FDA.reportPublic FDA data

AZO

Manufacturer
i-Health, Inc.
Effective date
2025-11-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:37:25

Label at a glance#

ProductAZO Yeast Plus
Active ingredientCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each tablet):

Candida albicans30X

Kreosotum30X

Natrium muriaticum12X

Sulphur12X

OTC - PURPOSE SECTION

Purpose

Relief from vaginal itching, burning and discharge

Relief from vaginal itching, burning, odor and discharge

Relief from vaginal itching, burning, odor and discharge

Relief from vaginal itching, burning, odor and discharge

INDICATIONS & USAGE SECTION

Use:

See your doctor if this is the first time you have vaginal itching and discomfort to find out if you have a vaginal yeast infection.

  • Relieves the symptoms of itching and burning associated with vaginal yeast infections.
  • Relieves occasional vaginal odor and discharge.

WARNINGS SECTION

Warnings:

For oral use only. This product will not cure a yeast infection.

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor. 

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you

  • have vaginal itching and discomfort for the first time.
  • have abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a serious condition.
  • get vaginal yeast infections often (such as once a month or three in six months).
  • may have been exposed to human immunodeficiency virus (HIV) that causes AIDS.
OTC - STOP USE SECTION

Stop use and contact your physician if

  • your symptoms do not improve within 3 days or if symptoms last more than 7 days.
  • you get a rash, hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults: take one tablet orally three times a day as long as symptoms persist. Children: consult a physician prior to use.

  • For occasional support take one tablet per day. 

OTHER SAFETY INFORMATION

OtherInformation: Each one tablet dose contains 35 mg calcium. Store at room temperature. Do not expose to excessive heat, humidity or direct sunlight.

  • Tamper evident: tablets sealed in blisters. Do not use if blister foil or seal is open or damaged.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Dicalcium phosphate, fractionated cocunut and palm kernel oil, hypromellose, magnesium stearate, and microcrystalline cellulose.

GENERAL PRECAUTIONS SECTION

This is a homeopathic medicine that supports the body's own defense system. Because this product contains natural ingredients, color may vary.

OTC - QUESTIONS SECTION

For questions, concerns, or to report an adverse event, call (800) 722-3476

www.azoproducts.com

Distributed by i-Health, Inc.

55 Sebethe Drive,

Cromwell, CT 06416

Made in the USA with US and imported materials. 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AZO

Yeast Plus

Yeast Infection Symptom Relief:*

ITCHING

BURNING

Vaginal Symptom Relief:*

OCCASIONAL ODOR &

DISCHARGE

#1 MOST TRUSTED BRAND

___ Tablets 

Homeopathic Medicine  Lactose Free

* THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION

AZO 60 ctAZO 60 ct

AZO 20 ctAZO 20 ct

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49973-667-202024-01-30C16284748780-11030e365-0a8c-111a-e063-dadaa90a10e2AZO Yeast Plus
49973-667-202024-01-30C16284748780-11030e365-0a8c-111a-e063-dadaa90a10e2AZO Yeast Plus
49973-667-602024-01-30C16284748780-11030e365-0a8c-111a-e063-dadaa90a10e2AZO Yeast Plus
49973-667-602024-01-30C16284748780-11030e365-0a8c-111a-e063-dadaa90a10e2AZO Yeast Plus

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49973-667-20AZOYeast Plus20 in 1 BOXTABLET207
49973-667-20AZOYeast Plus1 in 1 BLISTER PACKTABLET17
49973-667-60AZOYeast Plus60 in 1 BOXTABLET607
49973-667-60AZOYeast Plus1 in 1 BLISTER PACKTABLET17
49973-667-62AZOYeast Plus120 in 1 BOXTABLET1207
49973-667-62AZOYeast Plus4 in 1 BLISTER PACKTABLET47

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBC1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SULFURACTIVE INGREDIENT70FD1KFU701
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD731
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBC1
CHLORIDE IONACTIVE MOIETYQ32ZN486981
SULFURACTIVE MOIETY70FD1KFU701
WOOD CREOSOTEACTIVE MOIETY3JYG22FD731
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49973-66749973-667-60, 49973-667-20, 49973-667-62

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
HYPROMELLOSES3NXW29V3WOIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CANDIDA ALBICANS4D7G21HDBCACTIB
WOOD CREOSOTE3JYG22FD73ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SULFUR70FD1KFU70ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-03-21full-release2026-06-01 02:26:27

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET / ORAL2442 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET / ORAL2 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
4 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
AZO Yeast PlusCANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, AND SULFURi-Health, Inc.22845cac-8011-4ea8-b35e-b72973eddb442025-11-07WarningsExact identifier
ndc (package): 49973-667-60
ndc (package): 49973-667-62
ndc (package): 49973-667-20
ndc (product): 49973-667
ndc11 (package): 49973066762
ndc11 (package): 49973066720
ndc11 (package): 49973066760
spl id: 43046fcc-ea74-5c9b-e063-6394a90ac3bb
spl set id: 22845cac-8011-4ea8-b35e-b72973eddb44

Reported adverse events (FAERS/openFDA)#

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