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ageLOC LumiSpa Treatment Cleanser Acne Salicylic Acid 5 mg/mL Lotion, 100 mL — NDC 62839-1495-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ageLOC LumiSpa Treatment Cleanser Acne Salicylic Acid 5 mg/mL Lotion, 100 mL — NDC 62839-1495-1 (Billing 62839-1495-01)

by NSE Products, Inc · 100 mL in 1 TUBE

This is a package of 100 mL of ageLOC LumiSpa Treatment Cleanser Acne Salicylic Acid 5 mg/mL Lotion from NSE Products, Inc, marketed since Oct 2017 and currently FDA-listed. It is this product's only package size.

NDC 62839-1495-01
🏷️ FDA NDC (as labeled) 62839-1495-1 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 62839-1495-1
Product NDC 62839-1495
11-digit billing NDC 62839149501
RxCUI 865105
UNII O414PZ4LPZ
Application # M006
SPL Set ID 7f478ae8-8b97-4cdf-a023-cea14b992ff9
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-10-01
Route TOPICAL
Dosage form LOTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 865105
Why two NDCs? The FDA registers this code as 62839-1495-1 — 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 → 62839-1495-01. 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 Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or b...

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical 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 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
62839-1495-01 You're viewing this Main listing 100 mL in 1 TUBE 2017-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ultra Clear Foaming Cleanser .5 g/100mL 10028-0050-01 ULTRACEUTICALS 150 ml — — FDA listed —
UNBLEMISH Refining Acne Wash .005 g/mL 14222-2111-01 Rodan 1 tube — — FDA listed —
Meijer Foaming Cleanser Acne medication 5 mg/mL 41250-0354-01 Meijer 177 ml — — FDA listed —
Deep Cleaning Astringent 5 mg/mL 41250-0775-34 Meijer, 237 ml — — Discontinued —
Vichy Laboratoires Normaderm Daily Gentle Cleanser 5 mg/mL 49967-0232-01 L'Oreal 125 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Daily Deep Cleansing 5 mg/mL 49967-0307-01 L'Oreal 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 49967-0630-01 L'Oreal 200 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/mL 54111-0171-02 Bentley 1 tube — — FDA listed —
Purifying Clay Mask .5 g/100mL 56152-5012-01 Cosmetic 88 ml — — FDA listed —
ageLOC LumiSpa Treatment Cleanser Acne 5 mg/mLthis 62839-1495-01 NSE 100 ml — — FDA listed —
Clear Smart Charcoal Blackhead Scrub .5 g/100mL 68828-0001-01 Distribuidora 1 tube — — FDA listed —
Cln Acne Cleanser 5 mg/mL 69530-0857-46 TopMD 100 ml — — FDA listed —
Vichy Laboratoires Normaderm Phytoaction Deep Cleansing 5 mg/mL 69625-0306-01 COSMETIQUE 200 ml — — FDA listed —
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne Treatment 5 mg/mL 69625-0630-01 COSMETIQUE 200 ml — — FDA listed —
Skinpharmacy Advanced Acne Therapy Pore Refining Facial Mask 5 mg/mL 69842-0077-01 CVS 1 tube — — FDA listed —
Aveeno CLEAR COMPLEXION foaming cleanser 5 mg/mL 69968-0471-06 Kenvue 177 ml — — FDA listed —
Neutrogena deep clean purifying cooling gel scrub 5 mg/g 69968-0740-04 Kenvue 119 g — — FDA listed —
Aveeno Positively Radiant Clear Complexion Foaming Cleanser 5 mg/mL 69968-0769-06 Kenvue 177 ml — — FDA listed —
Clarifying Cleanser .5 g/100mL 70381-0128-02 Murad, 1 tube — — FDA listed —
So Totally Clean Deep Pore Cleanser .5 g/100mL 70626-0104-21 ASPIRE 200 ml — — FDA listed —
Clean Getaway Bag 70626-0504-54 ASPIRE 1 kit — — FDA listed —
MDacne Customized Acne Cleanser Hydrating Salicylic Acid 5 mg/mL 71804-0534-00 MDAlgorithms 59 ml — — FDA listed —
Salicylic Acid Cleanser 5 mg/g 73318-7001-02 Skin 1 bottle — — FDA listed —
Even and Clear Cleanser 5 mg/mL 73453-0003-01 Ambi 177 ml — — FDA listed —
Peach and Lily Peaches Slices Acne Oil Acne Free Moisturizer 5 mg/mL 81515-0502-01 Peach 80 ml — — FDA listed —
Caring Mill Acne Clearing Cleanser .5 g/100mL 81522-0100-01 FSA 250 ml — — FDA listed —
Derma Pella Acne Wash for Oily Skin 5 mg/mL 82160-0764-01 Pella 150 ml — — Discontinued —
Creamy Foam Cleanser .5 g/100mL 82870-0002-01 Dime 120 ml — — FDA listed —
Freshiny Facial Cleanser Acne Treatment 5 mg/g 84544-0001-01 Guangdong 1 tube — — FDA listed —
Acne Advanced Clarifying Masque 5 mg/mL 15751-3020-02 Eminence 1 tube — — FDA listed —
enfuselle Acne Clarifying 5 mg/mL 59899-0002-01 Shaklee 1 tube — — FDA listed —
Acne Fighting Foundation Caramel 5 mg/mL 70412-0435-01 Zhejiang 1 bottle — — FDA listed —
CLARIFAST One Step Acne Treatment 5 mg/mL 82908-0358-00 VIREO 81.33 ml — — FDA listed —
ClearSynergy 5 mg/mL 71617-0102-01 SRL 150 ml — — FDA listed —
Aveeno Positively Radiant Clear Complexion Daily Moisturizer 5 mg/mL 69968-0928-04 Kenvue 1 bottle — — FDA listed —
Clean and Clear Essentials Dual Action Moisturizer 5 mg/mL 69968-0803-04 Kenvue 118 ml — — FDA listed —
Neutrogena Oil Free Acne Moisturizer Pink Grapefruit 5 mg/mL 69968-0193-01 Kenvue 14 ml — — FDA listed —
Target Up and Up Moisturizer with Salicylic Acid Acne Treatment 5 mg/mL 82442-0016-13 TARGET 118 ml — — FDA listed —
Cetaphil Gentle Clear Mattifying Acne Moisturizer 5 mg/mL 00299-4117-00 Galderma 1 tube — — FDA listed —
Neutrogena Stubborn Blackheads Daily Serum 5 mg/mL 69968-0703-01 Kenvue 1 tube — — FDA listed —
Dapinaq 5 mg/mL 87110-0002-01 METHODIQ 1 bottle — — FDA listed —
Azelaq 5 mg/mL 87110-0003-01 METHODIQ 1 bottle — — FDA listed —
Yes To Tomatoes Detoxifying Charcoal Sleeping Mask 5 mg/mL 69840-0008-08 Yes 4 ml — — FDA listed —
Neutrogena Evenly Clear Acne Exfoliant 5 mg/mL 69968-0944-01 Kenvue 1 bottle — — FDA listed —
Aveeno clear complexion daily moisturizer 5 mg/mL 69968-0372-04 Kenvue 1 bottle — — FDA listed —
Aveeno Positively Radiant Clear Complexion Daily Moisturizer 5 mg/mL 69968-0738-04 Kenvue 1 bottle — — FDA listed —
PuraClear Advanced Skincare Acne Moisturizer 5 mg/mL 88016-0017-00 PuraClear 118 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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 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 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 E00JL9G9K0
    A plant-derived cleaning agent made from coconut oil and natural sugars. It works as a solubilizer and emulsifier to help mix water and oil-based ingredients together in the medicine.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII 8HO6PVN24W
    Carnosine is a naturally occurring compound made from two amino acids. In medicines, it may serve as a buffer to help maintain the product's pH stability.
  • 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 5OCF3O11KX
    A plant-derived surfactant made from coconut oil. It helps mix oil and water ingredients together in the formulation and can improve how the medicine spreads or feels on the skin.
  • UNII 8NLQ36F6MM
    Edetate disodium anhydrous is a chemical compound that binds to metal ions in a medicine. It's used as a stabilizer to prevent unwanted chemical reactions and help keep the drug product effective during storage.
  • UNII 08H094218D
    A plant extract from the flowering tops of narrow-leaf willowherb. It's used as a natural flavor and botanical ingredient to add taste and plant-derived components to the medicine.
  • 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 K17762966S
    A natural plant extract from the narcissus bulb used as a flavoring or fragrance ingredient in some medicines. It may help improve taste or smell of the product.
  • 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 HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7N2B70SFEZ
    Rice germ is the nutrient-rich inner layer of the rice grain. It's used in medicines as a filler and bulking agent to add volume and help bind ingredients together in tablets and capsules.
  • UNII ABS794681C
    A plant extract from schisandra berries used in traditional medicine. It may be included as a natural flavoring agent or for its potential antioxidant properties in the formulation.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • 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 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.

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

The official label also statesWater (Aqua), Cetearyl Alcohol, Glycerin, PEG-8 Dimethicone, Cocamidopropyl Betaine, Caprylyl/Capryl Glucoside, Capryl/Capramidopropyl Betaine, Carbomer, Narcissus Tazetta Bulb Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Schizandra Chinensis Fruit Extract, Xanthan Gum, Carnosine, Oryza Sativa (Rice) Extract, Disodium EDTA, Phenoxyethanol, Hydroxyacetophenone, Sodium Hydroxide, Sodium Chloride.

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

LabelerNSE Products, Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code62839
First marketedOct 2017
Product typeHuman Otc Drug
Portfolio5 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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses For the treatment of acne. Penetrates pores to eliminate most acne blemishes.

⏱️ Dosage and Administration 69 words ▾

Directions clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

⚠️ Warnings 65 words ▾

Warnings For external use only. 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 unless directed by a doctor. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid (0.5%)

🧪 Inactive Ingredients 43 words ▾

Inactive Ingredients Water (Aqua), Cetearyl Alcohol, Glycerin, PEG-8 Dimethicone, Cocamidopropyl Betaine, Caprylyl/Capryl Glucoside, Capryl/Capramidopropyl Betaine, Carbomer, Narcissus Tazetta Bulb Extract, Epilobium Angustifolium Flower/Leaf/Stem Extract, Schizandra Chinensis Fruit Extract, Xanthan Gum, Carnosine, Oryza Sativa (Rice) Extract, Disodium EDTA, Phenoxyethanol, Hydroxyacetophenone, Sodium Hydroxide, Sodium Chloride.

🎯 Purpose 3 words ▾

Purpose Acne treatment

📄 When Using This Product 54 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 unless directed by a doctor. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Questions or Comments 2 words ▾

Questions? 1-800-487-1000

📄 Package Label / Principal Display Panel 32 words ▾

PRINCIPAL DISPLAY PANEL - 100 mL Tube Label NU SKIN ® ageLOC ® LumiSpa ® TREATMENT CLEANSER acne 100 mL ℮

3.4 Fl Oz PRINCIPAL DISPLAY PANEL - 100 mL Tube Label

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 Salicylic Acid (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Salicylic Acid. 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
$11.2K
Claims incl. refills
43
Beneficiaries
35
Spend / beneficiary
$319.01
Spend / claim
$259.66
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 ageLOC LumiSpa Treatment Cleanser Acne (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

1,852 reports

Serious outcomes

Death611
Life-threatening174
Disabling124
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 252 93
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 NSE Products, Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NSE 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.
← 62839-1339-01 · NSE 62839-1554-01 · NSE →
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.