good sense pain relief
- Product NDC
- 0113-0544
- 11-digit product format
- 001130544
- Labeler code
- 0113
- Product ID
- 0113-0544_41fd59e2-2325-4adc-b754-55c23a8f6a2c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- L. Perrigo Company
- Application
- ANDA075077
- Marketing category
- ANDA
- Marketing start
- 2005-11-21
- Substance
- ACETAMINOPHEN
- Active strength
- 650 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 package | package | 0113-0544 | 0113-0544-62 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0113-0544 | 0113-0544-71 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0113-0544 | 0113-0544-79 | D | Discontinued by firm | 2026-08-03 |
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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0113-0544-79 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0113-0544-62 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | 0113-0544-71 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0113-0544-79 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0113-0544-62 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | 0113-0544-71 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0113-0544-79 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 0113-0544-62 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0113-0544-79 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | 0113-0544-62 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0113-0544-79 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | 0113-0544-62 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0113-0544-79 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | 0113-0544-62 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0113-0544-79 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 0113-0544-62 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0113-0544-79 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | 0113-0544-62 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0113-0544-79 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0113-0544-62 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0113-0544-79 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | 0113-0544-62 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0113-0544-79 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 0113-0544-62 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0113-0544-79 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 0113-0544-62 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075077-001 | ACETAMINOPHEN | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 |
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 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075077-001 | ACETAMINOPHEN | 650MG | TABLET, EXTENDED RELEASE / ORAL | 2000-02-25 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- good sense pain relief
- Brand name suffix
- arthritis pain
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 650 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1148399 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 236eedd4-6ece-46ce-9ab3-12366d57126b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0113-0544-62 | good sense pain reliefarthritis pain | 24 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 24 | 9 | |
| 0113-0544-62 | good sense pain reliefarthritis pain | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 9 | |
| 0113-0544-71 | good sense pain reliefarthritis pain | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 9 | |
| 0113-0544-71 | good sense pain reliefarthritis pain | 50 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 50 | 9 | |
| 0113-0544-78 | good sense pain reliefarthritis pain | 1 in 1 CARTON | TABLET, FILM COATED, EXTENDED RE | 1 | 9 | |
| 0113-0544-78 | good sense pain reliefarthritis pain | 100 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 100 | 9 | |
| 0113-0544-79 | good sense pain reliefarthritis pain | 400 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 400 | 9 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0113-0544-62 | EA - Each | 0113-0544 | 0ed9b51c-5183-4d3c-98bc-b4d389e1dd8a | 1 | 2012-07-24 |
| 0113-0544-71 | EA - Each | 0113-0544 | 303a473a-8f68-401c-9d71-7a56f2356fcd | 1 | 2012-07-24 |
| 0113-0544-78 | EA - Each | 0113-0544 | c7c587b2-5823-4d0b-93f9-32cc106c6093 | 1 | 2016-09-02 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0113-0544 | GOOD SENSE PAIN RELIEF ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [L. PERRIGO COMPANY] | 7 | Current NDC, Legacy NDC, 7 package rows | 20221122_236eedd4-6ece-46ce-9ab3-12366d57126b.zip |
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.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 236eedd4-6ece-46ce-9ab3-12366d57126b | 9 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 236eedd4-6ece-46ce-9ab3-12366d57126b | 9 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 236eedd4-6ece-46ce-9ab3-12366d57126b | 9 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 236eedd4-6ece-46ce-9ab3-12366d57126b | 9 |
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 7b0b07f6-242a-4e1a-ab39-84f0334d4716 | 2 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 7b0b07f6-242a-4e1a-ab39-84f0334d4716 | 2 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 7b0b07f6-242a-4e1a-ab39-84f0334d4716 | 2 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 7b0b07f6-242a-4e1a-ab39-84f0334d4716 | 2 |
| 1148399 | acetaminophen 650 MG 8HR Extended Release Oral Tablet | PSN | 2315ec07-e5b8-4332-8bc2-4e28e88892f3 | 1 |
| 1148399 | 8 HR acetaminophen 650 MG Extended Release Oral Tablet | SCD | 2315ec07-e5b8-4332-8bc2-4e28e88892f3 | 1 |
| 1148399 | 8 HR APAP 650 MG Extended Release Oral Tablet | SY | 2315ec07-e5b8-4332-8bc2-4e28e88892f3 | 1 |
| 1148399 | acetaminophen 650 MG 8 HR Extended Release Oral Tablet | SY | 2315ec07-e5b8-4332-8bc2-4e28e88892f3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0113-0544-62 | 00113054462 | 1 BOTTLE in 1 CARTON (0113-0544-62) > 24 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2005-11-21 | 2024-03-31 | No | No | Current |
| 0113-0544-71 | 00113054471 | 1 BOTTLE in 1 CARTON (0113-0544-71) > 50 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2005-11-25 | 0000-00-00 | No | No | Current |
| 0113-0544-78 | 00113054478 | 1 BOTTLE in 1 CARTON (0113-0544-78) / 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 2009-09-02 | 0000-00-00 | No | No | Current |
| 0113-0544-79 | 00113054479 | 400 in 1 BOTTLE | Historical |