Dulcolax

Product NDC
41167-0223
11-digit product format
411670223
Labeler code
41167
Product ID
41167-0223_ac5d744b-7090-4649-97b8-352d61425b09
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene glycol 3350
Dosage form
POWDER
Route
ORAL
Labeler
Chattem, Inc.
Application
ANDA090685
Marketing category
ANDA
Marketing start
2025-09-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Dulcolax
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiG2M7P15E5P
Rxcui876193, 2724421

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
41167-0223-0Dulcolax765 g in 1 BOTTLEPOWDER7651

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2724421Dulcolax Osmotic 17 GM Powder for Oral SolutionPSNed16d0f4-74e7-4fa3-989d-c6840a5d3e711
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNed16d0f4-74e7-4fa3-989d-c6840a5d3e711
2724421polyethylene glycol 3350 17000 MG Powder for Oral Solution [Dulcolax Osmotic]SBDed16d0f4-74e7-4fa3-989d-c6840a5d3e711
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDed16d0f4-74e7-4fa3-989d-c6840a5d3e711
2724421Dulcolax Osmotic 17 GM Powder for Oral SolutionSYed16d0f4-74e7-4fa3-989d-c6840a5d3e711
2724421Dulcolax Osmotic 17000 MG Powder for Oral SolutionSYed16d0f4-74e7-4fa3-989d-c6840a5d3e711
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYed16d0f4-74e7-4fa3-989d-c6840a5d3e711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
41167-0223-041167022300765 g in 1 BOTTLE (41167-0223-0) 765 g2025-09-30NoNoCurrent