Home NDC 42507-461-62 ibuprofen
Product NDC 42507-461
Requested package NDC 42507-461-62
11-digit product format 425070461
Labeler code 42507
Product ID 42507-461_b2295ddf-f7d7-4fdb-8864-aa9dfebb3f4f
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler HyVee Inc
Application ANDA076359
Marketing category ANDA
Marketing start 2005-02-12
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 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…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…
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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 42507-461-24 ibuprofen 24 in 1 BOTTLE TABLET, CHEWABLE 24 3 42507-461-62 ibuprofen 1 in 1 CARTON TABLET, CHEWABLE 1 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 ASPARTAME INACTIVE INGREDIENT Z0H242BBR1 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 SOYBEAN OIL INACTIVE INGREDIENT 241ATL177A IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1 SUCCINIC ACID INACTIVE INGREDIENT AB6MNQ6J6L IBUPROFEN TABLET, CHEWABLE [HYVEE INC] 1
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 42507-461-62 42507046162 1 BOTTLE in 1 CARTON (42507-461-62) / 24 TABLET, CHEWABLE in 1 BOTTLE (42507-461-24) 1 bottle 2005-02-12 No No Current