FDA.reportPublic FDA data

NATURA-LAX

Product NDC
63868-002
11-digit product format
638680002
Labeler code
63868
Product ID
63868-002_ee3b0446-97a6-1d86-e053-2995a90a239d
Type
HUMAN OTC DRUG
Nonproprietary name
polyethylene glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Chain Drug Marketing Association
Application
ANDA090812
Marketing category
ANDA
Marketing start
2014-05-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63868-002DDiscontinued by firm2026-07-31
excluded packagepackage63868-00263868-002-14DDiscontinued by firm2026-07-31
excluded packagepackage63868-00263868-002-30DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090812-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A090812-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-07a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EasyLAXPOLYETHYLENE GLYCOL 3350VALU MERCHANDISERS COMPANY6597811b-6471-5afd-e053-2991aa0a07c22025-12-16WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVEPharmaceutica North America, Inc.d048111f-8144-4d51-a0c2-a967b2bce4552025-03-04WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Bryant Ranch Prepack66276671-0ccd-4c32-a697-31e679fce0e32024-02-06WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
Polyethylene Glycol 3350, NF Powder for Solution, LaxativePOLYETHYLENE GLYCOL 3350, NF POWDER FOR SOLUTION, LAXATIVELGM PHARMA SOLUTIONS, LLCd78bead5-ff19-4d45-9003-ec131f1f5a132024-01-17WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier
application applno (ANDA): 090812
application number: ANDA090812

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-002-142021-05-08C16284748780-19855e2a2-35ee-60a7-e053-dbdaa90a05bdQC PEG 489
63868-002-302021-05-08C16284748780-19855e2a2-35ee-60a7-e053-dbdaa90a05bdQC PEG 489
63868-002-142019-11-27C16284748780-19855e2a2-35ee-60a7-e053-dbdaa90a05bdQC PEG 489
63868-002-302019-11-27C16284748780-19855e2a2-35ee-60a7-e053-dbdaa90a05bdQC PEG 489

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-002-14GM - Gram63868-00247fd2de8-61a6-4f2b-8131-93673de4c27212017-04-05
63868-002-30GM - Gram63868-0028020455b-232f-46be-a451-befd3c1cc64912019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POLYETHYLENE GLYCOL 3350ACTIVE INGREDIENTG2M7P15E5PNATURA-LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1
POLYETHYLENE GLYCOL 3350ACTIVE MOIETYG2M7P15E5PNATURA-LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-002NATURA-LAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [CHAIN DRUG MARKETING ASSOCIATION]3Legacy NDC20221125_67f7c248-59d1-4202-bbca-f006b709c941.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-002-1463868000214238 g in 1 BOTTLE (63868-002-14) 238 g2020-10-010000-00-00NoNoCurrent
63868-002-3063868000230510 g in 1 BOTTLE (63868-002-30) 510 g2020-10-010000-00-00NoNoCurrent