Home NDC 52412-910 Pediacare Childrens Ibuprofen Berry
Product NDC 52412-910
11-digit product format 524120910
Labeler code 52412
Product ID 52412-910_3cd2cd8d-d5cd-4eaf-9e60-980a7f62a3b8
Type HUMAN OTC DRUG
Nonproprietary name IBUPROFEN
Dosage form SUSPENSION
Route ORAL
Labeler RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH
Application ANDA210602
Marketing category ANDA
Marketing start 2023-01-03
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 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.
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 A210602-001 IBUPROFEN 100MG/5ML SUSPENSION / ORAL 2018-11-23 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 Pediacare Childrens Ibuprofen Berry
Listing expiration 2026-12-31 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 52412-910-04 Pediacare Childrens Ibuprofen Berry 118 mL in 1 BOTTLE SUSPENSION 118 1 52412-910-04 Pediacare Childrens Ibuprofen Berry 1 in 1 CARTON SUSPENSION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52412-910 PEDIACARE CHILDRENS IBUPROFEN BERRY (IBUPROFEN) SUSPENSION [RANDOB LABS,LTD. DBA CROSSINGWELL CONSUMER HEALTH] 1 Current NDC, Legacy NDC, 2 package rows 20230103_347d081f-068c-4173-9b4b-001ab2b891f5.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 52412-910-04 52412091004 1 BOTTLE in 1 CARTON (52412-910-04) / 118 mL in 1 BOTTLE 1 bottle 2023-01-03 0000-00-00 No No Current