Asutra WellHeal

Product NDC
58368-010
Requested package NDC
58368-010-01
11-digit product format
583680010
Labeler code
58368
Product ID
58368-010_edab5539-0946-7e7b-e053-2a95a90a7ff9
Type
HUMAN OTC DRUG
Nonproprietary name
Salix Alba Bark, Stellaria Media, Comfrey Root, Horse Chestnut, Daphne Mezereum Bark, Equisetum Arvense Top, Urtica Urens, Althaea Officinalis Root, Hamamelis Virginiana Root Bark/Stem Bark, Calendula Officinalis Flowering Top
Dosage form
CREAM
Route
TOPICAL
Labeler
BioLyte Laboratories, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-08-07
Marketing end
0000-00-00
Substance
ALTHAEA OFFICINALIS ROOT; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; DAPHNE MEZEREUM BARK; EQUISETUM ARVENSE TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HORSE CHESTNUT; SALIX ALBA BARK; STELLARIA MEDIA; URTICA URENS
Active strength
2 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
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 packagepackage58368-01058368-010-01DDiscontinued 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 · 12 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…

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
58368-010-01583680010011 BOTTLE, PUMP in 1 CARTON (58368-010-01) > 28 g in 1 BOTTLE, PUMP2020-08-070000-00-00NoNoCurrent