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

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 Identifiers#

Field, Values table
FieldValues
Unii04JA59TNSJ, 88AYB867L5
Rxcui1293856

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

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 tube2023-03-06NoNoHistorical