Home NDC 72288-320-62 CHILDRENS IBUPROFEN
Product NDC 72288-320
Requested package NDC 72288-320-62
11-digit product format 722880320
Labeler code 72288
Product ID 72288-320_512c2c7e-fc74-452c-83f5-8824ba78b1f4
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Amazon.com Services LLC
Application ANDA076359
Marketing category ANDA
Marketing start 2026-08-12
Substance IBUPROFEN
Active strength 100 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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076359-001 IBUPROFEN IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 A076359-002 IBUPROFEN IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16
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 3 · 88 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 2026-10-15 13:18:30 2026-09 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 4b0b4de00fa7…
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 CHILDRENS IBUPROFEN
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 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 310963 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 37 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72288-320-62 72288032062 1 BOTTLE in 1 CARTON (72288-320-62) / 24 TABLET, CHEWABLE in 1 BOTTLE (72288-320-00) 1 bottle 2026-08-12 No No Current