Combogesic
- Product NDC
- 71335-3161
- 11-digit product format
- 713353161
- Labeler code
- 71335
- Product ID
- 71335-3161_be486843-8ad9-446b-b8de-9df5d5b5ba16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ACETAMINOPHEN and IBUPROFEN
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA209471
- Marketing category
- NDA
- Marketing start
- 2025-01-06
- Substance
- ACETAMINOPHEN; IBUPROFEN
- Active strength
- 325; 97.5 mg/1; mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
- 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 | 71335-3161 | 71335-3161-2 | D | Discontinued by firm | 2026-10-05 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N209471-001 | COMBOGESIC | ACETAMINOPHEN; IBUPROFEN | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 |
| N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N209471-001 | NP | 2026-03-01 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD | 2023-03-01 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | 053a50430f4f… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209471-001 | COMBOGESIC | 325MG;97.5MG | TABLET / ORAL | RLD, RS | 2023-03-01 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209471-001 | 11197830 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209471-001 | 11534407 | 2039-02-27 | U-3553 | Drug product | 2023-03-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209471-001 | 10532036 | 2025-09-22 | U-3553 | 2023-03-29 | 1e350fbaab3a… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N209471-001 | NP | 2026-03-01 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N209471-001 | NP | 2026-03-01 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N209471-001 | NP | 2026-03-01 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N209471-001 | NP | 2026-03-01 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N209471-001 | NP | 2026-03-01 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N209471-001 | NP | 2026-03-01 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N209471-001 | NP | 2026-03-01 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N209471-001 | NP | 2026-03-01 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N209471-001 | NP | 2026-03-01 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N209471-001 | NP | 2026-03-01 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N209471-001 | NP | 2026-03-01 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N209471-001 | NP | 2026-03-01 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N209471-001 | NP | 2026-03-01 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N209471-001 | NP | 2026-03-01 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N209471-001 | NP | 2026-03-01 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N209471-001 | NP | 2026-03-01 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N209471-001 | NP | 2026-03-01 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N209471-001 | NP | 2026-03-01 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N209471-001 | NP | 2026-03-01 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N209471-001 | NP | 2026-03-01 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N209471-001 | NP | 2026-03-01 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N209471-001 | NP | 2026-03-01 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N209471-001 | NP | 2026-03-01 | 3f0d92c62455… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N209471-001 | NP | 2026-03-01 | a50c72e98297… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Combogesic
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
| IBUPROFEN | 97.5 mg/1 |
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 |
|---|---|---|---|---|---|---|
| Combogesic | ACETAMINOPHEN AND IBUPROFEN | Preferred Pharmaceuticals Inc. | f3cee991-19ef-4a1c-bb14-cbc8b6f32776 | 2026-08-20 | Boxed warning, Warnings, Adverse reactions | 209471 NDA209471 |
| Combogesic | ACETAMINOPHEN AND IBUPROFEN | Preferred Pharmaceuticals Inc. | cd03b658-dba1-4a12-8f6f-ab00da499c05 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | 209471 NDA209471 |
| Combogesic | ACETAMINOPHEN AND IBUPROFEN | Hikma Pharmaceuticals USA Inc | b32651c4-7fa0-415b-91eb-854aa1c28f2a | 2025-01-14 | Boxed warning, Warnings, Adverse reactions | 209471 NDA209471 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 71335-3161-1 | 71335316101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3161-1) | 2026-07-27 | No | No | Current |
| 71335-3161-3 | 71335316103 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3161-3) | 2026-07-27 | No | No | Current |
| 71335-3161-4 | 71335316104 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3161-4) | 2026-07-27 | No | No | Current |