Label: D81- passiflora incarnata whole, smilax ornata whole, phytolacca americana root, stillingia sylvatica root, trifolium pratense whole, arctium lappa whole, prunus dulcis whole, frangula purshiana bark, berberis vulgaris whole, glycyrrhiza glabra whole, and larrea divaricata whole solution
- NDC Code(s): 58264-0082-1
- Packager: DNA Labs, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 13, 2025
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INGREDIENTS AND APPEARANCE
D81
passiflora incarnata whole, smilax ornata whole, phytolacca americana root, stillingia sylvatica root, trifolium pratense whole, arctium lappa whole, prunus dulcis whole, frangula purshiana bark, berberis vulgaris whole, glycyrrhiza glabra whole, and larrea divaricata whole solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0082 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PASSIFLORA INCARNATA WHOLE (UNII: R48E2W2LMO) (PASSIFLORA INCARNATA WHOLE - UNII:R48E2W2LMO) PASSIFLORA INCARNATA WHOLE 1 [hp_X] in 1 mL SMILAX ORNATA WHOLE (UNII: SJO6NF5H81) (SMILAX ORNATA WHOLE - UNII:SJO6NF5H81) SMILAX ORNATA WHOLE 1 [hp_X] in 1 mL PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT 1 [hp_X] in 1 mL STILLINGIA SYLVATICA ROOT (UNII: QBR70R4FBK) (STILLINGIA SYLVATICA ROOT - UNII:QBR70R4FBK) STILLINGIA SYLVATICA ROOT 1 [hp_X] in 1 mL TRIFOLIUM PRATENSE WHOLE (UNII: FG30UR681Y) (TRIFOLIUM PRATENSE WHOLE - UNII:FG30UR681Y) TRIFOLIUM PRATENSE WHOLE 1 [hp_X] in 1 mL ARCTIUM LAPPA WHOLE (UNII: 73070DU1LA) (ARCTIUM LAPPA WHOLE - UNII:73070DU1LA) ARCTIUM LAPPA WHOLE 1 [hp_X] in 1 mL PRUNUS DULCIS WHOLE (UNII: X3EC86GF0Z) (PRUNUS DULCIS WHOLE - UNII:X3EC86GF0Z) PRUNUS DULCIS WHOLE 1 [hp_X] in 1 mL FRANGULA PURSHIANA BARK (UNII: 4VBP01X99F) (FRANGULA PURSHIANA BARK - UNII:4VBP01X99F) FRANGULA PURSHIANA BARK 1 [hp_X] in 1 mL BERBERIS VULGARIS WHOLE (UNII: 492B79913J) (BERBERIS VULGARIS WHOLE - UNII:492B79913J) BERBERIS VULGARIS WHOLE 1 [hp_X] in 1 mL GLYCYRRHIZA GLABRA WHOLE (UNII: M1F96IE0ZC) (GLYCYRRHIZA GLABRA WHOLE - UNII:M1F96IE0ZC) GLYCYRRHIZA GLABRA WHOLE 1 [hp_X] in 1 mL LARREA DIVARICATA WHOLE (UNII: 89VP85U2R1) (LARREA DIVARICATA WHOLE - UNII:89VP85U2R1) LARREA DIVARICATA WHOLE 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58264-0082-1 29.57 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product 01/01/1990 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/01/1990 Labeler - DNA Labs, Inc. (031784339)