Mae by Damiva

Manufacturer
Damiva Inc. | Acino Products, LLC
Effective date
2018-12-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:10:40

Label at a glance#

ProductMae by Damiva
Active ingredientCALENDULA OFFICINALIS FLOWER, HAMAMELIS VIRGINIANA LEAF
Label structure7 sections

Label contents#

Full prescribing information#

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Calendula HPUS 1X and 

Hamamelis HPUS 6X:

each less than 1% w/w

OTC - PURPOSE SECTION

Purpose

Vaginal Discomfort

INDICATIONS & USAGE SECTION

Uses:  For soothing relief of vaginal discomfort, dryness, itching, odor and pain.  These uses are based solely on usage in homeopathic medicine.  This product has not been evaluated by the Food and Drug Administration for safety or efficacy. 

Warnings

WARNINGS SECTION

For vaginal use only. 

OTC - DO NOT USE SECTION

Do not use if you have an underlying gynecological medical condition or infection e.g. yeast or bacterial infection, sexually transmitted diseases, pelvic inflammatory disease, tenderness, swelling, discharge, chills, nausea, vomiting, rash or increased pain. 

OTC - ASK DOCTOR SECTION

If symptoms persist or worsen, or if new symptoms appear, consult a doctor as these could be signs of a serious condition. 

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or breast-feeding, ask a health professional before use. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  

OTHER SAFETY INFORMATION

Store at 68-77 °F. 

DOSAGE & ADMINISTRATION SECTION

Directions: Remove plastic wrap from ovule.  Using a clean finger, insert one suppository vaginally as far as comfortable.  Use as needed, or every 2 to 3 days, to a maximum of one ovule per day.  May use at bedtime to prevent product leakage.  Best results may occur after consecutive use of 10 ovules. 

INACTIVE INGREDIENT SECTION

Inactive ingredients:

Garcinia indica, Invert Sugar, Sucrose, Theobroma cacao (<30% w/w)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% natural
vaginal suppository.


Feel like a teenager again,
but with better judgement.

mae
by damiva

Homeopathic formula
10 ovule suppositories 1.9 g each. Net weight 19 g.

mae by damiva cartonmae by damiva carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69316-321-102021-01-29C16284748780-1ba0f9c33-4275-a910-e053-dadaa90a0b85Mae by Damiva

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69316-321-10Mae by Damiva10 in 1 BOXSUPPOSITORY105
69316-321-10Mae by Damiva1 in 1 CELLO PACKSUPPOSITORY15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69316-321MAE BY DAMIVA (CALENDULA AND HAMAMELIS) SUPPOSITORY [DAMIVA INC.]5Legacy NDC, 2 package rows20190101_7f4a11c3-95bf-419b-8460-ea9d946fc724.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERACTIVE INGREDIENTP0M7O4Y7YD3
HAMAMELIS VIRGINIANA LEAFACTIVE INGREDIENTT07U1161SV3
CALENDULA OFFICINALIS FLOWERACTIVE MOIETYP0M7O4Y7YD3
HAMAMELIS VIRGINIANA LEAFACTIVE MOIETYT07U1161SV3
COCOA BUTTERINACTIVE INGREDIENT512OYT1CRR3
GARCINIA INDICA SEED BUTTERINACTIVE INGREDIENTUS2H3D78003
SUCROSEINACTIVE INGREDIENTC151H8M5543

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69316-32169316-321-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 49 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SUCROSESUCROSEC151H8M554INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS900 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, CHEWABLE / ORAL7258 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SUSPENSION / ORAL40017 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554ELIXIR / ORAL18000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CONCENTRATE / ORAL4800 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, EXTENDED RELEASE / ORAL284.54 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS308 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED, EXTENDED RELEASE / ORAL86 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / INTRAVENOUS1950 mgExact identifier — unii candidate
48 equally ranked IID candidates
COCOA BUTTERCOCOA BUTTER512OYT1CRRSUPPOSITORY / RECTAL2280 mgExact identifier — unii candidate
SUCROSESUCROSEC151H8M554GRANULE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LIQUID / ORAL37500 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, DELAYED RELEASE / ORAL955 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS9.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, EXTENDED RELEASE / ORAL619 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, EMULSION / INTRAVENOUS970 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS2000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SOLUTION / ORAL42596 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / BUCCAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUPPOSITORY / RECTALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / BUCCALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / ORAL70000 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554DROPS / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED, EXTENDED RELEASE / ORAL119.12 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION / ORAL48209 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554LOZENGE / TRANSMUCOSAL1255 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION / ORAL31885 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE, COATED PELLETS / ORAL59.8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SYRUP / ORAL46400 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TROCHE / ORALNAExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, FILM COATED / ORAL145 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554PASTILLE / ORAL426 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER / ORAL27768 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554WAFER / ORAL155.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / SUBLINGUAL109 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL18790 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SOLUTION / RECTAL35.42 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, DELAYED RELEASE / ORAL295.33 mgExact identifier — unii candidate
48 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates

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
6031b8e2-9ac0-4b83-b870-d8d0c9c8d7b37f4a11c3-95bf-419b-8460-ea9d946fc7242018-12-31WarningsExact identifier
spl id: 6031b8e2-9ac0-4b83-b870-d8d0c9c8d7b3
spl set id: 7f4a11c3-95bf-419b-8460-ea9d946fc724

Reported adverse events (FAERS/openFDA)#

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