Home NDC 55315-301 FREDS SALINE TWIN PACK
Product NDC 55315-301
11-digit product format 553150301
Labeler code 55315
Product ID 55315-301_a3afd43d-bf5f-4044-9952-243aac1251fa
Type HUMAN OTC DRUG
Nonproprietary name SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM and SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Dosage form ENEMA
Route RECTAL
Labeler FRED'S
Application part334
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2019-12-20
Substance SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM; SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
Active strength 7; 19 g/133mL; g/133mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base FREDS SALINE TWIN PACK
Brand name suffix LAXATIVE
Listing expiration 2026-12-31 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 55315-301-01 FREDS SALINE TWIN PACK LAXATIVE 133 mL in 1 BOTTLE, PLASTIC ENEMA 133 1 55315-301-01 FREDS SALINE TWIN PACK LAXATIVE 2 in 1 CARTON ENEMA 2 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55315-301 FREDS SALINE TWIN PACK LAXATIVE (SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM) ENEMA [FRED'S] 1 Current NDC, Legacy NDC, 2 package rows 20191220_7d15057f-eb3b-477f-ab14-68c3c38ea910.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 7d15057f-eb3b-477f-ab14-68c3c38ea910 1 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD 7d15057f-eb3b-477f-ab14-68c3c38ea910 1 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY 7d15057f-eb3b-477f-ab14-68c3c38ea910 1 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY 7d15057f-eb3b-477f-ab14-68c3c38ea910 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55315-301-01 55315030101 2 BOTTLE, PLASTIC in 1 CARTON (55315-301-01) / 133 mL in 1 BOTTLE, PLASTIC 2019-12-20 0000-00-00 No No Current