Home NDC 58602-895-85 Acetaminophen and Ibuprofen Back Pain
Product NDC 58602-895
Requested package NDC 58602-895-85
11-digit product format 586020895
Labeler code 58602
Product ID 58602-895_358fae0b-3a56-4ffa-ba09-de83cd8200a5
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurohealth LLC
Application ANDA218359
Marketing category ANDA
Marketing start 2024-03-26
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 2027-12-31
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 A218359-001 ACETAMINOPHEN AND IBUPROFEN ACETAMINOPHEN; IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26
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 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218359-001 ACETAMINOPHEN AND IBUPROFEN 250MG;125MG TABLET / ORAL 2024-03-26 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 Acetaminophen and Ibuprofen Back Pain
Listing expiration 2027-12-31 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 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 58602-895-01 Acetaminophen and Ibuprofen Back Pain 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 2 58602-895-01 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-03 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-03 Acetaminophen and Ibuprofen Back Pain 10 in 1 BOTTLE TABLET, FILM COATED 10 2 58602-895-07 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-07 Acetaminophen and Ibuprofen Back Pain 24 in 1 BOTTLE TABLET, FILM COATED 24 2 58602-895-11 Acetaminophen and Ibuprofen Back Pain 36 in 1 BOTTLE TABLET, FILM COATED 36 2 58602-895-11 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-14 Acetaminophen and Ibuprofen Back Pain 50 in 1 BOTTLE TABLET, FILM COATED 50 2 58602-895-14 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-21 Acetaminophen and Ibuprofen Back Pain 100 in 1 BOTTLE TABLET, FILM COATED 100 2 58602-895-21 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-29 Acetaminophen and Ibuprofen Back Pain 150 in 1 BOTTLE TABLET, FILM COATED 150 2 58602-895-29 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-35 Acetaminophen and Ibuprofen Back Pain 225 in 1 BOTTLE TABLET, FILM COATED 225 2 58602-895-40 Acetaminophen and Ibuprofen Back Pain 500 in 1 BOTTLE TABLET, FILM COATED 500 2 58602-895-41 Acetaminophen and Ibuprofen Back Pain 1000 in 1 BOTTLE TABLET, FILM COATED 1000 2 58602-895-44 Acetaminophen and Ibuprofen Back Pain 400 in 1 BOTTLE TABLET, FILM COATED 400 2 58602-895-46 Acetaminophen and Ibuprofen Back Pain 18 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 18 2 58602-895-46 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-49 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-49 Acetaminophen and Ibuprofen Back Pain 10 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 10 2 58602-895-51 Acetaminophen and Ibuprofen Back Pain 216 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 216 2 58602-895-61 Acetaminophen and Ibuprofen Back Pain 2 in 1 BLISTER PACK TABLET, FILM COATED 2 2 58602-895-61 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-62 Acetaminophen and Ibuprofen Back Pain 216 in 1 BOTTLE TABLET, FILM COATED 216 2 58602-895-65 Acetaminophen and Ibuprofen Back Pain 72 in 1 BOTTLE TABLET, FILM COATED 72 2 58602-895-65 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-73 Acetaminophen and Ibuprofen Back Pain 20 in 1 BOTTLE TABLET, FILM COATED 20 2 58602-895-73 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-78 Acetaminophen and Ibuprofen Back Pain 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 2 58602-895-78 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-79 Acetaminophen and Ibuprofen Back Pain 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 2 58602-895-80 Acetaminophen and Ibuprofen Back Pain 72 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 72 2 58602-895-80 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-82 Acetaminophen and Ibuprofen Back Pain 18 in 1 BOTTLE TABLET, FILM COATED 18 2 58602-895-82 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-84 Acetaminophen and Ibuprofen Back Pain 225 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 225 2 58602-895-85 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-85 Acetaminophen and Ibuprofen Back Pain 36 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 36 2 58602-895-88 Acetaminophen and Ibuprofen Back Pain 750 in 1 BOTTLE TABLET, FILM COATED 750 2 58602-895-94 Acetaminophen and Ibuprofen Back Pain 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 2 58602-895-94 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-95 Acetaminophen and Ibuprofen Back Pain 750 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 750 2 58602-895-96 Acetaminophen and Ibuprofen Back Pain 1 in 1 CARTON TABLET, FILM COATED 1 2 58602-895-96 Acetaminophen and Ibuprofen Back Pain 20 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 20 2 58602-895-99 Acetaminophen and Ibuprofen Back Pain 400 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 400 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-895 ACETAMINOPHEN AND IBUPROFEN BACK PAIN (ACETAMINOPHEN AND IBUPROFEN) TABLET, FILM COATED [AUROHEALTH LLC] 1 Current NDC, 47 package rows 20240404_62d7ce90-63a4-4383-87c9-3a458eac29bf.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 58602-895-85 58602089585 1 BOTTLE, PLASTIC in 1 CARTON (58602-895-85) / 36 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2024-03-26 No No Current