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Cooling Gel 500 mg/g; 2.5 mg/g Gel, 1 tube — NDC 13709-354-01 (Billing 13709-0354-01)

by NeilMed Pharmaceuticals Inc. · 1 TUBE in 1 CARTON / 25.5 g in 1 TUBE

This is a package of 1 tube of Cooling Gel 500 mg/g; 2.5 mg/g Gel from NeilMed Pharmaceuticals Inc., marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 13709-0354-01
🏷️ FDA NDC (as labeled) 13709-354-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 13709-354-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
13709 labeler · 354 product · 01 package
Package marketed since
Feb 4, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0705928150072
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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
Quick answers
  • RxCUI (RxNorm): 249465
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.

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.

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.

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 systemPer gPer 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
13709-0354-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 25.5 g in 1 TUBE 2026-02-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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.

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.

Manufacturer & labeler

LabelerNeilMed Pharmaceuticals Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code13709
First marketedFeb 2026
Product typeHuman Otc Drug
Portfolio25 products on file

More NDCs from NeilMed Pharmaceuticals Inc. labeler code 13709

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.

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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

📄 Ask a Doctor Before Use If 30 words ▾

Ask a doctor before use if you have Heart disease High blood pressure Thyroid disease Diabetes Difficulty in urination due to enlargement of prostate gland unless directed by a doctor

📄 Ask a Doctor or Pharmacist Before Use If 21 words ▾

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

📄 When Using This Product 40 words ▾

When using this product do not exceed the recommended daily dosage unless directed by a doctor do not put in the rectum by using fi ngers or any mechanical device or applicator in case of bleeding, consult a doctor promptly.

📄 Stop Use and Ask a Doctor If 18 words ▾

Stop use and ask a doctor if Bleeding occurs Condition worsens or does not improve within 7 days.

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

📄 Other Information 13 words ▾

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

📄 Questions or Comments 6 words ▾

Questions or comments? 1 (877) 477-8633

📄 Package Label / Principal Display Panel 4 words ▾

Package Label Tube Box

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

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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.
← 13709-0353-01 · Neilmed 13709-0355-01 · NeilMed →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.