careone clearlax

Product NDC
72476-723
11-digit product format
724760723
Labeler code
72476
Product ID
72476-723_049e8293-55a5-4803-9de1-842d6be96d11
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Retail Business Services, LLC
Application
ANDA090685
Marketing category
ANDA
Marketing start
2024-05-16
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090685-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2009-10-06
A090685-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone clearlaxPOLYETHYLENE GLYCOL 3350Retail Business Services, LLC2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2024-05-19WarningsExact identifier

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
careone clearlax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 880407

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-723-03careone clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-723CAREONE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [RETAIL BUSINESS SERVICES, LLC]2Current NDC, 1 package rows20240522_2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2
880407ClearLax 17 GM Powder for Oral SolutionSY2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY2378b76d-dc5a-4ff1-ad48-9f3e0c31c6cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72476-723-0372476072303510 g in 1 BOTTLE (72476-723-03) 510 g2024-05-16NoNoCurrent