Search by Drug Name or NDC

NDC 57687-0200-10 Bach Original Flower Remedies Agrimony 5 [hp_X]/.095mL Details

Bach Original Flower Remedies Agrimony 5 [hp_X]/.095mL

Bach Original Flower Remedies Agrimony is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Nelsons Bach USA Limited. The primary component is AGRIMONIA EUPATORIA FLOWER.

Product Information

NDC	57687-0200
Product ID	57687-200_d93f5881-c7e6-ba4c-e053-2a95a90a366e
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	Bach Original Flower Remedies Agrimony
Proprietary Name Suffix	n/a
Non-Proprietary Name	AGRIMONIA EUPATORIA
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	[hp_X]/.095mL
Substance Name	AGRIMONIA EUPATORIA FLOWER
Labeler Name	Nelsons Bach USA Limited
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 57687-0200-10 (57687020010)

Pricing Information	N/A
NDC Package Code	57687-200-10
Billing NDC	57687020010
Package	1 BOTTLE, DROPPER in 1 CARTON (57687-200-10) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2022-09-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL d93f5881-c7e5-ba4c-e053-2a95a90a366e Details

Active Ingredient

Agrimony (Agrimonia eupatoria) 5X HPUS

‘HPUS’ indicates the ingredient is in the official Homeopathic Pharmacopoeia of the United States

Purpose

Communicate openly

Use

For relief of naturally occurring simple nervous tension

Warnings

Consult a doctor if symptoms last for more than 7 days or worsen

Keep out of reach of children.

If pregnant or breast-feeding, ask a health professional before use.

Directions

Take 2 drops directly on the tongue or add to a beverage & sip. Repeat as needed throughout the day.

Children under 2: ask a doctor before use.

Other information

Store below 77 oF (25 oC)

Do not use if tamper evident seal around bottle neck is missing or broken

Inactive ingredients

glycerin [vegetable], purified water

Questions

800-319-9151 8am-5pm (EST) Mon-Fri

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BACH ORIGINAL FLOWER REMEDIES AGRIMONY

agrimonia eupatoria solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57687-200
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AGRIMONIA EUPATORIA FLOWER (UNII: 5811MI029U) (AGRIMONIA EUPATORIA FLOWER - UNII:5811MI029U)	AGRIMONIA EUPATORIA FLOWER	5 [hp_X] in 0.095 mL

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57687-200-10	1 in 1 CARTON	09/20/2022
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		09/20/2022

Labeler - Nelsons Bach USA Limited (877720193)

Registrant - A. Nelson & Co. Limited (221471234)

Name	Address	ID/FEI	Business Operations
Establishment
A. Nelsons & Co. Limited		221471234	manufacture(57687-200)

Revised: 9/2022

Document Id: d93f5881-c7e6-ba4c-e053-2a95a90a366e

Set id: d93f5881-c7e5-ba4c-e053-2a95a90a366e

Version: 1

Effective Time: 20220926