphate 30 MG Oral Tablet | SY | b2d0594b-c8df-4d29-8292-a1626bf09c1f | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 53217-370-20 | 53217037020 | 20 in 1 BOTTLE | Historical |