NDC 13709-0354-01 — Cooling Gel 500 mg/g; 2.5 mg/g Gel, 1 tube

🆔 Identity & classification

FDA NDC (as labeled) 13709-354-01

Product NDC 13709-354

11-digit billing NDC 13709035401

RxCUI 249465

UNII 101I4J0U34, 1WS297W6MV

UPC 0705928150072

Application # M017

SPL Set ID 49fb637b-ecc5-1f9b-e063-6294a90ab41a

Established class (EPC) alpha-1 Adrenergic Agonist

Mechanism of action Adrenergic alpha1-Agonists

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2026-02-04

Route TOPICAL

Dosage form GEL

Substance WITCH HAZEL; PHENYLEPHRINE

Why two NDCs? The FDA registers this code as 13709-354-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 13709-0354-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist

Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use

How it works Adrenergic alpha1-Agonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerNeilMed Pharmaceuticals Inc.

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code13709

First marketedFeb 2026

Product typeHuman Otc Drug

Portfolio25 products on file

🔎 All NDCs from NeilMed Pharmaceuticals Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

Cooling Gel is a topical gel product sold as an over-the-counter monograph drug. It contains witch hazel, a plant extract commonly used in topical products for its astringent properties, and phenylephrine, an alpha-1 adrenergic agonist typically used to reduce swelling and constrict blood vessels in localized areas. Together, these ingredients are commonly found in products intended to provide cooling sensations and help reduce puffiness or minor irritation when applied to the skin.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per g	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Walgreens 2.5 mg/g; 500 mg/g 00363-6502-01	Walgreens	1 tube	—	—	FDA listed	—
Hemorrhoidal cooling gel 2.5 mg/g; 500 mg/g 00363-9712-01	WALGREENS	1 tube	—	—	FDA listed	—
Preparation H Cooling Gel 2.5 mg/g; 500 mg/g 00573-2840-10	Haleon	1 tube	—	—	FDA listed	—
Cooling Gel 500 mg/g; 2.5 mg/gthis 13709-0354-01	NeilMed	1 tube	—	—	FDA listed	—
Hemorroidal Cooling gel .5 g/100g; .25 g/100g 69396-0032-18	Trifecta	1 tube	—	—	FDA listed	—
Drmitsui Medical Haemorrhoid 50 g/100g; .25 g/100g 87267-0011-01	YIYANGYUAN	5 tubes	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2026

On the market since

Feb 2026

📍

2026

Currently FDA-listed

listed with the FDA

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
13709-0354-01 You're viewing this	1 TUBE in 1 CARTON (13709-354-01) / 25.5 g in 1 TUBE	2026-02-04	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 13709-354-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 13709-0354-01, written without dashes as 13709035401. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 13709-0354-01, the first segment (13709) is the labeler code FDA assigned to NeilMed Pharmaceuticals Inc.; the middle segment (0354) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NeilMed Pharmaceuticals Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

NeilMed Pharmaceuticals Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 36 words ▾

Uses • helps relieve the local itching and discomfort associated with hemorrhoids • temporarily shrinks hemorrhoidal tissue • provides temporary relief from irritation and burning • temporarily provides a cooling coating for relief of anorectal discomforts

⏱️ Dosage and Administration 67 words ▾

Directions Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe Gently dry by patting or blotting with a tissue or a soft cloth before applying cream When fi rst opening the tube, puncture foil seal with top end of cap Apply externally to the affected area up to 4 times daily Children under 12 years of age: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

📦 Storage and Handling 12 words ▾

Other information: Storage temperature: not to exceed 30°C (86°F). Protect from freezing.

🧪 Active Ingredient 10 words ▾

Drug Facts Active Ingredients Phenylephrine HCl 0.25% Witch Hazel 50%

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients: Aloe Barbadensis Leaf Extract, Edetate Disodium, Hydroxyethyl Cellulose, Methylparaben, Polysorbate 80, Propylene Glycol, Propylparaben, Purifi ed Water, Sodium Citrate, Sulisobenzone, Vitamin E Acetate.

🎯 Purpose 9 words ▾

Purpose Phenylephrine HCl 0.25% .......................................................................Vasoconstrictor Witch Hazel 50%. ............................................................................................Astringent

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All Pain Relief Cooling Gel NDCsSame ingredient 🏭 All NeilMed labeler NDCsLabeler code 13709 📚 All alpha-1 Adrenergic Agonist NDCsDrug class