Home NDC 53329-013 Pure and Gentle
Product NDC 53329-013
11-digit product format 533290013
Labeler code 53329
Product ID 53329-013_27d437bf-4b2b-eb33-e063-6394a90a4ef6
Type HUMAN OTC DRUG
Nonproprietary name mineral oil
Dosage form ENEMA
Route RECTAL
Labeler Medline Industries, LP
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-04-09
Substance MINERAL OIL
Active strength 100 g/100mL
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
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 100 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 205121 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-013-11 Pure and Gentle 1 in 1 BOX ENEMA 1 8 53329-013-11 Pure and Gentle 133 mL in 1 BOTTLE ENEMA 133 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-013 PURE AND GENTLE (MINERAL OIL) ENEMA [MEDLINE INDUSTRIES, LP] 8 Current NDC, Legacy NDC, 2 package rows 20241127_96d4cad5-0602-4c31-94ed-3117b4fd4a94.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 29 of 42 · 833 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE Walgreens c8ea170b-57b5-4643-ba88-4cf2ae1bf6a0 2024-12-23 Warnings Exact identifier application number: M007 Sennosides SENNOSIDES Meijer, Inc. b09a234e-962d-49fc-a72e-898547b2f099 2024-12-23 Warnings Exact identifier application number: M007 Pedia-Lax GLYCERIN C.B. Fleet Company, Inc. 4e15f6ca-a40c-485f-be3f-07c2ed7cb498 2024-12-23 Warnings Exact identifier application number: M007 Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equate SENNOSIDES Wal-Mart Stores Inc 10dc8b4d-8136-44a5-a2ce-30295866cd3b 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best Choice SENNOSIDES Valu Merchandisers Company 4b7cab4b-a610-4fb9-ac31-011975f1b29c 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG health SENNOSIDES Dolgencorp Inc. 88dc2f9b-18ca-4e21-8faa-5339f82a2a75 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare health SENNOSIDES Topco Associates f051b302-f70e-4ab6-bb69-f69b45f2642e 2024-12-23 Warnings Exact identifier application number: M007 Chocolated Laxative SENNOSIDES STIMULANT LAXATIVE C.D.M.A., Inc. e80be2b6-a0ca-4838-b956-a1debb065d57 2024-12-23 Warnings Exact identifier application number: M007 Conlax BISACODYL Bliss GVS Pharma Limited 7d25990b-6f7c-1eac-e053-2a91aa0a7022 2024-12-21 Warnings Exact identifier application number: M007 GeriCare Docusate Sodium Liquid DOCUSATE SODIUM GERI-CARE PHARMACEUTICALS, CORP e50558e1-f0c8-4b03-9109-6a273b61730d 2024-12-20 Warnings Exact identifier application number: M007 SENNA Syrup SENNOSIDES A AND B SDA Laboratories, Inc. cfc6ab2f-5376-46fc-ac58-7dedd7010006 2024-12-20 Warnings Exact identifier application number: M007 Fiber Therapy CALCIUM POLYCARBOPHIL Wal-Mart Stores, Inc. 3432a4a6-aeb1-4a72-8451-5903266931fa 2024-12-20 Warnings Exact identifier application number: M007 Fiber Laxative CALCIUM POLYCARBOPHIL UNITED NATURAL FOODS, INC. DBA UNFI f7236bbc-8ded-4e11-8cce-b0a2255e1450 2024-12-20 Warnings Exact identifier application number: M007 Fiber Caps CALCIUM POLYCARBOPHIL Guardian Drug Company 31e6b0c7-1d4a-4660-ae87-9d18e0001dcd 2024-12-19 Warnings Exact identifier application number: M007 Epsom Salts MAGNESIUM SULFATE NEW PRIDE CORP f6626023-4857-518b-e053-2a95a90a9821 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA CHERRY MAGNESIUM HYDROXIDE WALGREEN COMPANY 5fae9b56-2555-b583-e053-2991aa0a8d59 2024-12-19 Warnings Exact identifier application number: M007 MILK OF MAGNESIA MAGNESIUM HYDROXIDE WALGREEN COMPANY 5faf2ed0-dd71-17c9-e053-2a91aa0ab75a 2024-12-19 Warnings Exact identifier application number: M007 Stimulant Laxative Plus Stool Softener DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG RUGBY LABORATORIES f5afd8eb-d35d-44ab-897d-1d41c98ca138 2024-12-19 Warnings Exact identifier application number: M007 Goodsense Fiber METHYLCELLULOSE GoodSense 96ed1ba1-7f91-4912-a549-a4be2c3e0362 2024-12-19 Warnings Exact identifier application number: M007 Senexon-S DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG RUGBY LABORATORIES 2e758ff1-3083-4245-8f58-1c47b042bfdd 2024-12-19 Warnings Exact identifier application number: M007
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-013-11 53329001311 1 BOTTLE in 1 BOX (53329-013-11) / 133 mL in 1 BOTTLE 1 bottle 2014-04-09 0000-00-00 No No Current