Home NDC 56062-057 profen ib
Product NDC 56062-057
11-digit product format 560620057
Labeler code 56062
Product ID 56062-057_44e24e10-b8fa-4992-a35f-01c664914844
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Publix Super Markets Inc
Application ANDA075217
Marketing category ANDA
Marketing start 2001-06-29
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 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 A075217-001 IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16
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 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base profen ib
Brand name suffix infants
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 56062-057-05 profen ibinfants 1 in 1 CARTON SUSPENSION 1 5 56062-057-05 profen ibinfants 15 mL in 1 BOTTLE SUSPENSION 15 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 56062-057 PROFEN IB INFANTS (IBUPROFEN) SUSPENSION [PUBLIX SUPER MARKETS INC] 4 Current NDC, Legacy NDC, 2 package rows 20181103_84aea3fc-4f3b-4a76-a3a6-94ed6549dbea.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 2 · 30 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 56062-057-05 56062005705 1 BOTTLE in 1 CARTON (56062-057-05) / 15 mL in 1 BOTTLE 1 bottle 2001-06-29 0000-00-00 No No Current