Home NDC 0573-0191 INFANTS ADVIL
Product NDC 0573-0191
11-digit product format 005730191
Labeler code 0573
Product ID 0573-0191_9f156faa-6bf8-483c-837d-050e40ec0cc5
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form SUSPENSION/ DROPS
Route ORAL
Labeler Haleon US Holdings LLC
Application NDA020812
Marketing category NDA
Marketing start 1998-01-30
Substance IBUPROFEN
Active strength 50 mg/1.25mL
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020812-001 PEDIATRIC ADVIL IBUPROFEN 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 N020812-002 INFANT'S ADVIL IBUPROFEN 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12
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 3 · 81 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 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020812-001 PEDIATRIC ADVIL 100MG/2.5ML SUSPENSION/DROPS / ORAL RLD 1998-01-30 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N020812-002 INFANT'S ADVIL 50MG/1.25ML SUSPENSION/DROPS / ORAL RLD, RS 2000-01-12 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base INFANTS ADVIL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBUPROFEN 50 mg/1.25mL
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204442 Internal RxNorm lookup 731531 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 0573-0191-20 INFANTS ADVIL 15 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 15 19 0573-0191-20 INFANTS ADVIL 1 in 1 CARTON SUSPENSION/ DROPS 1 19 0573-0191-22 INFANTS ADVIL 15 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 15 19 0573-0191-22 INFANTS ADVIL 1 in 1 CARTON SUSPENSION/ DROPS 1 19 0573-0191-50 INFANTS ADVIL 1 in 1 CARTON SUSPENSION/ DROPS 1 19 0573-0191-50 INFANTS ADVIL 30 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 30 19 0573-0191-75 INFANTS ADVIL 22.5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 22.5 19 0573-0191-75 INFANTS ADVIL 1 in 1 CARTON SUSPENSION/ DROPS 1 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0573-0191 INFANTS ADVIL (IBUPROFEN) SUSPENSION/ DROPS [HALEON US HOLDINGS LLC] 19 Current NDC, Legacy NDC, 8 package rows 20241127_db5ed801-7a7e-3c83-0172-77f914daaa5a.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0573-0191-20 00573019120 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-20) / 15 mL in 1 BOTTLE, DROPPER 1998-01-30 0000-00-00 No No Current 0573-0191-22 00573019122 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-22) / 15 mL in 1 BOTTLE, DROPPER 2014-01-30 0000-00-00 No No Current 0573-0191-50 00573019150 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-50) / 30 mL in 1 BOTTLE, DROPPER 1998-01-30 0000-00-00 No No Current 0573-0191-75 00573019175 1 BOTTLE, DROPPER in 1 CARTON (0573-0191-75) / 22.5 mL in 1 BOTTLE, DROPPER 1998-01-30 0000-00-00 No No Current