FDA.reportPublic FDA data

D-88

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 02:31:10

Label at a glance#

ProductD-88
Active ingredientANAMIRTA COCCULUS SEED, SODIUM CHLORIDE, CHAMAELIRIUM LUTEUM ROOT, TRIBASIC CALCIUM PHOSPHATE, STRYCHNOS IGNATII SEED, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, BLACK COHOSH, PASSIFLORA INCARNATA FLOWERING TOP, VALERIAN, SEPIA OFFICINALIS JUICE, DIBASIC POTASSIUM PHOSPHATE, BOS TAURUS PITUITARY GLAND, POSTERIOR, ZINC, BOS TAURUS ADRENAL GLAND, BOS TAURUS OVARY
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0094-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Symptoms of P.M.S.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Cocculus indicus 6x, Natrum muriaticum 12x, Helonias dioica 5x, Calcarea phosphoricum 12x, Ignatia amara 6x, Magnesia phosphoricum 6x, Cimicifuga racemosa 4x, Passiflora incarnata 4x, Valeriana officinalis 4x, Sepia 10x, Kalium phosphoricum 6x, Zincum metallicum 8x, Pituitary 6x, Adrenal 6x, Ovarian 6x

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

  • 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 88

HOMEOPATHIC
STRESS FORMULA

1 FL. OZ.

PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label
PRINCIPAL DISPLAY PANEL - 1 FL. OZ. Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0094-12022-06-06C16284748780-19d75b9d0-3703-f424-e053-dadaa90a57ceD-88
58264-0094-12020-01-31C16284748780-19d75b9d0-3703-f424-e053-dadaa90a57ceD-88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0094-1D-8829.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0094D-88 (COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIAN) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_1eefff9c-d86c-44ef-b968-9a8c5a9c5403.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-009458264-0094-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ANAMIRTA COCCULUS SEED810258W28UACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
CHAMAELIRIUM LUTEUM ROOTDQV54Y5H3UACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
BLACK COHOSHK73E24S6X9ACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
VALERIANJWF5YAW3QWACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
BOS TAURUS PITUITARY GLAND, POSTERIOR7JM57I419KACTIB
ZINCJ41CSQ7QDSACTIB
BOS TAURUS ADRENAL GLANDM2776SWB29ACTIB
BOS TAURUS OVARY66LZN1C747ACTIB

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-88COCCULUS INDICUS, NATRUM MURIATICUM, HELONIAS DIOICA, CALCAREA PHOSPHORICUM, IGNATIA AMARA, MAGNESIA PHOSPHORICUM, CIMICIFUGA RACEMOSA, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, SEPIA, KALIUM PHOSPHORICUM, ZINCUM METALLICUM, PITUITARY, ADRENAL, OVARIANDNA Labs, Inc.1eefff9c-d86c-44ef-b968-9a8c5a9c54032025-01-13WarningsExact identifier
ndc (package): 58264-0094-1
ndc (product): 58264-0094
ndc11 (package): 58264009401
spl id: 2b9edb0e-499a-f422-e063-6294a90ae8fa
spl set id: 1eefff9c-d86c-44ef-b968-9a8c5a9c5403

Reported adverse events (FAERS/openFDA)#

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