Home NDC 36800-057 Topcare Infants Ibuprofen
Product NDC 36800-057
11-digit product format 368000057
Labeler code 36800
Product ID 36800-057_f581be63-9628-433f-8a31-eba6f530254e
Type HUMAN OTC DRUG
Nonproprietary name ibuprofen
Dosage form SUSPENSION
Route ORAL
Labeler Topco Associates LLC
Application ANDA075217
Marketing category ANDA
Marketing start 2002-01-22
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075217-001 IBUPROFEN IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16
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 A075217-001 IBUPROFEN 40MG/ML SUSPENSION/DROPS / ORAL 1998-12-16 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 2 · 30 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Topcare Infants Ibuprofen
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204442 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 36800-057-05 Topcare Infants Ibuprofen 15 mL in 1 BOTTLE SUSPENSION 15 7 36800-057-05 Topcare Infants Ibuprofen 1 in 1 CARTON SUSPENSION 1 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-057 TOPCARE INFANTS IBUPROFEN (IBUPROFEN) SUSPENSION [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 2 package rows 20250505_00d33273-e8c7-4d40-8e6f-a980f746fff2.zip
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 36800-057-05 36800005705 1 BOTTLE in 1 CARTON (36800-057-05) / 15 mL in 1 BOTTLE 1 bottle 2002-01-22 0000-00-00 No No Current