Home NDC 72288-499 basic care clearlax
Product NDC 72288-499
11-digit product format 722880499
Labeler code 72288
Product ID 72288-499_2f25aa1d-686e-4b52-b5d7-11ff68aa7fc2
Type HUMAN OTC DRUG
Nonproprietary name Polyethylene Glycol 3350
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Amazon.com Services LLC
Application ANDA090685
Marketing category ANDA
Marketing start 2020-06-22
Substance POLYETHYLENE GLYCOL 3350
Active strength 17 g/17g
Pharmacologic classes Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Orange Book products# Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090685-001 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/PACKET FOR SOLUTION / ORAL 2009-10-06 A090685-002 POLYETHYLENE GLYCOL 3350 POLYETHYLENE GLYCOL 3350 17GM/SCOOPFUL FOR SOLUTION / ORAL 2009-10-06
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Allergy alert: Do not use if you are allergic to polyethylene glycol Do not use if you have kidney disease, except under the advice and supervision of a doctor Ask a doctor before use if you have • nausea, vomiting or abdominal pain • a sudden change in bowel habits that lasts over 2 weeks • irritable bowel syndrome Ask a doctor or pharmacist before use if you are taking a prescription drug When using this product you may have loose, watery, more frequent stools Stop use and ask a doctor if • you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. • you get diarrhea • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Additional Listing Data#
Finished product Yes
Brand name base basic care clearlax
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 3350 17 g/17g
Harmonized Identifiers# Field, Values table Field Values Unii G2M7P15E5P Rxcui 876193, 880407
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72288-499-02 basic care clearlax 238 g in 1 BOTTLE POWDER, FOR SOLUTION 238 6 72288-499-03 basic care clearlax 510 g in 1 BOTTLE POWDER, FOR SOLUTION 510 6 72288-499-09 basic care clearlax 765 g in 1 BOTTLE POWDER, FOR SOLUTION 765 6 72288-499-52 basic care clearlax 17 g in 1 POUCH POWDER, FOR SOLUTION 17 6 72288-499-52 basic care clearlax 10 in 1 CARTON POWDER, FOR SOLUTION 10 6 72288-499-78 basic care clearlax 17 g in 1 POUCH POWDER, FOR SOLUTION 17 6 72288-499-78 basic care clearlax 100 in 1 CARTON POWDER, FOR SOLUTION 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72288-499 BASIC CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [AMAZON.COM SERVICES LLC] 6 Current NDC, Legacy NDC, 7 package rows 20230219_1ccb8604-34f6-4e1e-beed-eb81d6aa7aef.zip
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 72288-499-02 72288049902 238 g in 1 BOTTLE (72288-499-02) 238 g 2021-03-16 0000-00-00 No No Current 72288-499-03 72288049903 510 g in 1 BOTTLE (72288-499-03) 510 g 2020-08-26 0000-00-00 No No Current 72288-499-09 72288049909 765 g in 1 BOTTLE (72288-499-09) 765 g 2020-06-22 0000-00-00 No No Current 72288-499-52 72288049952 10 POUCH in 1 CARTON (72288-499-52) / 17 g in 1 POUCH 10 pouch 2020-10-19 0000-00-00 No No Current 72288-499-78 72288049978 100 POUCH in 1 CARTON (72288-499-78) / 17 g in 1 POUCH 100 pouch 2022-05-27 No No Current