FDA.reportPublic FDA data

PMS Relief

Product NDC
43742-1342
11-digit product format
437421342
Labeler code
43742
Product ID
43742-1342_e3ca505b-7cf3-405a-a44e-9ad18472a141
Type
HUMAN OTC DRUG
Nonproprietary name
Agnus Castus, Cimicifuga Racemosa, Kali Carbonicum, Lycopodium Clavatum, Saccharum Officinale, Thyroidinum (Bovine), Hypothalamus Suis, Aristolochia Clematitis, Folliculinum, Aurum Sulphuratum, Candida Albicans, Cocculus Indicus, Conium Maculatum, Cyclamen Europaeum, Elaps Corallinus, Lac Caninum, Lachesis Mutus, Magnesia Carbonica, Pulsatilla (Pratensis), Stannum Metallicum
Dosage form
LIQUID
Route
ORAL
Labeler
Deseret Biologicals, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2018-07-10
Marketing end
2028-12-08
Substance
ANAMIRTA COCCULUS SEED; ARISTOLOCHIA CLEMATITIS ROOT; BLACK COHOSH; CANDIDA ALBICANS; CANIS LUPUS FAMILIARIS MILK; CHASTE TREE FRUIT; CONIUM MACULATUM FLOWERING TOP; CYCLAMEN PURPURASCENS TUBER; ESTRONE; GOLD MONOSULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; MICRURUS CORALLINUS VENOM; POTASSIUM CARBONATE; PULSATILLA PRATENSIS WHOLE; SUCROSE; SUS SCROFA HYPOTHALAMUS; THYROID, BOVINE; TIN
Active strength
12; 9; 6; 12; 12; 6; 12; 12; 10; 12; 12; 6; 12; 12; 6; 12; 6; 8; 6; 12 [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
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PMS Relief

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHASTE TREE FRUIT12 [hp_X]/mL
BLACK COHOSH9 [hp_X]/mL
POTASSIUM CARBONATE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE12 [hp_X]/mL
SUCROSE12 [hp_X]/mL
THYROID, BOVINE6 [hp_X]/mL
SUS SCROFA HYPOTHALAMUS12 [hp_X]/mL
ARISTOLOCHIA CLEMATITIS ROOT12 [hp_X]/mL
ESTRONE10 [hp_X]/mL
GOLD MONOSULFIDE12 [hp_X]/mL
CANDIDA ALBICANS12 [hp_X]/mL
ANAMIRTA COCCULUS SEED6 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP12 [hp_X]/mL
CYCLAMEN PURPURASCENS TUBER12 [hp_X]/mL
MICRURUS CORALLINUS VENOM6 [hp_X]/mL
CANIS LUPUS FAMILIARIS MILK12 [hp_X]/mL
LACHESIS MUTA VENOM6 [hp_X]/mL
MAGNESIUM CARBONATE8 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE6 [hp_X]/mL
TIN12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 20 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
433OSF3U8AInternal UNII lookup
K73E24S6X9Internal UNII lookup
BQN1B9B9HAInternal UNII lookup
C88X29Y479Internal UNII lookup
C151H8M554Internal UNII lookup
MN18OTN73WInternal UNII lookup
N6R0856Z79Internal UNII lookup
ZY0NX0W00DInternal UNII lookup
2DI9HA706AInternal UNII lookup
03VC3O9F7WInternal UNII lookup
4D7G21HDBCInternal UNII lookup
810258W28UInternal UNII lookup
Q28R5GF371Internal UNII lookup
G728143D8QInternal UNII lookup
V0S6H36980Internal UNII lookup
G39P120JQTInternal UNII lookup
VSW71SS07IInternal UNII lookup
0E53J927NAInternal UNII lookup
8E272251DIInternal UNII lookup
387GMG9FH5Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca073beb-330d-406c-9bf5-196a89f3ab58Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43742-1342-1PMS Relief30 mL in 1 BOTTLE, DROPPERLIQUID309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43742-1342PMS RELIEF (AGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUM) LIQUID [DESERET BIOLOGICALS, INC.]9Current NDC, Legacy NDC, 1 package rows20240913_ca073beb-330d-406c-9bf5-196a89f3ab58.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
PMS ReliefAGNUS CASTUS, CIMICIFUGA RACEMOSA, KALI CARBONICUM, LYCOPODIUM CLAVATUM, SACCHARUM OFFICINALE, THYROIDINUM (BOVINE), HYPOTHALAMUS SUIS, ARISTOLOCHIA CLEMATITIS, FOLLICULINUM, AURUM SULPHURATUM, CANDIDA ALBICANS, COCCULUS INDICUS, CONIUM MACULATUM, CYCLAMEN EUROPAEUM, ELAPS CORALLINUS, LAC CANINUM, LACHESIS MUTUS, MAGNESIA CARBONICA, PULSATILLA (PRATENSIS), STANNUM METALLICUMDeseret Biologicals, Inc.ca073beb-330d-406c-9bf5-196a89f3ab582024-09-11WarningsExact identifier
ndc (product): 43742-1342

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43742-1342-14374213420130 mL in 1 BOTTLE, DROPPER (43742-1342-1) 30 ml2018-07-102028-12-08NoNoCurrent