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CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant BENZOCAINE, WHITE PETROLATUM 100 mg/g; 446.9 mg/g Cream — NDC 10210-0048-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant BENZOCAINE, WHITE PETROLATUM 100 mg/g; 446.9 mg/g Cream — NDC 10210-0048-1 (Billing 10210-0048-01)

by Carma Laboratories, Inc. · 1 TUBE in 1 BLISTER PACK / 2 g in 1 TUBE

This is a package of CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant BENZOCAINE, WHITE PETROLATUM 100 mg/g; 446.9 mg/g Cream from Carma Laboratories, Inc., marketed since Jul 2020 and currently FDA-listed. It is this product's only package size.

NDC 10210-0048-01
🏷️ FDA NDC (as labeled) 10210-0048-1 billing pads the package 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 10210-0048-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
10210 labeler · 0048 product · 1 package
Package marketed since
Jul 1, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1021000481 2
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10210-0048-1
Product NDC 10210-0048
11-digit billing NDC 10210004801
RxCUI 2479726
UNII U3RSY48JW5, B6E5W8RQJ4
Application # M017
SPL Set ID bbf0abcd-b7d6-b5e4-e053-2995a90a5240
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-07-01
Route TOPICAL
Dosage form CREAM
Substance BENZOCAINE; WHITE PETROLATUM
Quick answers
  • RxCUI (RxNorm): 2479726
Why two NDCs? The FDA registers this code as 10210-0048-1 — a 5-4-1 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 package segment → 10210-0048-01. 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 Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Esters of aminobenzoic acid
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?

This is a topical cream marketed for cold sore treatment. It contains benzocaine, a local anesthetic that is typically used to numb pain and discomfort on the skin surface, and white petrolatum, a skin protectant that is commonly used to help moisturize and protect affected areas. The product is sold as an over-the-counter monograph drug, meaning it follows established FDA guidelines for this category rather than being individually reviewed.

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
10210-0048-01 You're viewing this Main listing 1 TUBE in 1 BLISTER PACK / 2 g in 1 TUBE 2020-07-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
CARMEX Multi-Symptom 3 in 1 COLD Sore treatment External Analgesic Skin Protectant 100 mg/g; 446.9 mg/gthis 10210-0048-01 Carma 1 tube — — 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

🏛️
2020
On the market since
Jul 2020
📍
2026
Currently FDA-listed
6 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.

  • UNII NGS1GGK4GW
    A plant-derived emollient and emulsifier made from olive oil and behenic acid. It helps blend oil and water ingredients together in formulations and provides a smooth texture.
  • UNII S4255P4G5M
    Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
  • UNII 1K09F3G675
    Ferric oxide red is an inorganic iron compound used as a colorant in medicines. It gives tablets, capsules, or other dosage forms a red or reddish tint for identification and appearance.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII WB5K9Y35Y9
    A synthetic crosslinked polymer made by combining hexamethylene diisocyanate with trimethylol hexyllactone. It's used as a film-former and binder to help create protective coatings on tablets or capsules and improve product stability.
  • UNII 949E3KBJ1I
    Isopropyl titanium triisostearate is a titanium-based compound used in medicines as a glidant and anticaking agent. It helps powders and granules flow smoothly during manufacturing and prevents clumping in the finished product.
  • UNII V8A1AW0880
    Mica is a naturally occurring mineral that's ground into fine powder. It's used in medicines as a colorant and anti-caking agent to improve appearance and prevent clumping in tablets or powders.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII KQ9JG3O3YA
    A synthetic polymer made from propylene glycol and isocyanate compounds. It functions as a film-former and binder in medications, helping create protective coatings on tablets or holding ingredients together in solid dosage forms.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII KM7N50LOS6
    Tin oxide is an inorganic mineral compound used in medicines as a colorant and opacifying agent. It provides white or off-white color to tablets, capsules, and coatings while helping make formulations less transparent.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesPolyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)

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

LabelerCarma Laboratories, Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code10210
First marketedJul 2020
Product typeHuman Otc Drug
Portfolio56 products on file

More NDCs from Carma Laboratories, Inc. labeler code 10210

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 26 words ▾

Uses • For temporary relief of pain and itching associated with symptoms of fever blisters and cold sores • Helps prevent and protect dry, chapped lips

⏱️ Dosage and Administration 92 words ▾

Directions Using clean, dry hands apply 1 to 2 small dollops of Carmex Cold Sore product to the tip of the finger and gently apply and spread evenly to the surface of the cold sore to ensure even coverage over areas of redness. Wash hands thoroughly after application. Adults and children 2 years of age and older Apply to affected area (lips) not more than 3 to 4 times daily Children 2-12 years of age Should be supervised in use of this product Children under 2 years of age Ask a doctor

⚠️ Warnings 116 words ▾

Warnings For external use only Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other “caine” anesthetic Stop use and ask a doctor or dentist if • cold sore symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops Do not use on • deep or puncture wounds • animal bites • serious burns When using this product keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 12 words ▾

Active Ingredients Benzocaine 10% White Petrolatum 44.69% Purpose External Analgesic Skin Protectant

🧪 Inactive Ingredients 34 words ▾

Inactive Ingredients: Polyethylene Glycol, HDI/Trimethylol Hexyllactone Crosspolymer, Titanium Dioxide, Behenyl Olivate, PPG-51 SMDI Copolymer, Mica, Synthetic Wax, Calcium Silicate, Flavor, Isopropyl Titanium Triisostearate, Silica, Tin Oxide, Iron Oxides (C.I 77491, C.I 77492, C.I. 77499)

🎯 Purpose 5 words ▾

Purpose External Analgesic Skin Protectant

📄 Do Not Use 15 words ▾

Do not use on • deep or puncture wounds • animal bites • serious burns

📄 When Using This Product 18 words ▾

When using this product keep out of eyes. Rinse with water to remove. Do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor or dentist if • cold sore symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 4 words ▾

Package Labeling: Label4 Label5

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 Carma Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Carma Laboratories, 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.
← 10210-0047-01 · Carma 10210-0049-01 · Carma →
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.