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NDC 13838-1433-01 Solidago comp. .15; .2; .1; .4; .15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Solidago comp. .15; .2; .1; .4; .15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Solidago comp. is a ORAL SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Phytodyne Inc.. The primary component is BETULA PENDULA LEAF; EQUISETUM ARVENSE TOP; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA DIOICA WHOLE.

Product Information

NDC	13838-1433
Product ID	13838-1433_d99a2f54-f771-4d33-bd72-5f0667d9b465
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	Solidago comp.
Proprietary Name Suffix	n/a
Non-Proprietary Name	Solidago Virgaurea Flowering Top, Equisetum Arvense Top, Urtica Dioica, Betula Pendula Leaf, and Sambucus Nigra Flowering Top
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	ORAL
Active Ingredient Strength	.15; .2; .1; .4; .15
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	BETULA PENDULA LEAF; EQUISETUM ARVENSE TOP; SAMBUCUS NIGRA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; URTICA DIOICA WHOLE
Labeler Name	Phytodyne Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2023-12-31

Package

Package Images

NDC 13838-1433-01 (13838143301)

Pricing Information	N/A
NDC Package Code	13838-1433-1
Billing NDC	13838143301
Package	20 mL in 1 BOTTLE, GLASS (13838-1433-1)
Marketing Start Date	2005-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 1b3547c8-75e2-4840-8d81-165c257238cc Details

Use

For urinary discomfort

Directions

Adults and children above 12 years: 2-5 drops 1-3 times daily in pure water before meals. Consult a physician for use in children under 12 years of age.

Ingredients

Solidago virgaurea Ø (N) 40%, Equisetum arvense Ø (M) 20%, Urtica dioica Ø (M) 15%, Betula pendula Ø (N) 15%, Sambucus nigra Ø (N) 10%

SPL UNCLASSIFIED SECTION

Alcohol: 55

TAMPER-EVIDENT

Do not use if tamper evident strip is broken from base of cap.

WARNING

Ask a doctor if you are pregnant or nursing.

Keep away from children. In case of overdose, call a medical professional.

PRINCIPAL DISPLAY PANEL - 20 ml Bottle Label

CERES®

Homeopathic Medicine

Solidago comp.

Use: For urinary discomfort

Directions : Adults and children above 12 years: 2-5

drops 1-3 times daily in pure water before meals. Consult

a physician for use in children under 12 years of age.

0.67 fl.oz. (20ml)

Lot#:1234567A

EXP: 99.9999

Principal Display Panel - 20 ml Bottle Label

INGREDIENTS AND APPEARANCE

SOLIDAGO COMP.

solidago virgaurea flowering top, equisetum arvense top, urtica dioica, betula pendula leaf, and sambucus nigra flowering top solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13838-1433
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	0.4 [hp_X] in 1 mL
EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z)	EQUISETUM ARVENSE TOP	0.2 [hp_X] in 1 mL
URTICA DIOICA WHOLE (UNII: 710FLW4U46) (URTICA DIOICA WHOLE - UNII:710FLW4U46)	URTICA DIOICA WHOLE	0.15 [hp_X] in 1 mL
BETULA PENDULA LEAF (UNII: 5HW39H9KDH) (BETULA PENDULA LEAF - UNII:5HW39H9KDH)	BETULA PENDULA LEAF	0.15 [hp_X] in 1 mL
SAMBUCUS NIGRA FLOWERING TOP (UNII: CT03BSA18U) (SAMBUCUS NIGRA FLOWERING TOP - UNII:CT03BSA18U)	SAMBUCUS NIGRA FLOWERING TOP	0.1 [hp_X] in 1 mL

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

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13838-1433-1	20 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	10/01/2005

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		10/01/2005

Labeler - Phytodyne Inc. (164980927)

Revised: 12/2021

Document Id: d99a2f54-f771-4d33-bd72-5f0667d9b465

Set id: 1b3547c8-75e2-4840-8d81-165c257238cc

Version: 2

Effective Time: 20211214