FDA.reportPublic FDA data

Xyralid Hemorrhoidal

Product NDC
57483-410
11-digit product format
574830410
Labeler code
57483
Product ID
57483-410_cd6eb255-a89d-40c5-90a0-13f907ab0ad5
Type
HUMAN OTC DRUG
Nonproprietary name
Hemorrhoidal Suppositories
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Innovus Pharmaceuticals, Inc.
Application
part346
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2018-03-25
Substance
COCOA BUTTER; PHENYLEPHRINE HYDROCHLORIDE
Active strength
88.5; .26 g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Xyralid Hemorrhoidal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COCOA BUTTER88.5 g/100g
PHENYLEPHRINE HYDROCHLORIDE.26 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
512OYT1CRRInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1438497Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8a885822-42e7-44e0-82d6-fa967123866eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57483-410-12Xyralid Hemorrhoidal24 g in 1 BLISTER PACKSUPPOSITORY241
57483-410-13Xyralid Hemorrhoidal4 in 1 CARTONSUPPOSITORY41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57483-410XYRALID HEMORRHOIDAL (HEMORRHOIDAL SUPPOSITORIES) SUPPOSITORY [INNOVUS PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 2 package rows20180504_8a885822-42e7-44e0-82d6-fa967123866e.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
Xyralid HemorrhoidalHEMORRHOIDAL SUPPOSITORIESInnovus Pharmaceuticals, Inc.8a885822-42e7-44e0-82d6-fa967123866e2018-05-03WarningsExact identifier
ndc (product): 57483-410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN8a885822-42e7-44e0-82d6-fa967123866e1
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD8a885822-42e7-44e0-82d6-fa967123866e1
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY8a885822-42e7-44e0-82d6-fa967123866e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57483-410-125748304101224 g in 1 BLISTER PACK24 gHistorical
57483-410-13574830410134 BLISTER PACK in 1 CARTON (57483-410-13) / 24 g in 1 BLISTER PACK (57483-410-12) 4 blister pack2018-03-250000-00-00NoNoCurrent