Home NDC 61245-084 Direct Safety Ibuprofen
Product NDC 61245-084
11-digit product format 612450084
Labeler code 61245
Product ID 61245-084_3e5d726a-c5b3-989b-e063-6394a90aeb7d
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form TABLET, COATED
Route ORAL
Labeler Conney Safety Products, LLC
Application ANDA079174
Marketing category ANDA
Marketing start 2014-11-17
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 43 .
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 A079174-001 IBUPROFEN IBUPROFEN 200MG TABLET / ORAL 2010-12-10
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 · 43 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 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A079174-001 IBUPROFEN 200MG TABLET / ORAL 2010-12-10 f41ea6bd6efb…
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 Direct Safety Ibuprofen
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 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 61245-084-13 Direct Safety Ibuprofen 250 in 1 BOX TABLET, COATED 250 9 61245-084-13 Direct Safety Ibuprofen 2 in 1 PACKET TABLET, COATED 2 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61245-084 DIRECT SAFETY IBUPROFEN (IBUPROFEN) TABLET, COATED [CONNEY SAFETY PRODUCTS, LLC] 8 Current NDC, Legacy NDC, 2 package rows 20240117_07afce34-aaea-50a1-e054-00144ff88e88.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 4 · 70 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 61245-084-13 61245008413 250 PACKET in 1 BOX (61245-084-13) / 2 TABLET, COATED in 1 PACKET 250 packet 2014-11-17 0000-00-00 No No Current