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OXY Sensitive Face Wash Maximum Soothing Benzoyl Peroxide 50 mg/mL Lotion, 185 mL — NDC 10742-1313-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OXY Sensitive Face Wash Maximum Soothing Benzoyl Peroxide 50 mg/mL Lotion, 185 mL — NDC 10742-1313-2 (Billing 10742-1313-02)

by The Mentholatum Company · 185 mL in 1 TUBE

This is a package of 185 mL of OXY Sensitive Face Wash Maximum Soothing Benzoyl Peroxide 50 mg/mL Lotion from The Mentholatum Company, marketed since Aug 2016 and currently FDA-listed.

NDC 10742-1313-02
🏷️ FDA NDC (as labeled) 10742-1313-2 billing pads the package segment with a zero
This package
Contains185 mL Pack sizes2 compare ↓
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 →

NDC database record

One package, one record: these facts belong to NDC 10742-1313-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
10742 labeler · 1313 product · 2 package
Package marketed since
Aug 1, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1074213132 1
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzoyl Peroxide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Feb 24, 2025 — Chemical Contamination: Presence of benzene. (Denison Pharmaceuticals, LLC) · FDA recall D-0273-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10742-1313-2
Product NDC 10742-1313
11-digit billing NDC 10742131302
RxCUI 308696
UNII W9WZN9A0GM
Application # M006
SPL Set ID c02ff802-fe48-41fb-a9dd-6a74da334a52
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-08-01
Route TOPICAL
Dosage form LOTION
Substance BENZOYL PEROXIDE
Quick answers
  • RxCUI (RxNorm): 308696
Why two NDCs? The FDA registers this code as 10742-1313-2 — 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 → 10742-1313-02. 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.

RxNorm drug class

This medicine belongs to the Peroxides class.

Drug family (ATC) Peroxides
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

Benzoyl peroxide is used to treat mild to moderate acne.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Most products are for acne. They dry up pimples and help prevent new ones. Epsolay is a prescription cream for rosacea bumps in adults. The Folliculitis Treatment Cream products ar...
  • For many acne products, start with once a day. You can move up to two or three times daily if your skin tolerates it. If you get dryness or peeling, cut back to once daily or every...
  • Redness, dryness, peeling, itching, and stinging or burning are the usual ones. Using less often can help. Using another acne product at the same time makes irritation more likely.
  • Stop if irritation gets severe. Stop right away and get help if you have hives, swelling or trouble breathing. Those can be signs of a serious allergic reaction.
📖 Read our full Benzoyl Peroxide guide →

Supplement & herbal interactions

Some supplements/herbs that may interact with Benzoyl Peroxide — tap one for details:

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.
Try another pack size: 148 ml
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
10742-1313-01 10742-1313-1 Main listing 148 mL in 1 TUBE 2016-08-01 — Active
10742-1313-02 You're viewing this 185 mL in 1 TUBE 2016-08-01 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 185 mL — 185 ml in 1 tube.
How does this package differ from NDC 10742-1313-01?
Both are OXY Sensitive Face Wash Maximum Soothing Benzoyl Peroxide 50 mg/mL Lotion — the drug itself is identical. This page's package is the 185 mL one, while NDC 10742-1313-01 is the 148 ml package.
What NDC number is used to bill for this package of OXY Sensitive Face Wash Maximum Soothing Benzoyl Peroxide 50 mg/mL Lotion?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Rugby Benzoyl Peroxide Wash Acne Medication 50 mg/mL 00536-1259-19 Rugby 236 ml $0.028 — Availability likely —
Benzoyl Peroxide 50 mg/mL 35573-0453-08 Burel 237 ml $0.045 — Availability likely —
benzoyl peroxide 5 g/100g 45802-0280-01 Padagis 142 g $0.052 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1057-75 Rugby 1 tube $0.067 — Discontinued —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 00536-1055-25 Rugby 1 tube $0.218 — Availability likely —
Differin Daily Deep Cleanser with BPO 5 g/100mL 00299-4606-00 Galderma 1 tube — — FDA listed —
Walgreens Daily Acne Cleanser- Sensitive Skin Formula 50 mg/mL 00363-5602-01 Walgreen 1 tube — — FDA listed —
Oxy Sensitive Skin Acne Cream Cleanser 50 mg/mL 10742-1004-01 The 148 ml — — FDA listed —
OXY Advanced Care Sensitive Skin Acne Cleanser 50 mg/mL 10742-1203-01 The 148 ml — — FDA listed —
OXY Sensitive Face Wash Maximum Soothing 50 mg/mLthis 10742-1313-02 The 185 ml — — FDA listed —
SPOTLESS Daily Acne Wash .05 g/mL 14222-1610-01 Rodan 1 tube — — FDA listed —
BP Wash 50 mg/g 24470-0900-04 CINTEX 113 g — — FDA listed —
REPLENIX ACNE Solution BENZOYL PEROXIDE WASH 50 mg/mL 51326-0111-01 Topiderm, 200 ml — — FDA listed —
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7300-01 Cosco 1 tube — — FDA listed —
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment Mask .05 kg/kg 52261-7301-01 Cosco 1 tube — — FDA listed —
PCA SKIN BPO Cleanser 5 g/100mL 68726-0168-04 CP 1 bottle — — FDA listed —
HUMANE Acne Wash 5 50 mg/mL 69919-0526-08 Banner 1 bottle — — FDA listed —
MEDPURA Benzoyl Peroxide 50 mg/mL 71399-9234-05 Akron 148 ml — — FDA listed —
benzoyl peroxide 5 g/100g 72162-2338-02 Bryant 142 g — — FDA listed —
BP Body Wash 50 mg/g 73318-7005-01 Skin 1 tube — — FDA listed —
Naturium Benzoyl Peroxide Cleanser 5% 50 mg/mL 76354-0123-01 e.l.f. 1 tube — — FDA listed —
5 Percent Benzoyl Peroxide Cleanser 50 mg/mL 81136-0023-01 Brand 1 tube — — FDA listed —
BENZOYL PEROXIDE 5% Topical wash 50 mg/mL 82461-0312-05 Medcore 148 ml — — FDA listed —
ACNE FORTE Acne Treatment Cream 50 mg/mL 52063-0709-00 GSCM 1 jar — — FDA listed —
SERIOUS SKINCARE Continuously Clear Clearz It 50 mg/mL 53755-0392-00 Flageoli 59 ml — — FDA listed —
Acne Treatment 50 mg/mL 67226-2050-03 Vivier 1 tube — — FDA listed —
Acne Med 5% 50 mg/mL 70707-0211-15 Face 1 bottle — — FDA listed —
MD-Acne Body Acne Treatment 50 mg/mL 71804-0230-06 MD 180 ml — — FDA listed —
HUMANE Acne Spot Treatment 50 mg/mL 73010-0127-00 Apprendista, 1 tube — — FDA listed —
Nighttime Control 50 mg/mL 76458-0333-02 Circadia 1 bottle — — FDA listed —
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 50 mg/mL 71399-9478-05 Akron 1 tube — — FDA listed —
Rugby Benzoyl Peroxide Acne Medication 50 mg/mL 50090-1720-00 A-S 1 tube — — FDA listed —
MDacne Customized Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0536-00 MDAlgorithms 1 tube — — FDA listed —
MDacne Body Acne Treatment Benzoyl Peroxide 50 mg/mL 71804-0532-00 MDAlgorithms 90 ml — — FDA listed —
Clenziderm Therapeutic 50 mg/mL 62032-0611-01 Obagi 47 ml — — FDA listed —
Face Reality 5% Advanced Acne Med 50 mg/mL 70707-0157-01 Face 1 tube — — FDA listed —
5 Acne Med 50 mg/mL 70707-0155-15 Face 1 tube — — Discontinued —
Benzoyl Peroxide Acne Medication 50 mg/mL 68071-2307-05 NuCare 42.5 ml — — FDA listed —
BLAIR and JACK Anti-Bump Acne Treatment 50 mg/mL 84377-0489-00 Blair 1 jar — — 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

🏛️
2016
On the market since
Aug 2016
📍
2026
Currently FDA-listed
10 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.

🧪 Avoiding an ingredient? See Benzoyl Peroxide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • 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 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • UNII 231H3ZT9NE
    A mild, plant-derived cleaning agent made from coconut oil. It helps solubilize and stabilize other ingredients in liquid and semi-solid formulations, acting as a surfactant and preservative booster.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • 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 D6DH1DTN7E
    Disodium laureth sulfosuccinate is a synthetic surfactant and emulsifier derived from lauryl alcohol. It helps mix oil and water-based ingredients together and is commonly used in topical formulations to improve product texture and spreadability.
  • 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 GIA7T764OD
    A silicone-based ingredient combined with polyethylene glycol. It acts as an emulsifier and surfactant to help blend oils and water-based ingredients, and reduces foaming in liquid formulations.
  • 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 M6S840WXG5
    Purslane is a plant-derived ingredient used in pharmaceuticals as a natural source of beneficial compounds. It functions as an antioxidant and anti-inflammatory agent to help stabilize the formula and support product shelf life.
  • UNII O9W3D3YF5U
    A synthetic surfactant derived from petroleum-based olefins. It helps dissolve or suspend active ingredients and other substances in liquid formulations, improving how the medicine mixes and flows.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 632GS99618
    Sodium lauroyl sarcosinate is a mild, plant-derived cleaning agent used in medicines as a surfactant and emulsifier. It helps mix oil and water-based ingredients and may aid tablet disintegration.
  • UNII R44IWB3RN5
    Soy protein is a plant-based protein derived from soybeans. It's used in medicines as a binder to hold tablet ingredients together and sometimes as a filler to add bulk and texture to 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also stateswater, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, hydrolyzed soy protein, methylparaben, PEG-8 dimethicone, portulaca oleracea extract, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

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

LabelerThe Mentholatum Company
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code10742
First marketedAug 2016
Product typeHuman Otc Drug
Portfolio108 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.

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 6 words ▾

Uses treats and helps prevent acne

⏱️ Dosage and Administration 112 words ▾

Directions wet face apply to hands then work into a lather and massage gently onto face rinse thoroughly and pat dry because excessive drying of the skin may occur, start with 1 use daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor. Sensitivity Test: Apply product sparingly to a small affected area for the first 3 days.

If no discomfort occurs, follow directions above.

⚠️ Warnings 133 words ▾

Warnings For external use only Do not use if you have very sensitive skin are sensitive to benzoyl peroxide When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.

Irritation may be reduced by using this product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe If pregnant or breast-feeding ask a health professional before use.

📦 Storage and Handling 20 words ▾

Other information THIS PRODUCT MAY BLEACH HAIR OR DYED FABRICS KEEP TIGHTLY CLOSED avoid storing at temperatures above 100°F (38°C)

🧪 Active Ingredient 5 words ▾

Active ingredient Benzoyl peroxide 5%

🧪 Inactive Ingredients 39 words ▾

Inactive ingredients water, cetostearyl alcohol, sodium C14-16 olefin sulfonate, disodium laureth sulfosuccinate, capryl/capramidopropyl betaine, xanthan gum, butylene glycol, citric acid, diazolidinyl urea, hydrolyzed soy protein, methylparaben, PEG-8 dimethicone, portulaca oleracea extract, propylparaben, sodium citrate, sodium hydroxide, sodium lauroyl sarcosinate

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 Do Not Use 14 words ▾

Do not use if you have very sensitive skin are sensitive to benzoyl peroxide

📄 When Using This Product 94 words ▾

When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using this product less frequently or in a lower concentration.

📄 Stop Use and Ask a Doctor If 10 words ▾

Stop use and ask a doctor if irritation becomes severe

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding ask a health professional before use.

📄 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.

📄 Questions or Comments 7 words ▾

Questions? 1-877-636-2677 MON-FRI 9 AM-5 PM (EST)

📄 Package Label / Principal Display Panel 6 words ▾

Principal Display Panel Oxy Sensitive Skin

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

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Epsolay (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Epsolay. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$60.9K
Claims incl. refills
82
Beneficiaries
63
Spend / beneficiary
$967.04
Spend / claim
$742.97
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OXY Sensitive Face Wash Maximum Soothing (this brand).

Top reported reactions

Rash92
Erythema70
Pruritus69
Pain65
Fatigue63
Nausea62
Anxiety60

Age at onset

Neonate1
Child2
Adolescent29
Adult146
Elderly22

Reporter sex

1,319 reports
Male · 40%
Female · 59%
Unknown · 1%

Serious outcomes

Hospitalization274
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 162 62
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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 The Mentholatum Company. 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 1 other package presentation of this same product, including 148 ml (10742-1313-01). 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?
The Mentholatum Company 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.
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.