FDA.reportPublic FDA data

YeastCalm

Product NDC
0220-9376
11-digit product format
002209376
Labeler code
0220
Product ID
0220-9376_47f736f6-9f39-b998-e063-6394a90a13c8
Type
HUMAN OTC DRUG
Nonproprietary name
SODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEAL
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Laboratoires Boirdon
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-01
Substance
CALENDULA OFFICINALIS FLOWERING TOP; CANDIDA ALBICANS; GOLDENSEAL; SODIUM BORATE
Active strength
1; 30; 5; 14 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
YeastCalm
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLDENSEAL1 [hp_X]/1
CALENDULA OFFICINALIS FLOWERING TOP30 [hp_X]/1
SODIUM BORATE5 [hp_X]/1
CANDIDA ALBICANS14 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZW3Z11D0JVInternal UNII lookup
18E7415PXQInternal UNII lookup
91MBZ8H3QOInternal UNII lookup
4D7G21HDBCInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cd384b93-b803-8810-e053-2a95a90acdf0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9376-622023-04-29C16284748780-1f386c649-cedb-0266-e053-dadaa90a7c1aYeastCalm
0220-9376-622023-01-30C16284748780-1f386c649-cedb-0266-e053-dadaa90a7c1aYeastCalm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9376-62YeastCalm7 in 1 BOXSUPPOSITORY73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9376YEASTCALM (SODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEAL) SUPPOSITORY [LABORATOIRES BOIRDON]2Current NDC, Legacy NDC, 1 package rows20230429_cd384b93-b803-8810-e053-2a95a90acdf0.zip

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
YeastCalmSODIUM BORATE,CALENDULA OFFICINALIS FLOWERING TOP,CANDIDA ALBICANS,GOLDENSEALLaboratoires Boirdoncd384b93-b803-8810-e053-2a95a90acdf02026-01-09WarningsExact identifier
ndc (product): 0220-9376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0220-9376-62002209376627 SUPPOSITORY in 1 BOX (0220-9376-62) 7 suppository2021-10-010000-00-00NoNoCurrent