FDA.reportPublic FDA data

D-116

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 02:31:24

Label at a glance#

ProductD-116
Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM FLUORIDE, WOOD CREOSOTE, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Storage and handling

SHAKE WELL

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

NDC 58264-0122-1

INDICATIONS

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

Dental caries.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE

SPL UNCLASSIFIED SECTION

Calcarea carbonica 8x, 30x, Calcarea phosphoricum 8x, 30x, Calcarea fluorica 12x, 30x, Kreosotum 30x, Thuja occidentalis 4x, 30x

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 116

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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0122-12022-06-06C16284748780-19d75b9d0-baeb-f424-e053-dadaa90a57ceD-116
58264-0122-12020-01-31C16284748780-19d75b9d0-baeb-f424-e053-dadaa90a57ceD-116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0122-1D-11629.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0122D-116 (OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM FLUORIDE, WOOD CREOSOTE, AND THUJA OCCIDENTALIS LEAFY TWIG) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250115_d412056d-4c48-43ff-9d94-51165d0c8c87.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58264-012258264-0122-1

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
NameUNIIKind
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB

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-116OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM FLUORIDE, WOOD CREOSOTE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.d412056d-4c48-43ff-9d94-51165d0c8c872025-01-13WarningsExact identifier
ndc (package): 58264-0122-1
ndc (product): 58264-0122
ndc11 (package): 58264012201
spl id: 2b9ed994-a884-0e65-e063-6394a90aca84
spl set id: d412056d-4c48-43ff-9d94-51165d0c8c87

Reported adverse events (FAERS/openFDA)#

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