Home NDC 81033-019 CHILDRENS Ibuprofen
Product NDC 81033-019
11-digit product format 810330019
Labeler code 81033
Product ID 81033-019_436c00d4-44ed-b9a9-e063-6294a90a9448
Type HUMAN OTC DRUG
Nonproprietary name Ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Kesin Pharma Corporation
Application ANDA074937
Marketing category ANDA
Marketing start 2011-04-28
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 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 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.
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 2026-08-01 22:54:32 2026-06 A074937-001 CHILDREN'S IBUPROFEN 100MG/5ML SUSPENSION / ORAL 1998-12-22 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 5 · 82 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base CHILDRENS 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 81033-019-01 CHILDRENS Ibuprofen 100 in 1 CASE SUSPENSION 100 1 81033-019-02 CHILDRENS Ibuprofen 100 in 1 CASE SUSPENSION 100 1 81033-019-05 CHILDRENS Ibuprofen 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 1 81033-019-10 CHILDRENS Ibuprofen 10 mL in 1 CUP, UNIT-DOSE SUSPENSION 10 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 81033-019-01 81033001901 100 CUP, UNIT-DOSE in 1 CASE (81033-019-01) / 5 mL in 1 CUP, UNIT-DOSE (81033-019-05) 2025-11-01 No No Current 81033-019-02 81033001902 100 CUP, UNIT-DOSE in 1 CASE (81033-019-02) / 10 mL in 1 CUP, UNIT-DOSE (81033-019-10) 2025-11-01 No No Current 81033-019-05 81033001905 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 81033-019-10 81033001910 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical