FLEXMORE

Product NDC
54973-3397
Requested package NDC
54973-3397-2
11-digit product format
549733397
Labeler code
54973
Product ID
54973-3397_eb95bb71-9607-1885-e053-2995a90a9eda
Type
HUMAN OTC DRUG
Nonproprietary name
Atropa Belladonna, Bryonia Alba Root, Colchicum Autumnale Bulb, Guaiacum Officinale Resin, Kalmia Latifolia Leaf, Rhododendron Tomentosum Leafy Twig, Ruta Graveolens Flowering Top, Tribasic Calcium Phosphate, Comfrey Root and Toxicodendron Pubescens Leaf
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-06-01
Marketing end
0000-00-00
Substance
ATROPA BELLADONNA; BRYONIA ALBA ROOT; COLCHICUM AUTUMNALE BULB; COMFREY ROOT; GUAIACUM OFFICINALE RESIN; KALMIA LATIFOLIA LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF; TRIBASIC CALCIUM PHOSPHATE
Active strength
30 [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
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 packagepackage54973-339754973-3397-2DDiscontinued 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54973-3397-2549733397024 TABLET in 1 PACKET (54973-3397-2) 4 tablet2019-06-010000-00-00YesNoCurrent