Home NDC 55758-304 Dolex Children
Product NDC 55758-304
11-digit product format 557580304
Labeler code 55758
Product ID 55758-304_ac3c264f-da36-a474-e053-2a95a90abdad
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form LIQUID
Route ORAL
Labeler Pharmadel LLC
Application ANDA210602
Marketing category ANDA
Marketing start 2020-08-07
Substance IBUPROFEN
Active strength 100 mg/100mL
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 A210602-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23
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 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Dolex Children
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 100 mg/100mL
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 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 55758-304-04 Dolex Children 1 in 1 CARTON LIQUID 1 1 55758-304-04 Dolex Children 118 mL in 1 BOTTLE LIQUID 118 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55758-304 DOLEX CHILDREN (IBUPROFEN) LIQUID [PHARMADEL LLC] 1 Current NDC, Legacy NDC, 2 package rows 20200904_ac3c264f-da37-a474-e053-2a95a90abdad.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 · 30 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55758-304-04 55758030404 1 BOTTLE in 1 CARTON (55758-304-04) / 118 mL in 1 BOTTLE 1 bottle 2020-08-07 0000-00-00 No No Current