Home NDC 69168-462 Dual Action Pain Relief
Product NDC 69168-462
11-digit product format 691680462
Labeler code 69168
Product ID 69168-462_cd52df09-a439-4a7e-b593-d2255f4a2275
Type HUMAN OTC DRUG
Nonproprietary name Dual Action Pain Relief
Dosage form CAPSULE
Route ORAL
Labeler Allegiant Health
Application ANDA216592
Marketing category ANDA
Marketing start 2024-03-29
Substance ACETAMINOPHEN; IBUPROFEN
Active strength 250; 125 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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A216592-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13
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 2026-02-19 14:30 UTC 2026-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216592-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2023-07-13 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Dual Action Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 IBUPROFEN 125 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup WK2XYI10QM Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 69168-462-02 Dual Action Pain Relief 150 in 1 BOTTLE CAPSULE 150 4 69168-462-17 Dual Action Pain Relief 300 in 1 BOTTLE CAPSULE 300 4 69168-462-35 Dual Action Pain Relief 80 in 1 BOTTLE CAPSULE 80 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-462 DUAL ACTION PAIN RELIEF CAPSULE [ALLEGIANT HEALTH] 4 Current NDC, 3 package rows 20250309_fb4fc347-0f90-429f-9ca8-903e736f5496.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 · 17 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69168-462-02 69168046202 150 CAPSULE in 1 BOTTLE (69168-462-02) 150 capsule 2024-03-29 No No Current 69168-462-17 69168046217 300 CAPSULE in 1 BOTTLE (69168-462-17) 300 capsule 2025-03-07 No No Current 69168-462-35 69168046235 80 CAPSULE in 1 BOTTLE (69168-462-35) 80 capsule 2024-03-29 No No Current