Home NDC 69626-0085 REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE
Product NDC 69626-0085
11-digit product format 696260085
Labeler code 69626
Product ID 69626-0085_274788d7-9fec-5b62-e063-6294a90ad899
Type HUMAN OTC DRUG
Nonproprietary name SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Dosage form ENEMA
Route RECTAL
Labeler Leosons Overseas Corp
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-10-01
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 3.5; 9.5 g/59mL; g/59mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 3.5 g/59mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 9.5 g/59mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GR686LBA74 Internal UNII lookup 3980JIH2SW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 283100 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 69626-0085-7 REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE 1 in 1 CARTON ENEMA 1 3 69626-0085-7 REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE 67 mL in 1 BOTTLE, PLASTIC ENEMA 67 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69626-0085 REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [LEOSONS OVERSEAS CORP] 3 Current NDC, Legacy NDC, 2 package rows 20241121_90e7c2b4-35e1-4a27-afea-9257c480e190.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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM in 118 ML Enema PSN 90e7c2b4-35e1-4a27-afea-9257c480e190 3 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD 90e7c2b4-35e1-4a27-afea-9257c480e190 3 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY 90e7c2b4-35e1-4a27-afea-9257c480e190 3 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY 90e7c2b4-35e1-4a27-afea-9257c480e190 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69626-0085-7 69626008507 1 BOTTLE, PLASTIC in 1 CARTON (69626-0085-7) / 67 mL in 1 BOTTLE, PLASTIC 2019-10-01 0000-00-00 No No Current