Home NDC 0904-5309 Ibuprofen
Product NDC 0904-5309
11-digit product format 009045309
Labeler code 0904
Product ID 0904-5309_d07b6a1b-1390-466f-8cfd-95e809f8044c
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Major Pharmaceuticals
Application ANDA074937
Marketing category ANDA
Marketing start 1999-02-07
Substance IBUPROFEN
Active strength 100 mg/5mL
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 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 A074937-001 CHILDREN'S IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22
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 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 cb3db0bc1861…
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/5mL
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 197803 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 0904-5309-09 Ibuprofen 240 mL in 1 BOTTLE SUSPENSION 240 9 0904-5309-09 Ibuprofen 1 in 1 CARTON SUSPENSION 1 9 0904-5309-20 Ibuprofen 120 mL in 1 BOTTLE SUSPENSION 120 9 0904-5309-20 Ibuprofen 1 in 1 CARTON SUSPENSION 1 9
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 4 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [ATLANTIC BIOLOGICALS CORPS] 3 IBUPROFEN ACTIVE INGREDIENT WK2XYI10QM IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Ibuprofen ACTIVE INGREDIENT WK2XYI10QM CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 IBUPROFEN ACTIVE MOIETY WK2XYI10QM IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Ibuprofen ACTIVE MOIETY WK2XYI10QM CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 BUTYLPARABEN INACTIVE INGREDIENT 3QPI1U3FV8 IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 D&C Yellow No. 10 INACTIVE INGREDIENT 35SW5USQ3G CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 HIGH FRUCTOSE CORN SYRUP INACTIVE INGREDIENT XY6UN3QB6S IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Sucrose INACTIVE INGREDIENT C151H8M554 CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE IBUPROFEN SUSPENSION [H.J. HARKINS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-5309 IBUPROFEN SUSPENSION [MAJOR PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 4 package rows 20250305_847758ed-66fc-4db9-8fdb-78f3c3291a03.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 5 · 82 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 0904-5309-09 00904530909 1 BOTTLE in 1 CARTON (0904-5309-09) / 240 mL in 1 BOTTLE 1 bottle 2003-12-09 0000-00-00 No No Current 0904-5309-20 00904530920 1 BOTTLE in 1 CARTON (0904-5309-20) / 120 mL in 1 BOTTLE 1 bottle 1999-02-07 0000-00-00 No No Current