D-16

Manufacturer: DNA Labs, Inc.
Effective date: 2025-01-13
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 02:31:14

Label at a glance#

ProductD-16

Active ingredientBLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, SPIGELIA ANTHELMIA

Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0016-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Migraine, nervous headaches.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Cimicifuga racemosa 4x, Iris versicolor 2x, Sanguinaria canadensis 2x, Gelsemium sempervirens 3x, Spigelia anthelmia 4x

INACTIVE

INACTIVE INGREDIENT SECTION

20% alcohol in purified water.

SUGGESTED DOSAGE

DOSAGE & ADMINISTRATION SECTION

One dropper under tongue two times daily. Acute symptoms ½ dropper under tongue every 30 minutes for two hours.

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

If pregnant or breastfeeding, ask a healthcare professional before use.

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 16

HOMEOPATHIC
STRESS FORMULA

1 FL. OZ.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58264-0016-1	2022-06-02	C162847	48780-1	9d75b9d0-d4d7-f424-e053-dadaa90a57ce	D-16
58264-0016-1	2020-01-31	C162847	48780-1	9d75b9d0-d4d7-f424-e053-dadaa90a57ce	D-16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58264-0016-1	D-16	29.57 mL in 1 BOTTLE, GLASS	SOLUTION/ DROPS	29.57		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58264-0016	D-16 (BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIA) SOLUTION/ DROPS [DNA LABS, INC.]	3	Current NDC, Legacy NDC, 1 package rows	20250115_4784ddc2-c308-4092-a01f-ea2b2954a888.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

D-16
black cohosh, iris versicolor root, sanguinaria canadensis root, gelsemium sempervirens root, and spigelia anthelmia
ALCOHOL
WATER
BLACK COHOSH
IRIS VERSICOLOR ROOT
SANGUINARIA CANADENSIS ROOT
GELSEMIUM SEMPERVIRENS ROOT
SPIGELIA ANTHELMIA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58264-0016	58264-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALCOHOL	3K9958V90M	IACT
WATER	059QF0KO0R	IACT
BLACK COHOSH	K73E24S6X9	ACTIB
IRIS VERSICOLOR ROOT	X43D4L3DQC	ACTIB
SANGUINARIA CANADENSIS ROOT	N9288CD508	ACTIB
GELSEMIUM SEMPERVIRENS ROOT	639KR60Q1Q	ACTIB
SPIGELIA ANTHELMIA	WYT05213GE	ACTIB

Source Document#

Source XML

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
D-16	BLACK COHOSH, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT, GELSEMIUM SEMPERVIRENS ROOT, AND SPIGELIA ANTHELMIA	DNA Labs, Inc.	4784ddc2-c308-4092-a01f-ea2b2954a888	2025-01-13	Warnings	Exact identifier ndc (package): 58264-0016-1 ndc (product): 58264-0016 ndc11 (package): 58264001601 spl id: 2b9ea65c-9dfc-ad89-e063-6394a90ab44c spl set id: 4784ddc2-c308-4092-a01f-ea2b2954a888

Reported adverse events (FAERS/openFDA)#

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