Home NDC 0904-6320 Saline Laxative
Product NDC 0904-6320
11-digit product format 009046320
Labeler code 0904
Product ID 0904-6320_8d595efb-9d1d-48d0-8660-2e83df819c7d
Type HUMAN OTC DRUG
Nonproprietary name Saline Laxative
Dosage form ENEMA
Route RECTAL
Labeler Major Pharmaceuticals
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2013-07-11
Marketing end 2027-04-30
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 7; 19 g/133mL; g/133mL
NDC exclude flag No
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 Saline Laxative Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 7 g/133mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g/133mL
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 0904-6320-78 Saline Laxative 133 mL in 1 BOTTLE ENEMA 133 9
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-6320 SALINE LAXATIVE ENEMA [MAJOR PHARMACEUTICALS] 8 Current NDC, Legacy NDC, 1 package rows 20250101_b3758ffe-1bac-4df6-9714-5e33e9d28d90.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 17 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 b3758ffe-1bac-4df6-9714-5e33e9d28d90 9 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD b3758ffe-1bac-4df6-9714-5e33e9d28d90 9 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY b3758ffe-1bac-4df6-9714-5e33e9d28d90 9 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY b3758ffe-1bac-4df6-9714-5e33e9d28d90 9
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0904-6320-78 00904632078 133 mL in 1 BOTTLE (0904-6320-78) 133 ml 2013-07-11 2027-04-30 No No Current