Flexmore PM

Product NDC
54973-3401
Requested package NDC
54973-3401-1
11-digit product format
549733401
Labeler code
54973
Product ID
54973-3401_efa4f263-df82-446e-e053-2a95a90a5194
Type
HUMAN OTC DRUG
Nonproprietary name
BRYONIA ALBA ROOT,ERROSOFERRIC PHOSPHATE,RHODODENDRON TOMENTOSUM LEAFY TWIG,COLCHICUM AUTUMNALE BULB,ANEMONE PULSATILLA,POTASSIUM PHOSPHATE, DIBASIC,KALMIA LATIFOLIA LEAF,COMFREY ROOT,TOXICODENDRON PUBESCENS LEAF and ATROPA BELLADONNA
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-01
Marketing end
0000-00-00
Substance
ANEMONE PULSATILLA; ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; FERROSOFERRIC PHOSPHATE; KALMIA LATIFOLIA LEAF; POTASSIUM PHOSPHATE, DIBASIC; RHODODENDRON TOMENTOSUM LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF
Active strength
12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage54973-340154973-3401-1DDiscontinued by firm2026-10-05

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 · 7 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…

Reported adverse events (FAERS/openFDA)#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3401-1549733401011 BOTTLE, PLASTIC in 1 CARTON (54973-3401-1) > 50 TABLET in 1 BOTTLE, PLASTIC2019-06-010000-00-00NoNoCurrent