FDA.reportPublic FDA data

BLISS GVS HEMORRHOIDAL

Product NDC
72701-111
11-digit product format
727010111
Labeler code
72701
Product ID
72701-111_29c2797d-6f07-7c31-e063-6394a90a19b5
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine hcl
Dosage form
SUPPOSITORY
Route
RECTAL
Labeler
Bliss GVS Pharma Limited
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-05-25
Substance
PHENYLEPHRINE HYDROCHLORIDE
Active strength
6.25 mg/1
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
BLISS GVS HEMORRHOIDAL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE6.25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fceea303-2ea0-10e9-e053-6294a90a5492Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72701-111-12BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-12BLISS GVS HEMORRHOIDAL2 in 1 CARTONSUPPOSITORY23
72701-111-24BLISS GVS HEMORRHOIDAL4 in 1 CARTONSUPPOSITORY43
72701-111-24BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-48BLISS GVS HEMORRHOIDAL6 in 1 BLISTER PACKSUPPOSITORY63
72701-111-48BLISS GVS HEMORRHOIDAL8 in 1 CARTONSUPPOSITORY83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72701-111BLISS GVS HEMORRHOIDAL (PHENYLEPHRINE HCL) SUPPOSITORY [BLISS GVS PHARMA LIMITED]3Current NDC, 6 package rows20241222_fceea303-2ea0-10e9-e053-6294a90a5492.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 14 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
application number: M015
Bunnies Bum Anorectal NumbingLIDOCAINEFloCal Distributors LLC3712e151-d171-1c5d-e063-6294a90a36c02025-06-08WarningsExact identifier
application number: M015
RECOVERY NumbingLIDOCAINE HCLRenu Laboratories, LLCe4e05cae-56a6-b2b3-e053-2a95a90a104b2025-06-06WarningsExact identifier
application number: M015
Hemorrohoid Master CreamLIDOCAINE, PHENYLEPHRINE HCLEbanel Laboratories, Inc.36eccc74-107e-3914-e063-6294a90a18562025-06-06WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc36c9988b-9e61-ebbf-e063-6394a90a41142025-06-04WarningsExact identifier
application number: M015
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.36caf20d-116a-f86a-e063-6294a90a7b622025-06-04WarningsExact identifier
application number: M015
Quick NumbLIDOCAINEClinical Resolution Laboratory, Inc.351b95a6-e038-d9aa-e063-6294a90a41722025-05-29WarningsExact identifier
application number: M015
Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINERugby Laboratories Inc.f23c8cd1-98f9-41cd-84d4-cf01c2ede29a2025-05-29WarningsExact identifier
application number: M015
The Femme Fix Hemorrhoid TreatmentLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEPOPPY COLLECTIVE LLC5217b5d9-b835-4428-a6b3-e6b2556307422025-05-27WarningsExact identifier
application number: M015
MAXOCAINE Topical Anesthetic AnorectalLIDOCAINEPRIME COMMERCE, LLC26e8c867-8cb8-4a25-91b1-da45a1edd09a2025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINEEbanel Laboratories, Inc.35107403-55ae-c627-e063-6394a90a0b5c2025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc350e4d5e-dac7-ae4e-e063-6394a90a76b42025-05-27WarningsExact identifier
application number: M015
Numb25LIDOCAINE 5%Ebanel Laboratories, Inc350fd302-8fd5-5288-e063-6294a90aa3822025-05-27WarningsExact identifier
application number: M015
Numb 520LIDOCAINEEbanel Laboratories, Inc35095bed-0e91-c44a-e063-6294a90add6e2025-05-27WarningsExact identifier
application number: M015
Numb520LIDOCAINEClinical Resolution Laboratory, Inc.a0411950-c6ee-4427-acb6-3cef58b0e93e2025-05-15WarningsExact identifier
application number: M015
Numb25LIDOCAINEClinical Resolution Laboratory, Inc.cfcb839d-47b4-4925-bb30-97b64d20d2b32025-05-15WarningsExact identifier
application number: M015
Numb520LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEClinical Resolution Laboratory, Inc.65d3b614-361d-4fb9-9583-a95be754bc822025-05-15WarningsExact identifier
application number: M015
ChamosynBARRIER CREAMLinks Medical Productsf9dfb2d7-4684-4525-994e-1e0ff90413d92025-05-08WarningsExact identifier
application number: M015
LANOZEM HEMORRHOIDALMENTHOL, PETROLATUMSod-e Biotech Ltd34901e83-8f24-8460-e063-6394a90a27442025-05-07WarningsExact identifier
application number: M015
PREPARATION HPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC96d2e0e7-2de0-4660-9ffd-9edb2ad224d82025-04-18WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72701-111-12727010111122 BLISTER PACK in 1 CARTON (72701-111-12) / 6 SUPPOSITORY in 1 BLISTER PACK2 blister pack2023-05-25NoNoCurrent
72701-111-24727010111244 BLISTER PACK in 1 CARTON (72701-111-24) / 6 SUPPOSITORY in 1 BLISTER PACK4 blister pack2023-05-25NoNoCurrent
72701-111-48727010111488 BLISTER PACK in 1 CARTON (72701-111-48) / 6 SUPPOSITORY in 1 BLISTER PACK8 blister pack2023-05-25NoNoCurrent