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NDC 81183-0100-30 THE FLOWER REMEDY Peaceful Feeling 200; 5; 5; 5; 5; 5; 5 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL Details

THE FLOWER REMEDY Peaceful Feeling 200; 5; 5; 5; 5; 5; 5 [hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL

THE FLOWER REMEDY Peaceful Feeling is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by The Flower Remedy. The primary component is ACONITUM NAPELLUS WHOLE; AESCULUS HIPPOCASTANUM FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER.

Product Information

NDC	81183-0100
Product ID	81183-100_36db5700-ab76-4733-b948-5e98124fef86
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	THE FLOWER REMEDY Peaceful Feeling
Proprietary Name Suffix	n/a
Non-Proprietary Name	Impatiens glandulifera, Helianthemum nummularium, Aesculus hippocastanum, Prunus cerasifera, Mimulus guttatus, Populus tremula, Aconitum Napellus
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	ORAL
Active Ingredient Strength	200; 5; 5; 5; 5; 5; 5
Active Ingredient Units	[hp_C]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL; [hp_X]/30mL
Substance Name	ACONITUM NAPELLUS WHOLE; AESCULUS HIPPOCASTANUM FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; MIMULUS GUTTATUS FLOWERING TOP; POPULUS TREMULA FLOWERING TOP; PRUNUS CERASIFERA FLOWER
Labeler Name	The Flower Remedy
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 81183-0100-30 (81183010030)

Pricing Information	N/A
NDC Package Code	81183-100-30
Billing NDC	81183010030
Package	30 mL in 1 BOTTLE, DROPPER (81183-100-30)
Marketing Start Date	2021-04-19
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 13bf1fe0-5167-497a-9a0e-34e8f8e5230a Details

Active Ingredients:

Each 30ml bottle contains equal parts of the active ingredients:

Each 5X (HPUS) Aspen (Populus tremula), Cherry Plum (Prunus cerasifera), Impatiens (Impatiens glandulifera), Mimulus (Mimulus guttatus), Rock Rose (Helianthemum nummularium), White Chestnut (Aesculus hippocastanum). 200c (HPUS) Aconitum Napellus

Purpose:

Stress relief

USES:

For relief from occasional stress

DIRECTIONS:

Take 4 drops under the tongue or in water 4 times daily.

WARNINGS:

If pregnant or breast feeding, consult a physician before use. Consult a health care provider for children under 12. Consult a physician if symptoms persist for more than 7 days.

Keep out of reach of children.

Inactive ingredients:

water, alcohol

SPL UNCLASSIFIED SECTION

THE FLOWER REMEDY

NATURAL PRODUCTS

Homeopathic Stress Relief

Homeopathic contains 27% alcohol

*The claims for this product are based upon traditional homeopathic practice, not accepted medical practices. They have not been reviewed by the Food and Drug Administration.

Manufactured and distributed by

The Flower Remedy

2921 Carlisle Blvd NE Suite 209

Albuquerque, NM 87110

Packaging

INGREDIENTS AND APPEARANCE

THE FLOWER REMEDY PEACEFUL FEELING

impatiens glandulifera, helianthemum nummularium, aesculus hippocastanum, prunus cerasifera, mimulus guttatus, populus tremula, aconitum napellus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81183-100
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IMPATIENS GLANDULIFERA FLOWER (UNII: AJU5O1A5ZV) (IMPATIENS GLANDULIFERA FLOWER - UNII:AJU5O1A5ZV)	IMPATIENS GLANDULIFERA FLOWER	5 [hp_X] in 30 mL
HELIANTHEMUM NUMMULARIUM FLOWER (UNII: 51BRR32WPP) (HELIANTHEMUM NUMMULARIUM FLOWER - UNII:51BRR32WPP)	HELIANTHEMUM NUMMULARIUM FLOWER	5 [hp_X] in 30 mL
AESCULUS HIPPOCASTANUM FLOWER (UNII: KK0Z92II8M) (AESCULUS HIPPOCASTANUM FLOWER - UNII:KK0Z92II8M)	AESCULUS HIPPOCASTANUM FLOWER	5 [hp_X] in 30 mL
PRUNUS CERASIFERA FLOWER (UNII: 0KD7R09EAS) (PRUNUS CERASIFERA FLOWER - UNII:0KD7R09EAS)	PRUNUS CERASIFERA FLOWER	5 [hp_X] in 30 mL
MIMULUS GUTTATUS FLOWERING TOP (UNII: 192426I5JU) (MIMULUS GUTTATUS FLOWERING TOP - UNII:192426I5JU)	MIMULUS GUTTATUS FLOWERING TOP	5 [hp_X] in 30 mL
POPULUS TREMULA FLOWERING TOP (UNII: 5Q01F7TPJJ) (POPULUS TREMULA FLOWERING TOP - UNII:5Q01F7TPJJ)	POPULUS TREMULA FLOWERING TOP	5 [hp_X] in 30 mL
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS WHOLE	200 [hp_C] in 30 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81183-100-30	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	04/19/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/19/2021

Labeler - The Flower Remedy (117758477)

Name	Address	ID/FEI	Business Operations
Establishment
The Flower Remedy		117758477	manufacture(81183-100)

Revised: 5/2021

Document Id: 36db5700-ab76-4733-b948-5e98124fef86

Set id: 13bf1fe0-5167-497a-9a0e-34e8f8e5230a

Version: 2

Effective Time: 20210528