QC Fiber Therapy

Product NDC
63868-513
Requested package NDC
63868-513-72
11-digit product format
638680513
Labeler code
63868
Product ID
63868-513_699b0986-b366-4a04-8334-6988182cc64d
Type
HUMAN OTC DRUG
Nonproprietary name
Psyllium Husk
Dosage form
POWDER
Route
ORAL
Labeler
QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-04-18
Marketing end
0000-00-00
Substance
PSYLLIUM HUSK
Active strength
3 g/12g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63868-51363868-513-72IInactivated by FDA2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-513-30QC Fiber TherapyOrange Smooth368 g in 1 BOTTLEPOWDER3683
63868-513-72QC Fiber TherapyOrange Smooth861 g in 1 BOTTLEPOWDER8613

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-513-30GM - Gram63868-513aa7ae988-6a72-43a9-82b9-104700843b5712022-10-06
63868-513-72GM - Gram63868-5136c5bfc10-9c4e-4293-9c71-58b2f342b9f612022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-513QC FIBER THERAPY ORANGE SMOOTH (PSYLLIUM HUSK) POWDER [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]3Legacy NDC, 2 package rows20210615_b3710bf7-90fd-4ec8-8701-c57a4c5959bd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
824586psyllium 3.4 GM Powder for Oral SuspensionPSNb3710bf7-90fd-4ec8-8701-c57a4c5959bd3
824586psyllium 3400 MG Powder for Oral SuspensionSCDb3710bf7-90fd-4ec8-8701-c57a4c5959bd3
824586psyllium 3.4 GM Powder for Oral SuspensionSYb3710bf7-90fd-4ec8-8701-c57a4c5959bd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-513-7263868051372861 g in 1 BOTTLE (63868-513-72) 861 g2019-04-180000-00-00NoNoCurrent