Restless Leg Symptom Relief

Product NDC
57955-9970
11-digit product format
579559970
Labeler code
57955
Product ID
57955-9970_3c58b3e2-9af9-4590-b9b7-7a8469e84140
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum album, Bufo rana, Causticum, Chamomilla, Crotalus horridus, Digitalis purpurea, Lachesis mutus, Lilium tigrinum, Pulsatilla, Rhus tox, Sulphur, Tarentula hispana, Viscum album and Zincum metallicum.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-13
Substance
ARSENIC TRIOXIDE; BUFO BUFO CUTANEOUS GLAND; CAUSTICUM; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; LACHESIS MUTA VENOM; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOSA TARANTULA; MATRICARIA CHAMOMILLA WHOLE; PULSATILLA VULGARIS WHOLE; SULFUR; TOXICODENDRON PUBESCENS LEAF; VISCUM ALBUM FRUITING TOP; ZINC
Active strength
10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restless Leg Symptom Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE10 [hp_X]/59mL
BUFO BUFO CUTANEOUS GLAND10 [hp_X]/59mL
CAUSTICUM10 [hp_X]/59mL
MATRICARIA CHAMOMILLA WHOLE10 [hp_X]/59mL
CROTALUS HORRIDUS HORRIDUS VENOM10 [hp_X]/59mL
DIGITALIS10 [hp_X]/59mL
LACHESIS MUTA VENOM10 [hp_X]/59mL
LILIUM LANCIFOLIUM WHOLE FLOWERING10 [hp_X]/59mL
PULSATILLA VULGARIS WHOLE10 [hp_X]/59mL
TOXICODENDRON PUBESCENS LEAF10 [hp_X]/59mL
SULFUR10 [hp_X]/59mL
LYCOSA TARANTULA10 [hp_X]/59mL
VISCUM ALBUM FRUITING TOP10 [hp_X]/59mL
ZINC10 [hp_X]/59mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
Q59QU6N72QInternal UNII lookup
DD5FO1WKFUInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
YHA2XLJ956Internal UNII lookup
F1T8QT9U8BInternal UNII lookup
VSW71SS07IInternal UNII lookup
X67Z2963PIInternal UNII lookup
I76KB35JEVInternal UNII lookup
6IO182RP7AInternal UNII lookup
70FD1KFU70Internal UNII lookup
86M454L2TTInternal UNII lookup
BK9092J5MPInternal UNII lookup
J41CSQ7QDSInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
07ab09eb-9430-4ea2-90c0-db2ca237cc96Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-9970-2Restless Leg Symptom Relief59 mL in 1 BOTTLE, SPRAYLIQUID591

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
ndc (product): 57955-9970

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57955-9970-25795599700259 mL in 1 BOTTLE, SPRAY (57955-9970-2) 59 ml2026-03-13NoNoCurrent