Label: D-85- hydrangea arborescens root, saw palmetto, corn silk, elymus repens root, agathosma crenulata leaf, sodium phosphate, dibasic, heptahydrate, and dibasic potassium phosphate solution
- NDC Code(s): 58264-0091-1
- 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 June 5, 2022
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INGREDIENTS AND APPEARANCE
D-85
hydrangea arborescens root, saw palmetto, corn silk, elymus repens root, agathosma crenulata leaf, sodium phosphate, dibasic, heptahydrate, and dibasic potassium phosphate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0091 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDRANGEA ARBORESCENS ROOT (UNII: SFK828Q2DE) (HYDRANGEA ARBORESCENS ROOT - UNII:SFK828Q2DE) HYDRANGEA ARBORESCENS ROOT 1 [hp_X] in 1 mL SAW PALMETTO (UNII: J7WWH9M8QS) (SAW PALMETTO - UNII:J7WWH9M8QS) SAW PALMETTO 1 [hp_X] in 1 mL CORN SILK (UNII: 7D3VB244UX) (CORN SILK - UNII:7D3VB244UX) CORN SILK 1 [hp_X] in 1 mL ELYMUS REPENS ROOT (UNII: 3IXW0F6P8W) (ELYMUS REPENS ROOT - UNII:3IXW0F6P8W) ELYMUS REPENS ROOT 1 [hp_X] in 1 mL AGATHOSMA CRENULATA LEAF (UNII: IIV9247F0W) (AGATHOSMA CRENULATA LEAF - UNII:IIV9247F0W) AGATHOSMA CRENULATA LEAF 1 [hp_X] in 1 mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 1 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR, POTASSIUM CATION - UNII:295O53K152) DIBASIC POTASSIUM PHOSPHATE 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:58264-0091-1 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)