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Cooling Itch Relief 1 g/100g Spray, 85 g — NDC 13709-0310-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Cooling Itch Relief 1 g/100g Spray, 85 g — NDC 13709-310-01 (Billing 13709-0310-01)

by NeilMed Pharmaceuticals, Inc · 85 g in 1 CAN

This is a package of 85 g of Cooling Itch Relief 1 g/100g Spray from NeilMed Pharmaceuticals, Inc, marketed since Nov 2018 and currently FDA-listed. It is this product's only package size.

NDC 13709-0310-01
🏷️ FDA NDC (as labeled) 13709-310-01 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 Jul 24, 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 13709-310-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
13709 labeler · 310 product · 01 package
Package marketed since
Nov 8, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0311917206462
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 13709-310-01
Product NDC 13709-310
11-digit billing NDC 13709031001
RxCUI 317564
UNII WI4X0X7BPJ
UPC 0311917206462
Application # M017
SPL Set ID a24bdea0-18e8-8a5e-e053-2995a90acea2
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-11-08
Route TOPICAL
Dosage form SPRAY
Substance HYDROCORTISONE
Quick answers
  • RxCUI (RxNorm): 317564
Why two NDCs? The FDA registers this code as 13709-310-01 — 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 → 13709-0310-01. 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 Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids, moderately potent (group II), Corticosteroids, potent (group III), Corticosteroids for local oral treatment
How it works Corticosteroid Hormone Receptor 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 it is MedlinePlus · NLM

Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticosteroids. It works by activating natural substances in the skin to reduce swelling, redness, and itching.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It depends on the product. Tablets and oral granules are used for adrenal insufficiency, among other conditions. Injections are used for severe allergic states and skin diseases. R...
  • Don't stop it suddenly if you take it for adrenal insufficiency. Stopping abruptly can cause adrenal crisis, which can be fatal. Talk to your prescriber before making any changes.
  • Common ones are fluid retention, higher blood pressure, changes in blood sugar, mood changes, bigger appetite and weight gain. Call your doctor for signs of infection, vision chang...
  • Grapefruit juice and some antifungals and antibiotics can raise hydrocortisone levels. Some seizure medicines and rifampicin can lower them. Tell me about any diabetes medicines, w...
📖 Read our full Hydrocortisone guide →

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 mLPer 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
13709-0310-01 You're viewing this Main listing 85 g in 1 CAN 2018-11-08 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Anti Itch 1 g/100g 00363-9801-01 Walgreens 1 can — — FDA listed —
Rite Aid Cortisone 1 g/100g 11822-0113-03 Rite 85 g — — FDA listed —
Cooling Itch Relief 1 g/100gthis 13709-0310-01 NeilMed 85 g — — FDA listed —
Anti Itch 1 g/100g 13709-0327-01 Neilmed 1 can — — FDA listed —
Kroger Anti Itch 1 g/100g 30142-0270-03 The 85 g — — FDA listed —
Cortizone 10 Fast Acting Itch Relief Cooling 1 g/100g 41167-0343-00 Chattem, 76 g — — FDA listed —
Instant Cooling Itch Relief 10 mg/g 51316-0388-03 CVS 85 g — — FDA listed —
American Red Cross Anti-Itch 1 g/100g 51628-4527-01 MY 141 g — — FDA listed —
Hydrocortisone 1.13 g/113g 56104-0250-00 Premier 113 g — — FDA listed —
DCH Labs Cortisone 1 g/100g 72839-0113-03 Derma 85 g — — FDA listed —
American Red Cross Anti-Itch 1 g/100g 75742-0070-01 Zhejiang 141 g — — FDA listed —
Pediadermics Eczema 2 1.12 g/112g 76348-0585-04 RENU 112 g — — FDA listed —
Hydrocortisone 10 mg/mL 79481-9967-01 Meijer 74 ml — — FDA listed —
Equate Cortisone 1 g/100g 79903-0213-03 Walmart 85 g — — FDA listed —
Hydrocortisone 10 mg/mL 81522-0914-01 FSA 74 ml — — 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

🏛️
2018
On the market since
Nov 2018
📍
2026
Currently FDA-listed
8 years listed
🔒
·
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 1 g / 100 g UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesCitric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 marketedNov 2018
Product typeHuman Otc Drug

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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 140 words ▾

Indication & Usage For the temporary relief of itching associated with minor skin irritation and rashes due to: • eczema • poison ivy, oak and sumac • cosmetics • jewelry • soaps and detergents • insect bites. Other uses of this product should be only under the advice and supervision of a doctor. Warnings For external use only.

Flammable: Keep away from fire or flame Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not use for the treatment of diaper rash.

Consult a doctor. Do not puncture or incinerate. Contents under pressure.

Do not store at temperatures above 120˚F

⏱️ Dosage and Administration 13 words ▾

Dosage and Administration See Attached Image File Principal Display Panel Anti Itch Spray

⚠️ Warnings 5 words ▾

WARNINGS For external use only

🧪 Active Ingredient 14 words ▾

OTC Active Ingredient Section Hydrocortisone 1% Anti itch Principal Display Panel Anti Itch Spray.jpg

🧪 Inactive Ingredients 15 words ▾

INACTIVE INGREDIENT Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, Water

🎯 Purpose 33 words ▾

USES Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

📄 Do Not Use 25 words ▾

DO NOT USE • in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

📄 When Using This Product 35 words ▾

WHEN USING THIS PRODUCT • Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F

📄 Stop Use and Ask a Doctor If 32 words ▾

STOP USE AND ASK A DOCTOR IF • condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 48 words ▾

KEEP OUT OF REACH OF THE CHILDREN If swallowed, get medical help or contact a Poison Control Center right away

OTC - Keep Out of Reach of Children Keep out of reach of the children If swallowed, get medical help or contact a Poison Control Center right away

📄 Package Label / Principal Display Panel 4 words ▾

Anti-Itch Spray Anti-Itch Spray

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 ✓ Available
Inactive ingredients (structured) ✓ 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.
← 13709-0239-01 · NeilMed 13709-0311-01 · 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.