Home NDC 53329-014 Pure and Gentle Laxative
Product NDC 53329-014
11-digit product format 533290014
Labeler code 53329
Product ID 53329-014_27d44bbd-bd6d-844e-e063-6394a90a6273
Type HUMAN OTC DRUG
Nonproprietary name sodium phosphate
Dosage form ENEMA
Route RECTAL
Labeler Medline Industries, LP
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-09
Substance SODIUM PHOSPHATE, DIBASIC; SODIUM PHOSPHATE, MONOBASIC
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 Pure and Gentle Laxative
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, DIBASIC 7 g/118mL SODIUM PHOSPHATE, MONOBASIC 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 53329-014-11 Pure and Gentle Laxative 1 in 1 BOX ENEMA 1 13 53329-014-11 Pure and Gentle Laxative 133 mL in 1 BOTTLE ENEMA 133 13 53329-014-58 Pure and Gentle Laxative 133 mL in 1 BOTTLE ENEMA 133 13 53329-014-58 Pure and Gentle Laxative 24 in 1 CASE ENEMA 24 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SODIUM PHOSPHATE, DIBASIC ACTIVE INGREDIENT GR686LBA74 PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3 SODIUM PHOSPHATE, MONOBASIC ACTIVE INGREDIENT 3980JIH2SW PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-014 PURE AND GENTLE LAXATIVE (SODIUM PHOSPHATE) ENEMA [MEDLINE INDUSTRIES, LP] 13 Current NDC, Legacy NDC, 4 package rows 20241127_e3165538-75dd-4f0f-adc8-d4075de10f1e.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 e3165538-75dd-4f0f-adc8-d4075de10f1e 13 283100 sodium phosphate, dibasic 59.3 MG/ML / sodium phosphate, monobasic 161 MG/ML Enema SCD e3165538-75dd-4f0f-adc8-d4075de10f1e 13 283100 sodium phosphate, dibasic 3.5 GM / sodium phosphate, monobasic 9.5 GM per 59 ML Enema SY e3165538-75dd-4f0f-adc8-d4075de10f1e 13 283100 sodium phosphate, dibasic 7 GM / sodium phosphate, monobasic 19 GM per 118 ML Enema SY e3165538-75dd-4f0f-adc8-d4075de10f1e 13
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-014-11 53329001411 1 BOTTLE in 1 BOX (53329-014-11) / 133 mL in 1 BOTTLE 1 bottle 2017-11-10 0000-00-00 No No Current 53329-014-58 53329001458 24 BOTTLE in 1 CASE (53329-014-58) / 133 mL in 1 BOTTLE 24 bottle 2017-11-03 0000-00-00 No No Current