Arthritis

Product NDC
44911-0538
11-digit product format
449110538
Labeler code
44911
Product ID
44911-0538_458b9734-bde4-40b9-8742-4bceccaf6efe
Type
HUMAN OTC DRUG
Nonproprietary name
Apis Mellifica, Bryonia (Alba), Causticum, Colchicum Autumnale, Kali Carbonicum, Kalmia Latifolia, Ledum Palustre, Pulsatilla (Pratensis), Rhododendron Chrysanthum, Rhus Tox
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-03-25
Marketing end
2025-04-16
Substance
ANEMONE PRATENSIS; APIS MELLIFERA; BRYONIA ALBA ROOT; CAUSTICUM; COLCHICUM AUTUMNALE BULB; KALMIA LATIFOLIA LEAF; LEDUM PALUSTRE TWIG; POTASSIUM CARBONATE; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF
Active strength
30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct44911-0538DDiscontinued by firm2026-10-12
excluded packagepackage44911-053844911-0538-1DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage44911-0538-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage44911-0538-1f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0538-12022-03-23C16284748780-1d6a99b39-bc85-a426-e053-dadaa90af4c2Drug Facts:
44911-0538-12022-01-28C16284748780-1d6a99b39-bc85-a426-e053-dadaa90af4c2Drug Facts:

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0538-14491105380130 mL in 1 BOTTLE, DROPPER (44911-0538-1) 30 ml2020-03-252025-04-16NoNoCurrent