FDA.reportPublic FDA data

Restful Legs

Product NDC
54973-3162
11-digit product format
549733162
Labeler code
54973
Product ID
54973-3162_2d7ba1f8-552a-44b8-e063-6294a90a0b7b
Type
HUMAN OTC DRUG
Nonproprietary name
arsenic trioxide, lycopodium clavatum spore, pulsatilla vulgaris, toxicodendron pubescens leaf, sulfur, and zinc
Dosage form
TABLET, SOLUBLE
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-07-17
Substance
ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; SULFUR; TOXICODENDRON PUBESCENS LEAF; ZINC
Active strength
12; 6; 6; 6; 6; 12 [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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Restful Legs
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/1
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/1
PULSATILLA VULGARIS6 [hp_X]/1
SULFUR6 [hp_X]/1
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/1
ZINC12 [hp_X]/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiS7V92P67HO, C88X29Y479, I76KB35JEV, 70FD1KFU70, 6IO182RP7A, J41CSQ7QDS

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3162-12022-11-07C16284748780-1e4f33bdf-a678-d8a0-e053-dadaa90a6e4eRestful Legs
54973-3162-22022-11-07C16284748780-1e4f33bdf-a678-d8a0-e053-dadaa90a6e4eRestful Legs
54973-3162-12022-07-29C16284748780-1e4f33bdf-a678-d8a0-e053-dadaa90a6e4eRestful Legs
54973-3162-22022-07-29C16284748780-1e4f33bdf-a678-d8a0-e053-dadaa90a6e4eRestful Legs

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3162-1Restful Legs1 in 1 CARTONTABLET, SOLUBLE19
54973-3162-1Restful Legs50 in 1 BOTTLE, PLASTICTABLET, SOLUBLE509
54973-3162-2Restful Legs4 in 1 PACKETTABLET, SOLUBLE49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3162-1EA - Each54973-3162a0a89851-6903-40fc-bf53-8e57eb20f66212023-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HORESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEVRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
SULFURACTIVE INGREDIENT70FD1KFU70RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ARESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
ZINCACTIVE INGREDIENTJ41CSQ7QDSRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AVRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEVRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
SULFURACTIVE MOIETY70FD1KFU70RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ARESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
ZINCACTIVE MOIETYJ41CSQ7QDSRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GRESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3162RESTFUL LEGS (ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, AND ZINC) TABLET, SOLUBLE [HYLAND'S INC.]9Current NDC, Legacy NDC, 3 package rows20250209_36e5843c-916a-425c-becc-15674cda7a65.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3162-1549733162011 BOTTLE, PLASTIC in 1 CARTON (54973-3162-1) / 50 TABLET, SOLUBLE in 1 BOTTLE, PLASTIC2006-07-170000-00-00NoNoCurrent
54973-3162-2549733162024 TABLET, SOLUBLE in 1 PACKET (54973-3162-2) 2006-07-170000-00-00NoNoCurrent