What is NDC 83311-335?

83311-335 is the product NDC for SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, Phenylephrine hydrochloride 2.5 mg/g; Pramoxine hydrochloride 10 mg/g cream, listed with the FDA by SIMPLE PROMISE PTE LTD. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

SIMPLE PROMISE Simple H Hemorrhoid Relief Cream (Phenylephrine hydrochloride, Pramoxine hydrochloride).

What is the active ingredient?

Phenylephrine hydrochloride, Pramoxine hydrochloride.

SIMPLE PROMISE PTE LTD, NDC labeler code 83311. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for SIMPLE PROMISE Simple H Hemorrhoid Relief Cream?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

NDC 83311-335

NDC codes

FDA NDC Directory

Product NDC (as listed)83311-335Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83311-0335Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
83311-335-00	8331103350083311033500	1 TUBE in 1 BOX (83311-335-00) / 56.7 g in 1 TUBEMarketed from Mar 6, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): SIMPLE PROMISE Simple H Hemorrhoid Relief Cream
Generic name (nonproprietary): phenylephrine hydrochloride, pramoxine hydrochloride
Active ingredients: Phenylephrine hydrochloride — 2.5 mg/gPramoxine hydrochloride — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: SIMPLE PROMISE PTE LTDNDC labeler code 83311
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 015
Marketing start: Mar 6, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha1-Agonists (Mechanism)
Identifiers: Product ID 83311-335_0976dfc5-c33b-11fe-e063-6294a90aa2bbSPL ID 0976dfc5-c33b-11fe-e063-6294a90aa2bbSPL set ID f6622caa-3b31-9b07-e053-2a95a90a8a51RxCUI 1293856UNII 04JA59TNSJ, 88AYB867L5
Pharmacologic class: alpha-1 Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N483311033500 followed by a unit qualifier and the quantity

Package 83311-0335-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Nov 6, 2023.

Indications (excerpt from the label)

Uses • for temporary relief of pain, soreness and burning • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoid tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 83311-335

What is NDC 83311-335?: 83311-335 is the product NDC for SIMPLE PROMISE Simple H Hemorrhoid Relief Cream, Phenylephrine hydrochloride 2.5 mg/g; Pramoxine hydrochloride 10 mg/g cream, listed with the FDA by SIMPLE PROMISE PTE LTD. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: SIMPLE PROMISE Simple H Hemorrhoid Relief Cream (Phenylephrine hydrochloride, Pramoxine hydrochloride).
What is the active ingredient?: Phenylephrine hydrochloride, Pramoxine hydrochloride.
Who is the labeler?: SIMPLE PROMISE PTE LTD, NDC labeler code 83311. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for SIMPLE PROMISE Simple H Hemorrhoid Relief Cream?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 015

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 015
Product	Strength	Form · route	Labeler	Product NDC
Hempvana Maximum Strength Pain Relief Topical Anesthetic Platinumlidocaine 5%	Lidocaine 5 g/100g	CreamTopical	Telebrands Corp	73287-040
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)lidocaine cream anorectal	Lidocaine 4 g/80g	CreamTopical	EveryMarket Inc	85833-002
Lidonumblidocaine 5%	Lidocaine .05 g/g	CreamTopical	Rising Pharma Holdings, Inc.	57237-353
Exchange Select Hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	Army & Air Force Exchange Service	55301-279
Preparation H Medicated Wipeswitch hazel	Witch hazel 5 g/1	ClothTopical	Haleon US Holdings LLC	0573-0557
Lidocaine anorectal creamlidocaine 5%	Lidocaine 5 g/100g	CreamTopical	EveryMarket Inc	85833-001
hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	Kroger Company	30142-279
hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	Meijer Distribution Inc	41250-279
hemorrhoidal maximum strength pain reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Kroger Company	30142-944
Oxifylidocaine 5%	Lidocaine 50 mg/g	CreamTopical	Weeks & Leo Compnay, INC.	11383-331
hemorrhoidalglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	Publix Super Markets Inc	56062-944
Black Label B Numblidocaine hydrochloride	Lidocaine hydrochloride 5 g/100mL	SprayTopical	SCALP TECH INC	82617-103
hemorrhoidalmineral oil, petrolatum, phenylephrine hcl	Mineral oil 14 g/100g + 2 more ingredients	OintmentRectal	Amazon.com Services LLC	72288-767
The Solutionlidocaine hydrochloride, epinephrine hydrochloride	Lidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mL	SprayTopical	SCALP TECH INC	82617-101
Good Sense Hemorrhoidal Maximum Strength Pain Reliefglycerin, phenylephrine hcl, pramoxine hcl, white petrolatum	Glycerin 14.4 g/100g + 3 more ingredients	CreamTopical	L. Perrigo Company	0113-0944
The Solution 2.0lidocaine	Lidocaine hydrochloride 5 g/100mL	SprayTopical	SCALP TECH INC	82617-102
Equaline Hemorrhoidalcocoa butter, phenylephrine hcl	Cocoa butter 2211 mg/1; Phenylephrine hydrochloride 6.5 mg/1	SuppositoryRectal	United Natural Foods, Inc. dba UNFI	41163-279
Walgreens Moisture Barriermenthol, and zinc oxide	Menthol .44 g/100g; Zinc oxide 20.6 g/100g	CreamTopical	Walgreen Company	0363-3680
The Solu Tionlidocaine hydrochloride and epinephrine hydrochloride	Lidocaine hydrochloride 5 g/100mL; Epinephrine hydrochloride .01 g/100mL	Aerosol, FoamTopical	SCALP TECH INC	82617-110
Maximum Strength Hemorrhoidal Cream with Aloeglycerin, phenylephine hci, pramoxine hci, petrolatum	White petrolatum 15 g/100g + 3 more ingredients	CreamTopical	Chain Drug Marketing Association	83324-330

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SIMPLE PROMISE Simple H Hemorrhoid Relief Cream NDC 83311-335