Home NDC 72260-129-16 Combogesic
Product NDC 72260-129
Requested package NDC 72260-129-16
11-digit product format 722600129
Labeler code 72260
Product ID 72260-129_a986b143-6085-48bb-b0a6-b95f3c1644cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACETAMINOPHEN and IBUPROFEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AFT Pharmaceuticals US, Inc.
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table 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# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table 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# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table 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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 N209471-001 COMBOGESIC 325MG;97.5MG TABLET / ORAL RLD, RS 2023-03-01 c2088c7a36db…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# Patent history page 1 of 2 · 73 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N209471-001 11197830 2039-02-27 U-3553 Drug product 2023-03-29 c2088c7a36db…2026-10-15 13:18:30 2026-09 N209471-001 11534407 2039-02-27 U-3553 Drug product 2023-03-29 c2088c7a36db…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…
Observed Orange Book exclusivity history# 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 table Ingredient Strength ACETAMINOPHEN 325 mg/1 IBUPROFEN 97.5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72260-129-01 Combogesic 250 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 250 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72260-129 COMBOGESIC (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [AFT PHARMACEUTICALS US, INC.] 5 Current NDC, 1 package rows 20250116_f863558f-2a44-41f8-a6b7-271851d4c2ff.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.
Matched openFDA labels page 1 of 1 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72260-129-16 72260012916 1 BLISTER PACK in 1 CARTON (72260-129-16) / 6 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2026-10-09 Yes No Current