Home › NDC Lookup › Ingredients › Camphor, Diphenhydramine, Zinc Acetate › 65753-0400-02
CoreTex Anti-Itch Gel camphor, diphenhydramine, zinc acetate 2 g/100mL; 1 g/100mL; .1 g/100mL Gel, 59 mL — NDC 65753-0400-02 package photo

CoreTex Anti-Itch Gel camphor, diphenhydramine, zinc acetate 2 g/100mL; 1 g/100mL; .1 g/100mL Gel, 59 mL

by CoreTex Products Inc · 59 mL in 1 BOTTLE (65753-400-02)
NDC 65753-0400-02
🏷️ FDA NDC (as labeled) 65753-400-02 billing pads the product segment with a zero
This package
Contains59 mL Pack sizes4 compare ↓
Also comes in: 25 pouches 65753-0400-13 177 ml 65753-0400-04 300 pouches 65753-0400-14
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 65753-400-02
Product NDC 65753-400
11-digit billing NDC 65753040002
RxCUI 2263170
UNII TC2D6JAD40, FM5526K07A, 5TJD82A1ET
UPC 0698229266637, 0698229266668
Application # M017
SPL Set ID 9849da49-d867-fae5-e053-2a95a90a399c
Established class (EPC) Copper Absorption Inhibitor; Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-11-25
Route TOPICAL
Dosage form GEL
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE; CAMPHOR (SYNTHETIC)
Why two NDCs? The FDA registers this code as 65753-400-02 — 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 → 65753-0400-02. 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.

🏭 Manufacturer & labeler

LabelerCoreTex Products Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code65753
First marketedNov 2019
Product typeHuman Otc Drug
Portfolio11 products on file
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?

CoreTex Anti-Itch Gel is a topical gel containing three active ingredients. Camphor and diphenhydramine are typically used to relieve itching and provide a cooling sensation on the skin. Zinc acetate is commonly used in topical products for its astringent properties. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of anti-itch preparation rather than through an individual product application.

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.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • UNII H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • 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.
  • UNII P0NTE48364
    A plant-based thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a viscosity modifier to control texture in liquid or semi-solid formulations.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII QRB8092KPK
    A synthetic liquid derived from propylene glycol, modified with an allyl ether group. It typically serves as a solvent, humectant, or preservative helper in liquid formulations to dissolve active ingredients and maintain product stability.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

10 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescitric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

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.

💲 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.
Try another pack size: 25 pouches 177 ml 300 pouches
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CoreTex Anti-Itch Gel 2 g/100mL; 1 g/100mL; .1 g/100mLthis 65753-0400-02 CoreTex 59 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

🏛️
2019
On the market since
Nov 2019
📍
2026
Currently FDA-listed
7 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
65753-0400-02 You're viewing this 59 mL in 1 BOTTLE (65753-400-02) 2019-11-26 Active
65753-0400-04 177 mL in 1 BOTTLE (65753-400-04) 2019-11-26 Active
65753-0400-13 25 POUCH in 1 CONTAINER (65753-400-13) / 1 mL in 1 POUCH 2019-11-26 Active
65753-0400-14 300 POUCH in 1 CONTAINER (65753-400-14) / 1 mL in 1 POUCH 2019-11-26 Active

Pack size FAQ

What quantity is in NDC 65753-0400-02?
NDC 65753-0400-02 contains 59 mL — 59 ml in 1 bottle.
What is the difference between NDC 65753-0400-02 and NDC 65753-0400-13?
Both are CoreTex Anti-Itch Gel camphor, diphenhydramine, zinc acetate 2 g/100mL; 1 g/100mL; .1 g/100mL Gel — the drug itself is identical. NDC 65753-0400-02 is the 59 mL package, while NDC 65753-0400-13 is the 25 pouches package.
What NDC number is used to bill for this package of CoreTex Anti-Itch Gel camphor, diphenhydramine, zinc acetate 2 g/100mL; 1 g/100mL; .1 g/100mL Gel?
Bill NDC 65753-0400-02 — the 11-digit billing format is 65753040002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 65753-400-02, 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: 65753-0400-02, written without dashes as 65753040002. 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 65753-0400-02, the first segment (65753) is the labeler code FDA assigned to CoreTex Products Inc; the middle segment (0400) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 CoreTex Products Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 25 pouches (65753-0400-13), 177 ml (65753-0400-04), 300 pouches (65753-0400-14). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
CoreTex Products 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 29 words ▾

Uses For the temporary relief of itching and pain associated with minor cuts, minor skin irritations and rashes due to insect bites, poison ivy, poison oak, and poison sumac.

⏱️ Dosage and Administration 34 words ▾

Directions Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

⚠️ Warnings 90 words ▾

Warnings For external use only. Do Not Use on chicken pox, blisters or on extensive areas of the skin with any drugs containing diphenhydramine while using this product. Avoid contact with the eyes more than directed When using the product: Keep out of eyes.

Stop use and ask a doctor if conditions worsen or if symptoms persist for more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If swallowed get medical help or contact Poison Control center right away.

🧪 Active Ingredient 10 words ▾

Active Ingredients Camphor 0.1% Diphenhydramine hydrochloride 2% Zinc acetate 1%

🧪 Inactive Ingredients 20 words ▾

Inactive Ingredients citric acid, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, SD alcohol 40, sodium citrate, water (aqua).

🎯 Purpose 7 words ▾

Purpose Extrenal analgesic External analgesic Skin protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 65753-0350-15 · CoreTex 65753-0510-24 · CoreTex →
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.