Home NDC 71451-001 Pro-Enema Single Saline
Product NDC 71451-001
11-digit product format 714510001
Labeler code 71451
Product ID 71451-001_dc3d1fb9-2926-43fc-b39a-2248e8ce0451
Type HUMAN OTC DRUG
Nonproprietary name Sodium Phosphate, Dibasic and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Dosage form ENEMA
Route RECTAL
Labeler Propharma Medical Supplies
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-06-06
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 7; 19 g/118mL; g/118mL
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 Pro-Enema Single Saline
Brand name suffix Laxative
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC 7 g/118mL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM 19 g/118mL
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 71451-001-01 Pro-Enema Single Saline Laxative 133 mL in 1 BOTTLE, WITH APPLICATOR ENEMA 133 1 71451-001-01 Pro-Enema Single Saline Laxative 1 in 1 CARTON ENEMA 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71451-001 PRO-ENEMA SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [PROPHARMA MEDICAL SUPPLIES] 1 Current NDC, Legacy NDC, 2 package rows 20170613_e53c5eda-21da-4aed-a592-315100167cc2.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 1 of 1 · 1 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 e53c5eda-21da-4aed-a592-315100167cc2 1 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD e53c5eda-21da-4aed-a592-315100167cc2 1 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY e53c5eda-21da-4aed-a592-315100167cc2 1 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY e53c5eda-21da-4aed-a592-315100167cc2 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 71451-001-01 71451000101 1 BOTTLE, WITH APPLICATOR in 1 CARTON (71451-001-01) / 133 mL in 1 BOTTLE, WITH APPLICATOR 2017-06-06 0000-00-00 No No Current