Home NDC 58602-858 Ibuprofen Minis
Product NDC 58602-858
11-digit product format 586020858
Labeler code 58602
Product ID 58602-858_d0b03d99-477f-4250-ac84-576b1baf2eed
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Aurohealth LLC
Application ANDA215777
Marketing category ANDA
Marketing start 2023-09-14
Substance IBUPROFEN
Active strength 200 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 A215777-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14
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 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215777-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2023-09-14 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen Minis
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 310964 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 58602-858-12 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-12 Ibuprofen Minis 40 in 1 BOTTLE CAPSULE, LIQUID FILLED 40 1 58602-858-18 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-18 Ibuprofen Minis 80 in 1 BOTTLE CAPSULE, LIQUID FILLED 80 1 58602-858-23 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-23 Ibuprofen Minis 120 in 1 BOTTLE CAPSULE, LIQUID FILLED 120 1 58602-858-30 Ibuprofen Minis 160 in 1 BOTTLE CAPSULE, LIQUID FILLED 160 1 58602-858-34 Ibuprofen Minis 200 in 1 BOTTLE CAPSULE, LIQUID FILLED 200 1 58602-858-42 Ibuprofen Minis 240 in 1 BOTTLE CAPSULE, LIQUID FILLED 240 1 58602-858-70 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-70 Ibuprofen Minis 40 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 40 1 58602-858-72 Ibuprofen Minis 80 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 80 1 58602-858-72 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-73 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-73 Ibuprofen Minis 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 1 58602-858-80 Ibuprofen Minis 200 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 200 1 58602-858-96 Ibuprofen Minis 20 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 20 1 58602-858-96 Ibuprofen Minis 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1 58602-858-98 Ibuprofen Minis 240 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 240 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-858 IBUPROFEN MINIS (IBUPROFEN) CAPSULE, LIQUID FILLED [AUROHEALTH LLC] 1 Current NDC, 19 package rows 20230917_d0b03d99-477f-4250-ac84-576b1baf2eed.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 Units Marketing start Sample Exclude flag Status 58602-858-12 58602085812 1 BOTTLE in 1 CARTON (58602-858-12) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2023-09-14 No No Current 58602-858-18 58602085818 1 BOTTLE in 1 CARTON (58602-858-18) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2023-09-14 No No Current 58602-858-23 58602085823 1 BOTTLE in 1 CARTON (58602-858-23) / 120 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2023-09-14 No No Current 58602-858-30 58602085830 160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-30) 2023-09-14 No No Current 58602-858-34 58602085834 200 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-34) 2023-09-14 No No Current 58602-858-42 58602085842 240 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-858-42) 2023-09-14 No No Current 58602-858-70 58602085870 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-70) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2023-09-14 No No Current 58602-858-72 58602085872 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-72) / 80 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2023-09-14 No No Current 58602-858-73 58602085873 1 BOTTLE in 1 CARTON (58602-858-73) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2023-09-14 No No Current 58602-858-80 58602085880 200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-80) 2023-09-14 No No Current 58602-858-96 58602085896 1 BOTTLE, PLASTIC in 1 CARTON (58602-858-96) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC 2023-09-14 No No Current 58602-858-98 58602085898 240 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (58602-858-98) 2023-09-14 No No Current