FDA.reportPublic FDA data

LYMPHDRAINEX

Product NDC
44911-0638
Requested package NDC
44911-0638-1
11-digit product format
449110638
Labeler code
44911
Product ID
44911-0638_83ecd7ca-ca54-479b-ad0b-ae95fad46491
Type
HUMAN OTC DRUG
Nonproprietary name
Geranium Robertianum, Nasturtium Aquaticum, Teucrium Scorodonia, Apis Mellifica, Equisetum Hyemale, Fumaria Officinalis, Natrum Sulphuricum, Phytolacca Decandra, Pinus Sylvestris, Veronica Officinalis, Gentiana Lutea, Sarsaparilla (Smilax Regelii), Baryta Carbonica, Hepar Sulphuris Calcareum, Mercurius Cyanatus, Scrophularia Nodosa, Aloe, Ferrum Iodatum, Myosotis Arvensis, Aranea Diadema, Calcarea Phosphorica, Juglans Regia, Parathyroid Gland (Bovine), Thymus (Suis), Thyroidinum (Suis)
Dosage form
LIQUID
Route
ORAL
Labeler
Energique, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-06-22
Marketing end
0000-00-00
Substance
GERANIUM ROBERTIANUM WHOLE; NASTURTIUM OFFICINALE; TEUCRIUM SCORODONIA FLOWERING TOP; APIS MELLIFERA; EQUISETUM HYEMALE WHOLE; FUMARIA OFFICINALIS FLOWERING TOP; SODIUM SULFATE; PHYTOLACCA AMERICANA ROOT; PINUS SYLVESTRIS LEAFY TWIG; VERONICA OFFICINALIS FLOWERING TOP; GENTIANA LUTEA ROOT; SMILAX ORNATA ROOT; BARIUM CARBONATE; CALCIUM SULFIDE; MERCURIC CYANIDE; SCROPHULARIA NODOSA WHOLE; ALOE; FERROUS IODIDE; MYOSOTIS ARVENSIS WHOLE; ARANEUS DIADEMATUS; TRIBASIC CALCIUM PHOSPHATE; JUGLANS REGIA LEAF; BOS TAURUS PARATHYROID GLAND; SUS SCROFA THYMUS; SUS SCROFA THYROID
Active strength
3 [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; [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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 packagepackage44911-063844911-0638-1DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0638-12023-12-12C16284748780-1f386c64a-0739-0266-e053-dadaa90a7c1aDRUG FACTS:
44911-0638-12023-01-30C16284748780-1f386c64a-0739-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0638-1LYMPHDRAINEX60 mL in 1 BOTTLE, DROPPERLIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0638LYMPHDRAINEX (GERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, APIS MELLIFICA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, GENTIANA LUTEA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), THYMUS (SUIS), THYROIDINUM (SUIS)) LIQUID [ENERGIQUE, INC.]2Legacy NDC, 1 package rows20231213_7bb230c6-6322-46aa-baa6-a84ccbfbbdf8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44911-0638-14491106380160 mL in 1 BOTTLE, DROPPER (44911-0638-1) 60 ml2021-06-220000-00-00NoNoCurrent