Home NDC 53329-014-11 Pure and Gentle Laxative
Product NDC 53329-014
Requested package NDC 53329-014-11
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 20 of 42 · 829 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join up and up fiber therapy PSYLLIUM HUSK TARGET CORPORATION 956c48f8-c705-4a86-9866-c68a48ddeb6c 2025-11-05 Warnings Exact identifier application number: M007 CEO-TWO LAXATIVE Beutlich Pharmaceuticals, LLC 08670636-5795-4db0-e063-6294a90afa4b 2025-11-05 Warnings Exact identifier application number: M007 up and up gentle laxative BISACODYL Target Corporation 4a29dc2b-b68f-471b-a84e-4a5096aa3748 2025-11-04 Warnings Exact identifier application number: M007 Target Fiber Laxative PSYLLIUM HUSK TARGET CORPORATION a581116a-392d-4ac3-ae15-4318506a7b2a 2025-11-04 Warnings Exact identifier application number: M007 up and up fiber therapy CALCIUM POLYCARBOPHIL Target Corporation. e5473950-06f4-4ea4-975b-3ac94957e776 2025-11-04 Warnings Exact identifier application number: M007 up and up fiber therapy Natural Fiber PSYLLIUM HUSK Target Corporation f8b1c831-6fd0-4a58-9726-4e0f986c8084 2025-11-04 Warnings Exact identifier application number: M007 OneLAX BISACODYL AKRON PHARMA INC be4eeb4d-df29-45dc-94ff-933e52c8b6f6 2025-11-03 Warnings Exact identifier application number: M007 Gentle Stool Softener DOCUSATE SODIUM WALGREEN COMPANY 169b33f9-e559-47bf-bbba-c7eda4762c7f 2025-10-31 Warnings Exact identifier application number: M007 Senna S DOCUSATE SODIUM, SENNOSIDES Walgreens 765bfd9b-7a21-4315-9add-cf13007722d5 2025-10-31 Warnings Exact identifier application number: M007 Gentle Stool Softener DOCUSATE SODIUM WALGREEN COMPANY 71b15339-2585-4fae-8445-6fbb4f0a378e 2025-10-31 Warnings Exact identifier application number: M007 Stool Softener Laxative DOCUSATE SODIUM Major Pharmaceuticals 97561cd4-63d9-44c2-a3a3-ec668a09a4ed 2025-10-31 Warnings Exact identifier application number: M007 Fiber Caplets CALCIUM POLYCARBOPHIL SAFEWAY 08e2e8b0-90b3-48d6-a72a-40688c74771a 2025-10-29 Warnings Exact identifier application number: M007 Glycerin GLYCERIN Chain Drug Marketing Association Inc. 424d91f0-ecf9-6d9b-e063-6394a90a8006 2025-10-29 Warnings Exact identifier application number: M007 Publix Laxative Maximum Strength CALCIUM SENNOSIDES PUBLIX SUPER MARKETS, INC 11112859-ef1e-4b37-9915-ba4d06a3f198 2025-10-28 Warnings Exact identifier application number: M007 Publix Stimulant Laxative BISACODYL PUBLIX SUPER MARKETS, INC 02e596a7-b8e5-4f55-9bc6-6d17e0fabda7 2025-10-28 Warnings Exact identifier application number: M007 PUBLIX PSYLLIUM HUSK PUBLIX SUPER MARKETS, INC 55f98d3f-f282-4f19-b373-0b59640d274d 2025-10-28 Warnings Exact identifier application number: M007 PUBLIX CALCIUM POLYCARBOPHIL PUBLIX SUPER MARKETS, INC 02e3f4ce-8961-425c-98a9-3b9d66709ca5 2025-10-28 Warnings Exact identifier application number: M007 Publix Women Laxative BISACODYL PUBLIX SUPER MARKETS, INC 03eeca55-f239-4a01-a900-c1943f27a834 2025-10-28 Warnings Exact identifier application number: M007 Publix Fiber Therapy Orange Smooth PSYLLIUM HUSK PUBLIX SUPER MARKETS, INC b9c54c20-cd82-4627-9217-a66834db4799 2025-10-28 Warnings Exact identifier application number: M007 Publix Fiber Therapy Sugar Free PSYLLIUM HUSK PUBLIX SUPER MARKETS, INC ed3dc80a-a243-4013-9886-b148e3e3b662 2025-10-28 Warnings Exact identifier application number: M007
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