Home NDC 51316-932-04 Childrens Ibuprofen Bubblegum Dye Free
Product NDC 51316-932
Requested package NDC 51316-932-04
11-digit product format 513160932
Labeler code 51316
Product ID 51316-932_619d852f-5907-4df5-925f-14adb7120975
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler CVS
Application ANDA210149
Marketing category ANDA
Marketing start 2026-06-16
Substance IBUPROFEN
Active strength 100 mg/5mL
Pharmacologic classes Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]
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 A210149-001 IBUPROFEN IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17
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 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A210149-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-08-17 cb3db0bc1861…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Ibuprofen Bubblegum Dye Free
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.
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 1 · 11 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Status 51316-932-04 51316093204 1 BOTTLE in 1 CARTON (51316-932-04) / 240 mL in 1 BOTTLE 1 bottle 2026-06-16 0 Current