Home NDC 53345-050 Ibuprofen mini
Product NDC 53345-050
11-digit product format 533450050
Labeler code 53345
Product ID 53345-050_9524bc23-2aa5-4d58-8193-a972c52f1e04
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen mini
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd
Application ANDA206568
Marketing category ANDA
Marketing start 2018-11-20
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
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206568-001 IBUPROFEN IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21
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 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206568-001 IBUPROFEN EQ 200MG FREE ACID AND POTASSIUM SALT CAPSULE / ORAL 2016-06-21 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Ibuprofen mini
Listing expiration 2026-12-31 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 310964 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 53345-050-01 Ibuprofen mini 12000 in 1 BAG CAPSULE, LIQUID FILLED 12000 1 53345-050-01 Ibuprofen mini 1 in 1 BOX CAPSULE, LIQUID FILLED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-050 IBUPROFEN MINI CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD] 1 Current NDC, Legacy NDC, 2 package rows 20190504_787cda64-c03e-462e-9590-6f04b6860610.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 3 · 45 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ibuprofen IBUPROFEN Safeway, Inc. a530d43d-e9c4-4edb-af66-c92860e46f45 2026-07-23 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN P & L Development, LLC d0301d0d-fc65-420f-87fd-a08da1584d54 2026-06-08 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN CVS Pharmacy 121b13c8-0b1a-4c48-9d57-3b53a9228d34 2026-05-22 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN CVS Pharmacy a6fc144a-6826-4bf7-8efb-8cdb896387f1 2026-05-12 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN Walgreens 6d1d131d-0741-4a75-8383-9322f4f3faab 2026-03-25 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN Safeway, Inc. 22927a12-6837-4d57-8e60-043000f2f208 2026-01-05 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd 46a9424c-fd7d-f88b-e063-6294a90abceb 2025-12-24 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Family Dollar (FAMILY WELLNESS) 3a02af7e-7e69-45a6-97d7-ddc7d92b28b3 2025-10-22 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen Minis IBUPROFEN Family Dollar (FAMILY WELLNESS) 72f933d8-cf01-4bb6-a552-e3cdb297038b 2025-10-21 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN CVS Pharmacy e241ca5f-04bd-4bc9-bd0c-ca22841c4a3c 2025-07-01 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Chain Drug Consortium, LLC f0f01b97-e52c-4077-a4c6-c59736f4c171 2025-06-30 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN P & L Development, LLC 18b79fc5-57c8-46f1-81f3-2f9e189cdbcb 2025-05-16 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN AAFES/Your Military Exchanges 773b0230-a3a3-44e0-a22b-d143796ca365 2025-05-08 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN WR Group, Inc. e9dad35a-6789-42d6-97da-521db7b16496 2025-03-24 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Care One (Retail Business Services, LLC.) a6ce7484-7a32-4985-80bc-883c31be3525 2025-03-12 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Rugby Laboratories, Inc. 05c4e6c7-bf95-4e05-b7da-7a8778de342b 2024-10-28 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN P & L Development, LLC 1f9c94a6-938a-420f-b90c-36b3791e97ad 2024-10-07 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN Sam's West, Inc 74ad11b9-8976-463d-89a3-2b9f5acd0c80 2024-04-01 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen IBUPROFEN The Kroger Co. a7789f7f-3356-463b-9fd7-2d7f7eba2799 2023-12-20 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568 Ibuprofen minis IBUPROFEN Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 2b9e71c5-9b32-4b1b-a479-e5457a1f9afd 2023-10-16 Warnings Exact identifier application applno (ANDA): 206568 application number: ANDA206568
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 53345-050-01 53345005001 1 BAG in 1 BOX (53345-050-01) / 12000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2018-11-20 0000-00-00 No No Current