FDA.reportPublic FDA data

N-12

Manufacturer
DNA Labs, Inc.
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:30:25

Label at a glance#

ProductN-12
Active ingredientPHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, THYROID, UNSPECIFIED
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0210-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Physical weakness, mood swings, and premenstrual difficulties in women.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Acidum phosphoricum 6x, Cinchona officinalis 6x, Pulsatilla 6x, Phosphorus 6x, Acidum picricum 6x, Magnesia phosphorica 6x, Viburnum opulus 2x, Glandulars: Pituitary, Ovary, Adrenal, Thyroid 6/12/30/60/200x

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.

N-12
GYNE PLEX

HOMEOPATHIC ENDOCRINE

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
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0210-12022-06-06C16284748780-19d75b9d0-698b-f424-e053-dadaa90a57ceN-12
58264-0210-12020-01-31C16284748780-19d75b9d0-698b-f424-e053-dadaa90a57ceN-12

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0210-1N-1229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0210N-12 (PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIED) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_89ed00b4-5739-439e-bae9-e00b0b0d7222.zip

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
58264-021058264-0210-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PHOSPHORIC ACIDE4GA8884NNACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
PHOSPHORUS27YLU75U4WACTIB
PICRIC ACIDA49OS0F91SACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
VIBURNUM OPULUS WHOLEDIO510WJ04ACTIB
BOS TAURUS PITUITARY GLAND, POSTERIOR7JM57I419KACTIB
BOS TAURUS OVARY66LZN1C747ACTIB
BOS TAURUS ADRENAL GLANDM2776SWB29ACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB

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
N-12PHOSPHORIC ACID, CINCHONA OFFICINALIS BARK, ANEMONE PULSATILLA, PHOSPHORUS, PICRIC ACID, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, VIBURNUM OPULUS WHOLE, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS OVARY, BOS TAURUS ADRENAL GLAND, AND THYROID, UNSPECIFIEDDNA Labs, Inc.89ed00b4-5739-439e-bae9-e00b0b0d72222025-01-09WarningsExact identifier
ndc (package): 58264-0210-1
ndc (product): 58264-0210
ndc11 (package): 58264021001
spl id: 2b539b74-75a3-e36c-e063-6294a90ae2dd
spl set id: 89ed00b4-5739-439e-bae9-e00b0b0d7222

Reported adverse events (FAERS/openFDA)#

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