FDA.reportPublic FDA data

signature care clearlax

Product NDC
21130-847
11-digit product format
211300847
Labeler code
21130
Product ID
21130-847_b877c915-fe23-481a-bc42-67d9419127f8
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Safeway
Application
ANDA090685
Marketing category
ANDA
Marketing start
2015-09-01
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
signature care 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
21130-847-01signature care clearlax119 g in 1 BOTTLEPOWDER, FOR SOLUTION1197
21130-847-02signature care clearlax238 g in 1 BOTTLEPOWDER, FOR SOLUTION2387
21130-847-03signature care clearlax510 g in 1 BOTTLEPOWDER, FOR SOLUTION5107
21130-847-09signature care clearlax765 g in 1 BOTTLEPOWDER, FOR SOLUTION7657
21130-847-52signature care clearlax10 in 1 CARTONPOWDER, FOR SOLUTION107
21130-847-52signature care clearlax17 g in 1 PACKETPOWDER, FOR SOLUTION177

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PSIGNATURE CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SAFEWAY]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PSIGNATURE CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SAFEWAY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-847SIGNATURE CARE CLEARLAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [SAFEWAY]7Current NDC, Legacy NDC, 6 package rows20230620_91d2e780-2aae-411c-b7b3-820302f0f63e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
880407ClearLax 17 GM Powder for Oral SolutionPSN91d2e780-2aae-411c-b7b3-820302f0f63e7
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSN91d2e780-2aae-411c-b7b3-820302f0f63e7
880407polyethylene glycol 3350 17000 MG Powder for Oral Solution [ClearLax]SBD91d2e780-2aae-411c-b7b3-820302f0f63e7
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCD91d2e780-2aae-411c-b7b3-820302f0f63e7
880407ClearLax 17 GM Powder for Oral SolutionSY91d2e780-2aae-411c-b7b3-820302f0f63e7
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSY91d2e780-2aae-411c-b7b3-820302f0f63e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-847-0121130084701119 g in 1 BOTTLE (21130-847-01) 119 g2015-09-040000-00-00NoNoCurrent
21130-847-0221130084702238 g in 1 BOTTLE (21130-847-02) 238 g2015-09-040000-00-00NoNoCurrent
21130-847-0321130084703510 g in 1 BOTTLE (21130-847-03) 510 g2015-09-010000-00-00NoNoCurrent
21130-847-0921130084709765 g in 1 BOTTLE (21130-847-09) 765 g2017-11-060000-00-00NoNoCurrent
21130-847-522113008475210 PACKET in 1 CARTON (21130-847-52) / 17 g in 1 PACKET10 packet2021-03-110000-00-00NoNoCurrent