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NDC 13838-1448-01 Valeriana officinalis (N) 1 [hp_X]/mL Details

Valeriana officinalis (N) 1 [hp_X]/mL

Valeriana officinalis (N) is a ORAL TINCTURE in the HUMAN OTC DRUG category. It is labeled and distributed by Phytodyne Inc.. The primary component is VALERIAN.

Product Information

NDC	13838-1448
Product ID	13838-1448_56a7c9a6-9a5d-41c7-b6b9-0d50bbd3dd71
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	Valeriana officinalis (N)
Proprietary Name Suffix	n/a
Non-Proprietary Name	VALERIAN
Product Type	HUMAN OTC DRUG
Dosage Form	TINCTURE
Route	ORAL
Active Ingredient Strength	1
Active Ingredient Units	[hp_X]/mL
Substance Name	VALERIAN
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 13838-1448-01 (13838144801)

Pricing Information	N/A
NDC Package Code	13838-1448-1
Billing NDC	13838144801
Package	20 mL in 1 BOTTLE, GLASS (13838-1448-1)
Marketing Start Date	2005-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 54ca25d1-b176-4d83-b659-e026c0545231 Details

Use

For sleeplessness and states of restlessness

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

Valeriana officinalis Ø (N)

SPL UNCLASSIFIED SECTION

Alcohol: 65

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

Valeriana officinalis Ø (N)

Use: For sleeplessness and states of restlessness

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

VALERIANA OFFICINALIS (N)

valerian tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13838-1448
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	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:13838-1448-1	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: 56a7c9a6-9a5d-41c7-b6b9-0d50bbd3dd71

Set id: 54ca25d1-b176-4d83-b659-e026c0545231

Version: 2

Effective Time: 20211216