Home NDC 58602-002 CHILDRENS IBUPROFEN
Product NDC 58602-002
11-digit product format 586020002
Labeler code 58602
Product ID 58602-002_9ce21c79-70e1-4d13-acec-fa431d358d64
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Aurohealth LLC
Application ANDA209179
Marketing category ANDA
Marketing start 2021-06-16
Substance IBUPROFEN
Active strength 100 mg/5mL
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 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 A209179-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17
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.
Product history page 1 of 2 · 41 observed 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 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209179-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-04-17 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base CHILDRENS IBUPROFEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/5mL
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 197803 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 58602-002-20 CHILDRENS IBUPROFEN 1 in 1 CARTON SUSPENSION 1 6 58602-002-20 CHILDRENS IBUPROFEN 240 mL in 1 BOTTLE SUSPENSION 240 6 58602-002-24 CHILDRENS IBUPROFEN 1 in 1 CARTON SUSPENSION 1 6 58602-002-24 CHILDRENS IBUPROFEN 120 mL in 1 BOTTLE SUSPENSION 120 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-002 CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [AUROHEALTH LLC] 4 Current NDC, Legacy NDC, 4 package rows 20240307_7461e50d-bfa1-4627-b691-089636b979d2.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 · 12 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58602-002-20 58602000220 1 BOTTLE in 1 CARTON (58602-002-20) / 240 mL in 1 BOTTLE 1 bottle 2021-06-16 0000-00-00 No No Current 58602-002-24 58602000224 1 BOTTLE in 1 CARTON (58602-002-24) / 120 mL in 1 BOTTLE 1 bottle 2021-06-16 0000-00-00 No No Current