Home NDC 11822-0897-4 ibuprofen
Product NDC 11822-0897
Requested package NDC 11822-0897-4
11-digit product format 118220897
Labeler code 11822
Product ID 11822-0897_afd61c83-27f9-418a-9635-d445e2da2b34
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Rite Aid Corporation
Application ANDA074937
Marketing category ANDA
Marketing start 1999-01-08
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 11822-0897 11822-0897-4 U Excluded because listing certification expired excluded / ndc_excluded.zip ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 11822-0897 11822-0897-4 U Excluded because listing certification expired excluded / ndc_excluded.zip 0efc9e666f02…f202fb6c5f17…
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 A074937-001 CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22
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 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base ibuprofen
Brand name suffix childrens
Listing expiration 2026-12-31 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 11822-0897-1 ibuprofenchildrens 150 mL in 1 BOTTLE SUSPENSION 150 7 11822-0897-1 ibuprofenchildrens 1 in 1 CARTON SUSPENSION 1 7 11822-0897-4 ibuprofenchildrens 120 mL in 1 BOTTLE SUSPENSION 120 7 11822-0897-4 ibuprofenchildrens 1 in 1 CARTON SUSPENSION 1 7 11822-0897-8 ibuprofenchildrens 1 in 1 CARTON SUSPENSION 1 7 11822-0897-8 ibuprofenchildrens 240 mL in 1 BOTTLE SUSPENSION 240 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11822-0897 IBUPROFEN CHILDRENS (IBUPROFEN) SUSPENSION [RITE AID CORPORATION] 7 Current NDC, Legacy NDC, 6 package rows 20250126_c6e68886-edcb-414d-9cba-0d97772ef8b6.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 5 · 82 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 11822-0897-4 11822089704 1 BOTTLE in 1 CARTON (11822-0897-4) / 120 mL in 1 BOTTLE 1 bottle 1999-01-08 0000-00-00 No No Current