FDA.reportPublic FDA data

D14

Manufacturer
DNA Labs, Inc.
Effective date
2026-02-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:37:44

Label at a glance#

ProductD14
Active ingredientAVENA SATIVA WHOLE, VALERIANA OFFICINALIS WHOLE, HUMULUS LUPULUS WHOLE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII WHOLE, ZINC VALERATE DIHYDRATE, CHAMOMILE, ESCHSCHOLZIA CALIFORNICA, PASSIFLORA INCARNATA WHOLE, POTASSIUM BROMIDE
Label structure7 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0014-2

INDICATIONS & USAGE SECTION

INDICATIONS

OTC - PURPOSE SECTION

Insomnia and various disturbances of sleep.

OTC - ACTIVE INGREDIENT SECTION

Zincum valerianicum 9c, Ignatia amara 6x, Chamomilla vulgaris, Coffea cruda 4x, Kali bromatum 3x, Eschscholtzia californica, Humulus lupulus, Passiflora incarnata, Valeriana officinalis 2x, Avena sativa 1x

INGREDIENTS

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

One dropper full under the tongue two times daily. In acute conditions 5-10 drops under the tongue every 20-30 minutes.

STORAGE AND HANDLING SECTION

SHAKE WELL

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

  • Use only if cap seal is unbroken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • As with drugs if you are pregnant or nursing a baby seek professional advice before using this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep this and all medication out of the reach of children.

SPL UNCLASSIFIED SECTION

To be used according to standard homeopathic indications.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DYNAMIC

NUTRITIONAL

ASSOCIATES, INC.

D 14

HOMEOPATHIC FORMULA

1 FL. OZ.

D14 LabelD14 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0014-12022-06-02C16284748780-19d75b9d0-ed1f-f424-e053-dadaa90a57ceD-14
58264-0014-12020-01-31C16284748780-19d75b9d0-ed1f-f424-e053-dadaa90a57ceD-14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-1014-1D1429.57 mL in 1 BOTTLE, GLASSSOLUTION29.574

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-101458264-1014-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
AVENA SATIVA WHOLE5P8D0Z74RGACTIB
VALERIANA OFFICINALIS WHOLEFP6O7F1X9RACTIB
HUMULUS LUPULUS WHOLE912A6Q1N4AACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS IGNATII WHOLE6YSJ329777ACTIB
ZINC VALERATE DIHYDRATEMN0RX54EQAACTIB
CHAMOMILEFGL3685T2XACTIB
ESCHSCHOLZIA CALIFORNICA9315HN272XACTIB
PASSIFLORA INCARNATA WHOLER48E2W2LMOACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D14ZINCUM VALERIANICUM, IGNATIA AMARA, CHAMOMILLA VULGARIS, COFFEA CRUDA, KALI BROMATUM, ESCHSCHOLTZIA CALIFORNICA, HUMULUS LUPULUS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, AVENA SATIVADNA Labs, Inc.4096bbed-b752-4082-a07c-79fc497fb8cc2026-02-25WarningsExact identifier
ndc (package): 58264-1014-1
ndc (product): 58264-1014
ndc11 (package): 58264101401
spl id: 4baa48bc-4b31-969d-e063-6394a90ad1d6
spl set id: 4096bbed-b752-4082-a07c-79fc497fb8cc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.