Restful Legs PM

Product NDC
54973-3352
Requested package NDC
54973-3352-4
11-digit product format
549733352
Labeler code
54973
Product ID
54973-3352_58cd2939-aaf5-d50a-e063-6294a90aba67
Type
HUMAN OTC DRUG
Nonproprietary name
ANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPORE
Dosage form
TABLET
Route
ORAL
Labeler
Hyland's Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-03-14
Substance
ARSENIC TRIOXIDE; MATRICARIA CHAMOMILLA; SULFUR; ZINC; ARABICA COFFEE BEAN; LYCOPODIUM CLAVATUM SPORE; PULSATILLA PATENS WHOLE; TOXICODENDRON PUBESCENS LEAF
Active strength
12; 3; 6; 12; 3; 6; 6; 6 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARSENIC TRIOXIDE12 [hp_X]/1
MATRICARIA CHAMOMILLA3 [hp_X]/1
SULFUR6 [hp_X]/1
ZINC12 [hp_X]/1
ARABICA COFFEE BEAN3 [hp_X]/1
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/1
PULSATILLA PATENS WHOLE6 [hp_X]/1
TOXICODENDRON PUBESCENS LEAF6 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S7V92P67HOInternal UNII lookup
G0R4UBI2ZZInternal UNII lookup
70FD1KFU70Internal UNII lookup
J41CSQ7QDSInternal UNII lookup
3SW678MX72Internal UNII lookup
C88X29Y479Internal UNII lookup
4M1169RWJDInternal UNII lookup
6IO182RP7AInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67667af8-b27b-1511-e053-2991aa0a3988Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3352-1Restful Legs PM1 in 1 CARTONTABLET111
54973-3352-1Restful Legs PM50 in 1 BOTTLE, PLASTICTABLET5011
54973-3352-2Restful Legs PM4 in 1 PACKETTABLET411
54973-3352-3Restful Legs PM30 in 1 BOTTLE, PLASTICTABLET3011
54973-3352-3Restful Legs PM1 in 1 CARTONTABLET111
54973-3352-4Restful Legs PM16 in 1 BOTTLE, PLASTICTABLET1611
54973-3352-4Restful Legs PM1 in 1 CARTONTABLET111
54973-3352-5Restful Legs PM1 in 1 CARTONTABLET111
54973-3352-5Restful Legs PM16 in 1 BOTTLE, PLASTICTABLET1611

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3352-1EA - Each54973-3352bc83e5a5-7163-475f-8466-c68a59ec896c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3352RESTFUL LEGS PM (ANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPORE) TABLET [HYLAND'S INC.]11Current NDC, Legacy NDC, 9 package rows20250411_67667af8-b27b-1511-e053-2991aa0a3988.zip

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
Restful Legs PMANEMONE PATENS,MATRICARIA CHAMOMILLA,SULFUR,ZINC,TOXICODENDRON PUBESCENS LEAF,ARSENIC TRIOXIDE,ARABICA COFFEE BEAN,LYCOPODIUM CLAVATUM SPOREHyland's Inc.67667af8-b27b-1511-e053-2991aa0a39882026-08-11WarningsExact identifier
ndc (package): 54973-3352-4
ndc (product): 54973-3352
ndc11 (package): 54973335204

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54973-3352-4549733352041 BOTTLE, PLASTIC in 1 CARTON (54973-3352-4) / 16 TABLET in 1 BOTTLE, PLASTIC2018-03-140000-00-00NoNoCurrent