FDA.reportPublic FDA data

Restless Legs

Product NDC
70163-0006
11-digit product format
701630006
Labeler code
70163
Product ID
70163-0006_a880b8f3-1069-4767-9071-a602829fb4ec
Type
HUMAN OTC DRUG
Nonproprietary name
Arsenicum Album, Causticum, Chamomilla, Lycopodium Clavatum, Palladium Metallicum, Platinum Metallicum, Zincum Metallicum
Dosage form
TABLET
Route
ORAL
Labeler
NaturalCare
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-02
Substance
ARSENIC TRIOXIDE; CAUSTICUM; LYCOPODIUM CLAVATUM SPORE; MATRICARIA CHAMOMILLA WHOLE; PALLADIUM; PLATINUM; ZINC
Active strength
12; 12; 6; 6; 12; 12; 12 [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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restless Legs
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/1
CAUSTICUM12 [hp_X]/1
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/1
MATRICARIA CHAMOMILLA WHOLE6 [hp_X]/1
PALLADIUM12 [hp_X]/1
PLATINUM12 [hp_X]/1
ZINC12 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, DD5FO1WKFU, C88X29Y479, G0R4UBI2ZZ, 5TWQ1V240M, 49DFR088MY, J41CSQ7QDS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70163-0006-1Restless Legs1 in 1 CARTONTABLET11
70163-0006-1Restless Legs60 in 1 BLISTER PACKTABLET601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70163-0006-1701630006011 BLISTER PACK in 1 CARTON (70163-0006-1) / 60 TABLET in 1 BLISTER PACK1 blister pack2026-03-02NoNoHistorical