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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acolye Numbing Cream Anorectal(Hemorrhoidal) Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	578fa642-ff30-e511-e063-6294a90a5987	2026-07-26	Warnings	Exact identifier application number: M015
CVS Topical Anesthetic Hemorrhoidal	DIBUCAINE	CVS PHARMACY, INC	9f3d4fdb-ad82-4ab8-8a9e-252d027068ab	2026-07-25	Warnings	Exact identifier application number: M015
Moisture Barrier	MENTHOL 0.44%, ZINC OXIDE 20.6%	Walgreen Company	258f3392-0f42-21e8-e063-6294a90ae9ad	2026-07-22	Warnings	Exact identifier application number: M015
RectaEase Hemorrhoid Relief Cream	LIDOCAINE	Trifecta Pharmaceuticals USA LLC	c054921a-9f1b-7c75-e053-2995a90a1738	2026-07-20	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	KORVIA GLOBAL Inc.	5690db03-4d62-9660-e063-6394a90a2fc0	2026-07-14	Warnings	Exact identifier application number: M015
Gembooxt Topical Numbing Cream	LIDOCAINE HCL	Guangdong Quadrant Ecological Technology Co., Ltd.	49951a3e-3b62-3d66-e063-6294a90a9360	2026-07-13	Warnings	Exact identifier application number: M015
Zmztuhua Numbing Cream	LIDOCAINE	Guangzhou Hechuang Commercial Service Co.,Ltd.	56417dc6-c14b-ad17-e063-6294a90af7e5	2026-07-10	Warnings	Exact identifier application number: M015
Tina Davies IceCream	LIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	6a2b3199-f405-4455-9a02-8885d24eef9c	2026-07-09	Warnings	Exact identifier application number: M015
Drs pharmacy HEMORRHOIDAL	PHENYLEPHRINE HCL, WITCH HAZEL	OL PHARMA TECH, LLC Drs PHARMACY	164169b9-0627-9d1a-e063-6294a90ac46d	2026-07-09	Warnings	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	H E B	09b814f4-86b5-4810-bf52-cc88396451c2	2026-07-07	Warnings, Adverse reactions	Exact identifier application number: M015
Witch Hazel	WITCH HAZEL	ADUSA Distribution, LLC	c50d0496-6f09-43c2-9383-3250885968c9	2026-06-29	Warnings, Adverse reactions	Exact identifier application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal Cream	LIDOCAINE	Guangdong Aimu Biological Technology Co., Ltd	55260a3e-637a-c53b-e063-6394a90a1b09	2026-06-27	Warnings	Exact identifier application number: M015
Walgreens Hemorrhoidal	HEMORRHOIDAL RECTAL SUPPOSITORIES	Walgreens	20c41406-99b2-bc89-e063-6294a90aed73	2026-06-25	Warnings	Exact identifier application number: M015
CalaSoothe	CALAMINE, MENTHOL, AND ZINC OXIDE	Dynarex Corporation	54f12005-acfe-4821-e063-6394a90ac304	2026-06-24	Warnings	Exact identifier application number: M015
tina davies IceCream Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd	2026-06-24	Warnings	Exact identifier application number: M015
Haemorrhoidal Pain Relief	ANORECTAL CREAM	NeilMed Pharmaceuticals Inc	544a9d6f-4eaa-613e-e063-6294a90a0c50	2026-06-15	Warnings	Exact identifier application number: M015
Lidocaine Numbing Cream	LIDOCAINE	Guangzhou Liuquanmiao Import & Export Trade Co., Ltd.	5457b3d7-e6b6-34a7-e063-6394a90aa240	2026-06-15	Warnings	Exact identifier application number: M015
Dr.Seymour Butts Hemorrhoid	LIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOID	Jiangxi Yudexi Pharmaceutical Co., LTD	4981c7d9-53ee-2a7b-e063-6394a90add01	2026-06-12	Warnings	Exact identifier application number: M015
ANIXIKE Numbing	LIDOCAINE4% NUMBING	Jiangxi Yudexi Pharmaceutical Co., LTD	4d5b7c4c-feac-4eeb-e063-6294a90a5748	2026-06-11	Warnings	Exact identifier application number: M015
tina davies IceJelly Hemorrhoidal	LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE	TINA DAVIES PROFESSIONAL LLC	580559bf-d91f-4bb3-9c9b-b7e2cd0686fd	2026-06-11	Warnings	Exact identifier application number: M015

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
Ingredient	Strength
PHENYLEPHRINE HYDROCHLORIDE	2.5 mg/g
PRAMOXINE HYDROCHLORIDE	10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04JA59TNSJ	Internal UNII lookup
88AYB867L5	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f6622caa-3b31-9b07-e053-2a95a90a8a51	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83311-335-00	SIMPLE PROMISE Simple H Hemorrhoid Relief Cream	56.7 g in 1 TUBE	CREAM	56.7		2
83311-335-00	SIMPLE PROMISE Simple H Hemorrhoid Relief Cream	1 in 1 BOX	CREAM	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83311-335	SIMPLE PROMISE SIMPLE H HEMORRHOID RELIEF CREAM (PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE) CREAM [SIMPLE PROMISE PTE LTD]	2	Current NDC, 2 package rows	20231106_f6622caa-3b31-9b07-e053-2a95a90a8a51.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
04JA59TNSJ	PHENYLEPHRINE HYDROCHLORIDE	61-76-7	PHENYLEPHRINE HYDROCHLORIDE
88AYB867L5	PRAMOXINE HYDROCHLORIDE	637-58-1	PRAMOXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1293856	phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal Cream	PSN	f6622caa-3b31-9b07-e053-2a95a90a8a51	2
1293856	phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream	SCD	f6622caa-3b31-9b07-e053-2a95a90a8a51	2
1293856	phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal Cream	SY	f6622caa-3b31-9b07-e053-2a95a90a8a51	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83311-335-00	83311033500	1 TUBE in 1 BOX (83311-335-00) / 56.7 g in 1 TUBE	1 tube	2023-03-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SIMPLE PROMISE Simple H Hemorrhoid Relief Cream	SIMPLE PROMISE PTE LTD	2023-11-06	HUMAN OTC DRUG LABEL	2