Label: DISTRESS DROPS 2121- distress drops liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 63083-2121-2 - Packager: Professional Complementary Health Formulas
- 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 August 15, 2019
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INGREDIENTS AND APPEARANCE
DISTRESS DROPS 2121
distress drops liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63083-2121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 1 [hp_X] in 59 mL FERULA ASSA-FOETIDA RESIN (UNII: W9FZA51AS1) (FERULA ASSA-FOETIDA RESIN - UNII:W9FZA51AS1) FERULA ASSA-FOETIDA RESIN 3 [hp_X] in 59 mL DICENTRA CANADENSIS ROOT (UNII: Y5JS7YM46F) (DICENTRA CANADENSIS ROOT - UNII:Y5JS7YM46F) DICENTRA CANADENSIS ROOT 3 [hp_X] in 59 mL HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3) HYOSCYAMUS NIGER 3 [hp_X] in 59 mL FERULA SUMBUL ROOT (UNII: GLA4808EHQ) (FERULA SUMBUL ROOT - UNII:GLA4808EHQ) FERULA SUMBUL ROOT 6 [hp_X] in 59 mL VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN 3 [hp_X] in 59 mL CICUTA VIROSA WHOLE (UNII: 3E698BL84C) (CICUTA VIROSA WHOLE - UNII:3E698BL84C) CICUTA VIROSA WHOLE 4 [hp_X] in 59 mL STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED 4 [hp_X] in 59 mL GAULTHERIA PROCUMBENS TOP (UNII: 830295X963) (GAULTHERIA PROCUMBENS TOP - UNII:830295X963) GAULTHERIA PROCUMBENS TOP 4 [hp_X] in 59 mL DELPHINIUM STAPHISAGRIA SEED (UNII: 00543AP1JV) (DELPHINIUM STAPHISAGRIA SEED - UNII:00543AP1JV) DELPHINIUM STAPHISAGRIA SEED 4 [hp_X] in 59 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:63083-2121-2 59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 08/15/1985 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/15/1984 Labeler - Professional Complementary Health Formulas (167339027) Registrant - Natural Pharmaceutical Manufacturing LLC (015624923) Establishment Name Address ID/FEI Business Operations Natural Pharmaceutical Manufacturing LLC 015624923 manufacture(63083-2121)