FDA.reportPublic FDA data

HYLAFEM

Product NDC
52747-255
11-digit product format
527470255
Labeler code
52747
Product ID
52747-255_108fa2fe-f7a1-4c68-927e-70ef523e81d0
Type
HUMAN OTC DRUG
Nonproprietary name
Boricum Acidum
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
U.S. PHARMACEUTICAL CORPORATION
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-12-09
Substance
BORIC ACID
Active strength
3 [hp_X]/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
HYLAFEM
Brand name suffix
BORICUM ACIDUM 3X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BORIC ACID3 [hp_X]/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R57ZHV85D4Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fcd50c95-2522-418f-a2f3-de7e22622363Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52747-255-03HYLAFEMBORICUM ACIDUM 3X1 in 1 CARTONSUPPOSITORY15
52747-255-03HYLAFEMBORICUM ACIDUM 3X3 in 1 CAPSULESUPPOSITORY35

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52747-255-03EA - Each52747-2552ae73dfe-cb48-4f14-99ee-656ca4c0b37912020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52747-255HYLAFEM BORICUM ACIDUM 3X (BORICUM ACIDUM) SUPPOSITORY [U.S. PHARMACEUTICAL CORPORATION]5Current NDC, Legacy NDC, 2 package rows20221119_fcd50c95-2522-418f-a2f3-de7e22622363.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
HYLAFEM BORICUM ACIDUM 3XBORICUM ACIDUMU.S. PHARMACEUTICAL CORPORATIONfcd50c95-2522-418f-a2f3-de7e226223632022-11-17Warnings, Adverse reactionsExact identifier
ndc (product): 52747-255

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52747-255-03527470255031 CAPSULE in 1 CARTON (52747-255-03) / 3 SUPPOSITORY in 1 CAPSULE1 capsule2019-12-090000-00-00NoNoCurrent