FDA.reportPublic FDA data

SIMPLE PROMISE Simple H Hemorrhoid Relief Cream

Product NDC
83311-335
11-digit product format
833110335
Labeler code
83311
Product ID
83311-335_0976dfc5-c33b-11fe-e063-6294a90aa2bb
Type
HUMAN OTC DRUG
Nonproprietary name
PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SIMPLE PROMISE PTE LTD
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-06
Substance
PHENYLEPHRINE HYDROCHLORIDE; PRAMOXINE HYDROCHLORIDE
Active strength
2.5; 10 mg/g; mg/g
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
SIMPLE PROMISE Simple H Hemorrhoid Relief Cream
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g
PRAMOXINE HYDROCHLORIDE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
88AYB867L5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1293856Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6622caa-3b31-9b07-e053-2a95a90a8a51Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83311-335-00SIMPLE PROMISE Simple H Hemorrhoid Relief Cream56.7 g in 1 TUBECREAM56.72
83311-335-00SIMPLE PROMISE Simple H Hemorrhoid Relief Cream1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83311-335SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM (PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) CREAM [SIMPLE PROMISE PTE LTD]2Current NDC, 2 package rows20231106_f6622caa-3b31-9b07-e053-2a95a90a8a51.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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
application number: M015
DibucaineDIBUCAINEAkron Pharma Inc.60469e43-ab6f-46d3-a1df-00e58275f5652025-01-12WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
application number: M015
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
application number: M015
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
application number: M015
THE SOLUTIONLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INCdf51623c-e0b6-8e86-e053-2995a90a59b22025-01-08WarningsExact identifier
application number: M015
frida mom Perineal Cooling Pad LinersWITCH HAZELFridababy, LLCa461ff3d-e115-4f15-a545-bacb502ff6cd2024-12-30WarningsExact identifier
application number: M015
frida mom Postpartum Recovery EssentialsWITCH HAZELFridababy, LLC2d26c6f2-5d31-4c07-9f40-2fbfcfbf12342024-12-30WarningsExact identifier
application number: M015
frida mom Perineal HealingWITCH HAZELFridababy, LLC6a58e2a8-c4d5-4078-b5f4-28504de1f0202024-12-30WarningsExact identifier
application number: M015
frida mom Labor and Delivery Plus Postpartum RecoveryWITCH HAZELFridababy, LLC4b5fc312-4c8c-4396-a70c-b1ed129038c72024-12-30WarningsExact identifier
application number: M015
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
application number: M015
BLISS GVS HEMORRHOIDALPHENYLEPHRINE HCLBliss GVS Pharma Limitedfceea303-2ea0-10e9-e053-6294a90a54922024-12-21WarningsExact identifier
application number: M015
DibucaineDIBUCAINE 1%Geri-Care Pharmaceuticals, Corpafe88610-5cac-960e-e053-2a95a90a7ba42024-12-20WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELPharmacy Value Alliance, LLC7276aab8-0297-2a55-e053-2a91aa0a8d212024-12-20WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M015
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
application number: M015
Rectal Care Cream RevivolLIDOCAINE 5%Derma Care Research Labsa1c75161-f84a-e996-e053-2a95a90ac0c52024-12-19WarningsExact identifier
application number: M015
DCH Numbing ReliefLIDOCAINE 5%Derma Care Research Labs, LLCffd70a31-7d0c-d2d0-e053-6394a90a86742024-12-19WarningsExact identifier
application number: M015
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
application number: M015
Moshe Numbing HemorrhoidalLIDOCAINE 5%Derma Care Research Labsfbd5b488-1921-e9b7-e053-6294a90aba702024-12-19WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1293856phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal CreamPSNf6622caa-3b31-9b07-e053-2a95a90a8a512
1293856phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCDf6622caa-3b31-9b07-e053-2a95a90a8a512
1293856phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal CreamSYf6622caa-3b31-9b07-e053-2a95a90a8a512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83311-335-00833110335001 TUBE in 1 BOX (83311-335-00) / 56.7 g in 1 TUBE1 tube2023-03-06NoNoCurrent