Label: D-88- cocculus indicus, natrum muriaticum, helonias dioica, calcarea phosphoricum, ignatia amara, magnesia phosphoricum, cimicifuga racemosa, passiflora incarnata, valeriana officinalis, sepia, kalium phosphoricum, zincum metallicum, pituitary, adrenal, ovarian solution
- NDC Code(s): 58264-0094-1
- 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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- SPL UNCLASSIFIED SECTION
- INDICATIONS
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INGREDIENTS
ACTIVE
Cocculus indicus 6x, Natrum muriaticum 12x, Helonias dioica 5x, Calcarea phosphoricum 12x, Ignatia amara 6x, Magnesia phosphoricum 6x, Cimicifuga racemosa 4x, Passiflora incarnata 4x, Valeriana officinalis 4x, Sepia 10x, Kalium phosphoricum 6x, Zincum metallicum 8x, Pituitary 6x, Adrenal 6x, Ovarian 6x
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- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
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INGREDIENTS AND APPEARANCE
D-88
cocculus indicus, natrum muriaticum, helonias dioica, calcarea phosphoricum, ignatia amara, magnesia phosphoricum, cimicifuga racemosa, passiflora incarnata, valeriana officinalis, sepia, kalium phosphoricum, zincum metallicum, pituitary, adrenal, ovarian solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58264-0094 Route of Administration SUBLINGUAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 12 [hp_X] in 1 mL CHAMAELIRIUM LUTEUM ROOT (UNII: DQV54Y5H3U) (CHAMAELIRIUM LUTEUM ROOT - UNII:DQV54Y5H3U) CHAMAELIRIUM LUTEUM ROOT 5 [hp_X] in 1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 12 [hp_X] in 1 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 6 [hp_X] in 1 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 6 [hp_X] in 1 mL BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH 4 [hp_X] in 1 mL PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP 4 [hp_X] in 1 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 4 [hp_X] in 1 mL SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE 10 [hp_X] in 1 mL DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) DIBASIC POTASSIUM PHOSPHATE 6 [hp_X] in 1 mL BOS TAURUS PITUITARY GLAND, POSTERIOR (UNII: 7JM57I419K) (BOS TAURUS PITUITARY GLAND, POSTERIOR - UNII:7JM57I419K) BOS TAURUS PITUITARY GLAND, POSTERIOR 6 [hp_X] in 1 mL ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 8 [hp_X] in 1 mL BOS TAURUS ADRENAL GLAND (UNII: M2776SWB29) (BOS TAURUS ADRENAL GLAND - UNII:M2776SWB29) BOS TAURUS ADRENAL GLAND 6 [hp_X] in 1 mL BOS TAURUS OVARY (UNII: 66LZN1C747) (BOS TAURUS OVARY - UNII:66LZN1C747) BOS TAURUS OVARY 6 [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:58264-0094-1 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)
