Home NDC 71443-001 QUALITY CHOICE SINGLE SALINE
Product NDC 71443-001
11-digit product format 714430001
Labeler code 71443
Product ID 71443-001_987aa9cc-4f7e-442b-b901-a60597a5ad32
Type HUMAN OTC DRUG
Nonproprietary name SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Dosage form ENEMA
Route RECTAL
Labeler Alcyon Health, LLC.
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-07-05
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 7; 19 g/118mL; g/118mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base QUALITY CHOICE SINGLE SALINE
Brand name suffix LAXATIVE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM 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 71443-001-06 QUALITY CHOICE SINGLE SALINE LAXATIVE 6 in 1 CARTON ENEMA 6 1 71443-001-06 QUALITY CHOICE SINGLE SALINE LAXATIVE 133 mL in 1 BOTTLE ENEMA 133 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71443-001 QUALITY CHOICE SINGLE SALINE LAXATIVE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [ALCYON HEALTH, LLC.] 1 Current NDC, Legacy NDC, 2 package rows 20170729_eb499c7f-9c7b-4097-83a3-82aabffd6beb.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 eb499c7f-9c7b-4097-83a3-82aabffd6beb 1 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD eb499c7f-9c7b-4097-83a3-82aabffd6beb 1 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY eb499c7f-9c7b-4097-83a3-82aabffd6beb 1 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY eb499c7f-9c7b-4097-83a3-82aabffd6beb 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 71443-001-06 71443000106 6 BOTTLE in 1 CARTON (71443-001-06) / 133 mL in 1 BOTTLE 6 bottle 2017-07-05 0000-00-00 No No Current