Home NDC 0363-1521 childrens ibuprofen 100
Product NDC 0363-1521
11-digit product format 003631521
Labeler code 0363
Product ID 0363-1521_188fced9-63e0-4911-8566-eacb143f1b71
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Walgreen Company
Application ANDA076359
Marketing category ANDA
Marketing start 2019-06-10
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 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 · 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 · 82 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 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…2019-12-13 00:20 UTC 2019-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076359-001 IBUPROFEN 50MG TABLET, CHEWABLE / ORAL 2004-01-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A076359-002 IBUPROFEN 100MG TABLET, CHEWABLE / ORAL RS 2004-01-16 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base childrens ibuprofen 100
Listing expiration 2026-12-31 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0363-1521-62 childrens ibuprofen 100 24 in 1 BOTTLE TABLET, CHEWABLE 24 6 0363-1521-62 childrens ibuprofen 100 1 in 1 CARTON TABLET, CHEWABLE 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0363-1521 CHILDRENS IBUPROFEN 100 (IBUPROFEN) TABLET, CHEWABLE [WALGREEN COMPANY] 5 Current NDC, Legacy NDC, 2 package rows 20250509_7b798146-393f-422c-87f0-0bf800df0c71.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 · 36 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 0363-1521-62 00363152162 1 BOTTLE in 1 CARTON (0363-1521-62) / 24 TABLET, CHEWABLE in 1 BOTTLE 1 bottle 2019-06-10 0000-00-00 No No Current