Home NDC 49035-438 Ibuprofen
Product NDC 49035-438
11-digit product format 490350438
Labeler code 49035
Product ID 49035-438_5466b324-a1b4-4cf9-a4f0-006124254bba
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Wal-Mart Stores Inc
Application ANDA075139
Marketing category ANDA
Marketing start 2004-03-11
Marketing end 2028-02-29
Substance IBUPROFEN
Active strength 200 mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
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 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 A075139-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 1999-03-01
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 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075139-001 IBUPROFEN 200MG TABLET / ORAL 1999-03-01 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen
Brand name suffix Dye-Free Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 200 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 310965 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 49035-438-12 IbuprofenDye-Free 1 in 1 CARTON TABLET, FILM COATED 1 16 49035-438-12 IbuprofenDye-Free 100 in 1 BOTTLE TABLET, FILM COATED 100 16 49035-438-90 IbuprofenDye-Free 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49035-438 IBUPROFEN DYE-FREE (IBUPROFEN) TABLET, FILM COATED [WAL-MART STORES INC] 14 Current NDC, Legacy NDC, 3 package rows 20240913_23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6.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 · 26 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Better Living Brands, LLC 45520969-7a2d-4469-ba25-7db160d50ccf 2026-07-06 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 027ded51-aa01-6619-3938-c8162a421cf3 2026-06-18 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 110, LLC. DBA Leader a41a0bc2-ef7a-44cd-a42e-aefab41323cc 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN ARMY AND AIR FORCE EXCHANGE SERVICE 01f8fe3a-8810-4b38-8860-d95e05d37709 2026-06-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Cardinal Health 107, LLC 260f5862-d65d-4c34-bf53-26ca30806a67 2026-05-19 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution, Inc. 3e3a5366-535d-45fb-81af-c7d98ac20b11 2026-05-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye Free IBUPROFEN CVS Pharmacy 00653b7c-7099-487e-9a01-e89781c21323 2026-04-29 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Meijer Distribution Inc 36f7227d-f3cb-44b7-a4c1-27611cd15052 2026-04-24 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Rite Aid Corporation 72e11f2d-a348-4c12-9cd8-1e6f0f6f7399 2026-04-09 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen Dye-Free IBUPROFEN Wal-Mart Stores Inc 23cb5001-6aeb-434a-b2e8-aaf8bbab9dc6 2026-04-01 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 ndc (product): 49035-438 Ibuprofen Dye Free IBUPROFEN WALMART INC. 2b04d255-a1df-4698-9b5a-ad7a12205e1b 2026-03-25 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 pain relief ibuprofen IBUPROFEN Rite Aid Corporation 2bd1438e-27b1-81ff-f8e1-0f5b50b04581 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN H E B 88c7486b-f9a7-4856-a25a-7c06e1382f1a 2026-02-02 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 82e907e6-86a9-5c7f-93bd-a6319d74100f 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. 8ebe3e16-b7ae-d333-6671-5bc935e25900 2026-01-13 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN L.N.K. International, Inc. c93da67f-f42e-4baa-976b-73c71ba6dd71 2026-01-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Major Pharmaceuticals 6a5ad1cd-e6a3-44ad-b9b8-ff9b66f390f6 2025-12-17 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Dye Free Ibuprofen IBUPROFEN Walgreen Company d3d093f9-207a-40d4-a7be-c6b5a544a0a7 2025-12-12 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Family Dollar Services Inc 89ed9311-2185-4660-b219-9ea67b1a71ec 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139 Ibuprofen IBUPROFEN Topco Associates, LLC bcf7d4c1-1f99-48df-8f74-9abeefa8d41d 2025-11-15 Warnings Exact identifier application applno (ANDA): 075139 application number: ANDA075139
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 49035-438-12 49035043812 1 BOTTLE in 1 CARTON (49035-438-12) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2004-03-11 2021-05-16 No No Current 49035-438-90 49035043890 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (49035-438-90) 2004-03-11 2028-02-29 No No Current