Acetaminophen
- Product NDC
- 61010-4406
- 11-digit product format
- 610104406
- Labeler code
- 61010
- Product ID
- 61010-4406_31cf574b-6ae9-40dc-a823-8b48242910ca
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Safetec of America, Inc.
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2019-12-30
- Marketing end
- 0000-00-00
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 61010-4406 | I | Inactivated by FDA | 2026-10-16 | ||
| excluded package | package | 61010-4406 | 61010-4406-0 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 61010-4406 | 61010-4406-1 | I | Inactivated by FDA | 2026-10-16 | |
| excluded package | package | 61010-4406 | 61010-4406-2 | I | Inactivated by FDA | 2026-10-16 |
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 | 61010-4406-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61010-4406-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61010-4406-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61010-4406-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61010-4406-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61010-4406-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61010-4406-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61010-4406-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61010-4406-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61010-4406-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61010-4406-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61010-4406-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61010-4406-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61010-4406-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61010-4406-1 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 61010-4406-2 | 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 | 61010-4406-0 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61010-4406-1 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 61010-4406-2 | 1332a3947898… | d4bfe170f9cd… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61010-4406-0 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c87-111a-e063-dadaa90a10e2 | Drug Facts |
| 61010-4406-1 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c87-111a-e063-dadaa90a10e2 | Drug Facts |
| 61010-4406-2 | 2024-01-30 | C162847 | 48780-1 | 1030e365-4c87-111a-e063-dadaa90a10e2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61010-4406-0 | Acetaminophen | 2 in 1 POUCH | TABLET | 2 | 2 | |
| 61010-4406-1 | Acetaminophen | 50 in 1 BOX | TABLET | 50 | 2 | |
| 61010-4406-2 | Acetaminophen | 100 in 1 BOX | TABLET | 100 | 2 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61010-4406 | ACETAMINOPHEN TABLET [SAFETEC OF AMERICA, INC.] | 2 | Legacy NDC, 3 package rows | 20200116_67870e7a-88fd-43cf-97e8-cbf546ad4f3f.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 67870e7a-88fd-43cf-97e8-cbf546ad4f3f | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 67870e7a-88fd-43cf-97e8-cbf546ad4f3f | 2 |
| 198440 | APAP 500 MG Oral Tablet | SY | 67870e7a-88fd-43cf-97e8-cbf546ad4f3f | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61010-4406-0 | 61010440600 | 2 TABLET in 1 POUCH (61010-4406-0) | 2 tablet | 2019-12-30 | 0000-00-00 | No | No | Current |
| 61010-4406-1 | 61010440601 | 50 POUCH in 1 BOX (61010-4406-1) > 2 TABLET in 1 POUCH (61010-4406-0) | 50 pouch | 2019-12-30 | 0000-00-00 | No | No | Current |
| 61010-4406-2 | 61010440602 | 100 POUCH in 1 BOX (61010-4406-2) > 2 TABLET in 1 POUCH (61010-4406-0) | 100 pouch | 2019-12-30 | 0000-00-00 | No | No | Current |