Home NDC 58602-227 Infants Ibuprofen
Product NDC 58602-227
11-digit product format 586020227
Labeler code 58602
Product ID 58602-227_2a48af51-23e2-4fec-a76b-eef1611750f5
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Aurohealth LLC
Application ANDA213506
Marketing category ANDA
Marketing start 2024-04-08
Substance IBUPROFEN
Active strength 50 mg/1.25mL
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 A213506-001 IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08
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 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213506-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 2024-04-08 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 Infants Ibuprofen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 50 mg/1.25mL
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 204442 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 58602-227-04 Infants Ibuprofen 1 in 1 CARTON SUSPENSION 1 1 58602-227-04 Infants Ibuprofen 15 mL in 1 BOTTLE SUSPENSION 15 1 58602-227-07 Infants Ibuprofen 30 mL in 1 BOTTLE SUSPENSION 30 1 58602-227-07 Infants Ibuprofen 1 in 1 CARTON SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58602-227 INFANTS IBUPROFEN (IBUPROFEN) SUSPENSION [AUROHEALTH LLC] 1 Current NDC, 4 package rows 20240418_2a48af51-23e2-4fec-a76b-eef1611750f5.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 · 1 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 58602-227-04 58602022704 1 BOTTLE in 1 CARTON (58602-227-04) / 15 mL in 1 BOTTLE 1 bottle 2024-04-08 No No Current 58602-227-07 58602022707 1 BOTTLE in 1 CARTON (58602-227-07) / 30 mL in 1 BOTTLE 1 bottle 2024-04-08 No No Current