Home NDC 75907-158-14 Dual Action
Product NDC 75907-158
Requested package NDC 75907-158-14
11-digit product format 759070158
Labeler code 75907
Product ID 75907-158_ac5bcacf-74a8-2803-2157-fa190e092558
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/ 125 mg
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Inc
Application ANDA218247
Marketing category ANDA
Marketing start 2025-02-06
Substance IBUPROFEN; ACETAMINOPHEN
Active strength 125; 250 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 43 .
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 A218247-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23
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 2026-09-14 22:38:34 2026-08 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218247-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-08-23 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 Dual Action
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 125 mg/1 ACETAMINOPHEN 250 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WK2XYI10QM Internal UNII lookup 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2387532 Internal RxNorm 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 75907-158-14 Dual Action 144 in 1 BOTTLE TABLET, FILM COATED 144 2 75907-158-25 Dual Action 250 in 1 BOTTLE TABLET, FILM COATED 250 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 75907-158 DUAL ACTION (ACETAMINOPHEN AND IBUPROFEN (NSAID) TABLETS, 250 MG/ 125 MG) TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC] 1 Current NDC, 2 package rows 20250212_c8a8a18a-6766-37a9-d0f0-f9380fb5b0e8.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 75907-158-14 75907015814 144 TABLET, FILM COATED in 1 BOTTLE (75907-158-14) 2025-02-06 No No Current