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PHARMA CLEAR SPOT TREATMENT SALICYLIC ACID 2 g/100mL Liquid — NDC 67879-104-51 (Billing 67879-0104-51)

by PHARMAGEL INTERNATIONAL INC · 1 TUBE in 1 BOX / 15 mL in 1 TUBE

This is a package of PHARMA CLEAR SPOT TREATMENT SALICYLIC ACID 2 g/100mL Liquid from PHARMAGEL INTERNATIONAL INC, marketed since Jun 2016 and currently FDA-listed. It is this product's only package size.

NDC 67879-0104-51
🏷️ FDA NDC (as labeled) 67879-104-51 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 67879-104-51 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67879 labeler · 104 product · 51 package
Package marketed since
Jun 15, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6787910451 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 67879-104-51
Product NDC 67879-104
11-digit billing NDC 67879010451
RxCUI 251577
UNII O414PZ4LPZ
Application # M006
SPL Set ID 24736409-b500-4aae-857e-1f4fb1760a15
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-15
Route TOPICAL
Dosage form LIQUID
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 251577
Why two NDCs? The FDA registers this code as 67879-104-51 — 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 → 67879-0104-51. 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 mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
67879-0104-51 You're viewing this Main listing 1 TUBE in 1 BOX / 15 mL in 1 TUBE 2016-06-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PanOxyl Clarifying Exfoliant 2 g/100mL 00316-0296-04 Crown 118 ml — — FDA listed —
Hero Pore Release Blackhead Clearing 20 mg/mL 10237-0001-00 Church 100 ml — — FDA listed —
Sulfur 8 Anti-Dandruff Braid 20 mg/mL 12022-0021-00 J. 356 ml — — FDA listed —
Sulfur 8 Fresh Anti-Dandruff 20 mg/mL 12022-0028-00 J. 355 ml — — FDA listed —
Kiehls Since 1851 Dermatologist Solutions Truly Targeted Acne Clearing Solution 20 mg/mL 49967-0055-01 L'Oreal 1 bottle — — FDA listed —
Thayers Since 1847 Natural Remedies Double Action Acne Serum 20 mg/mL 49967-0062-01 L'Oreal 1 bottle — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Toner 20 mg/mL 49967-0523-01 L'Oreal 355 ml — — FDA listed —
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment 20 mg/mL 51150-0995-01 SICOS 1 bottle — — FDA listed —
Dr. Gross AB Acne Daily Breakout 20 mg/mL 51326-0179-01 Topiderm, 1 bottle — — FDA listed —
Clear Proof Blemish Control Toner Acne Medication 2 g/100mL 51531-6743-05 Mary 1 bottle — — FDA listed —
Anti-Everything Face Serum 2 g/100mL 54111-0180-01 Bentley 1 bottle — — FDA listed —
Emuaid 2 g/100mL 55926-0029-01 Speer 30 ml — — FDA listed —
Exuviance Daily Acne Peel 20 mg/mL 58414-0017-02 NeoStrata 1 bottle — — FDA listed —
Atrix Clarifying Toner 20 mg/mL 59088-0444-08 PureTek 118 ml — — FDA listed —
Acne Warrior Clearing Astringent 2 g/100mL 61197-0121-00 Pacifica 236 ml — — FDA listed —
Clenziderm Pore Therapy Acne Treatment 20 mg/mL 62032-0612-04 Obagi 148 ml — — FDA listed —
Acne Oil Control Primer 20 mg/g 62742-4211-02 Allure 1 tube — — FDA listed —
Shea Moisture 2 g/100mL 64942-2355-02 Conopco 1 bottle — — FDA listed —
Jack Black Bump Fix 20 g/1000g 66738-0022-01 Jack 183 g — — FDA listed —
Pharma Clear Spot Treatment 2 g/100mLthis 67879-0104-51 PHARMAGEL 1 tube — — FDA listed —
AGE Bright Clearing Serum 20 mg/mL 68479-0184-00 Dermalogica, 3 ml — — FDA listed —
Breakout Clearing Booster 2 mg/100mL 68479-0772-00 Dermalogica, 2 ml — — FDA listed —
Breakout Clearing Booster 2 g/100mL 68479-0773-02 Dermalogica, 1 bottle — — FDA listed —
Neutrogena Clear Pore Oil-Eliminating Astringent 20 mg/mL 69968-0028-08 Kenvue 236 ml — — FDA listed —
Clean and Clear Essentials Deep Cleaning Astringent 20 mg/mL 69968-0209-08 Kenvue 240 ml — — FDA listed —
Neutrogena Oil Free Acne Stress Control Triple Action Toner 20 mg/mL 69968-0521-08 Kenvue 237 ml — — FDA listed —
Clean and Clear Essentials Acne Toner 20 mg/mL 69968-0820-08 Kenvue 240 ml — — FDA listed —
Neutrogena Oil Free Acne Stress Control Triple Action Toner 20 mg/mL 69968-0925-08 Kenvue 236 ml — — FDA listed —
Acne Spot Treatment 20 mg/mL 70060-1505-01 CosMedical 9 ml — — FDA listed —
e.l.f Plz Clarify Facial Oil 2 g/100mL 70412-0401-01 Zhejiang 30 ml — — FDA listed —
Exfo Tonic Acne Treatment 2 g/100mL 70764-0104-51 CONTROL 1 bottle — — FDA listed —
L BRI Pure n Natural Deep Clean Toner 20 mg/mL 71238-0218-00 L'BRI 188 ml — — FDA listed —
Viaderma Clear Acne Treatment 20 mg/mL 71262-0017-15 VIADERMA 1 bottle — — FDA listed —
Detox Drops Acne Toner 2 g/100mL 71499-0523-01 KENDO 1 bottle — — FDA listed —
FHF Day Breakthru 2 g/100g 72788-0142-11 Summer 1 bottle — — FDA listed —
Dr Throwers Oily Skin Facial Astringent 2 g/100g 72839-0611-02 Derma 57 g — — FDA listed —
Pore Refining Toner 2 g/100g 72957-0013-01 Private 195 g — — FDA listed —
Sunday Riley Peacekeeper Acne Treatment Serum 20 mg/mL 73001-0505-01 Sunday 1 pouch — — FDA listed —
Naturium Salicylic Acid Serum 2% 20 mg/mL 76354-0122-01 e.l.f. 1 bottle — — FDA listed —
e.l.f. PLZ Clarify Facial Oil 20 mg/mL 76354-0419-01 e.l.f. 1 bottle — — FDA listed —
The Inkey List 360 Acne Clearing Serum 20 mg/mL 81136-0028-01 Brand 1 bottle — — FDA listed —
Mara Clear Skin Mineral Milk Acne Treatment 20 mg/mL 81461-0002-00 Mara 30 ml — — FDA listed —
Dermeleve Scalp Psoriasis Treatment 2 g/100mL 81507-0006-01 Advanced 1 bottle — — FDA listed —
Peach and Lily Peaches Slices Acne Exfoliating toner 20 mg/mL 81515-0501-01 Peach 120 ml — — FDA listed —
Skinlycious Glow Exfoliant 2 g/100mL 81574-0001-01 Skinlycious 28 ml — — FDA listed —
CeraVe Developed with Dermatologists BHA Exfoliating Toner Acne Treatment 20 mg/mL 82046-0291-01 L'Oreal 237 ml — — FDA listed —
Lancome Paris Clarifique BX-Interceptor Topical Acne Clearing Treatment 20 mg/mL 82046-0955-01 LOreal 1 bottle — — FDA listed —
Clarifying Toner 2 g/100mL 83286-0012-01 Drmtlgy, 189 ml — — FDA listed —
Bubble Super Clear Blemish Prevention Serum 20 mg/mL 83509-0001-01 BUBBLE 1 bottle — — FDA listed —
Doing The Work Salicylic Acid Acne Treatment 20 mg/mL 84234-0001-00 Personal 1 bottle — — FDA listed —
Personal Day Doing the Work Daily Exfoliating Treatment 20 mg/mL 84234-0002-00 Personal 1 bottle — — FDA listed —
Perricone MD Acne Relief Gentle Exfoliating Toner Salicylic Acid Acne Treatment 2 g/100mL 84448-0602-18 THG 1 bottle — — FDA listed —
AHA BHA Blemish Control and Exfoliating Serum 2 g/100mL 85439-0101-01 Banuskin, 30 ml — — FDA listed —
PHOFAY Salicylic Acid Acne Treatment Essence 20 mg/mL 87080-0001-00 Hangzhou 1 bottle — — FDA listed —
Home Health Psoriasis Medicated Scalp and Body Wash 2 g/100mL 76020-0300-08 Home 236 ml — — FDA listed —
PAPATUI Acne Fighting Facial Cleanser 2 g/100mL 83850-0210-00 PAPATUI, 237 ml — — FDA listed —
Tula Skincare Keep It Clear Acne Foam Cleanser 2 g/100mL 84126-0237-18 The 1 bottle — — FDA listed —
Stridex XL Face and Body Pads 2 g/100mL 10157-2114-01 Blistex 1 jar — — FDA listed —
Proactiv CLEAR ZONE BODY PADS 2 g/100mL 11410-0056-00 Alchemee, 75 applicators — — FDA listed —
Acne Defense Face Wash 2 g/100mL 61197-0120-00 Pacifica 172 ml — — FDA listed —
Biore Witch Hazel Pore Clarifying Cleanser 2 g/100mL 10596-0188-67 Kao 200 ml — — FDA listed —
Acne Warrior Body Wash 2 g/100mL 61197-0123-34 Pacifica 355 ml — — FDA listed —
Max Complexion Correction Pads 2 g/100mL 54031-0501-22 PETER 60 patches — — FDA listed —
Pharma Clear Acne Treatment 2 g/100mL 67879-0102-51 PHARMAGEL 1 tube — — FDA listed —
YOUR Anti-Acne Body Wash 2 g/100mL 84229-0018-01 Skin 300 ml — — FDA listed —
Quick Action 2 g/100mL 49035-0934-83 Walmart 200 ml — — FDA listed —
Proactiv Acne Body Wash 2 g/100mL 11410-0074-00 Alchemee, 1 tube — — FDA listed —
Stridex Maximum 2 g/100mL 10157-1006-01 Blistex 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
Jun 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 Salicylic Acid Topical 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 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 LU49E6626Q
    A synthetic organic compound used as a pH buffer and neutralizing agent in medicines. It helps maintain the proper acidity level in liquid formulations to improve stability and comfort.
  • UNII D9C330MD8B
    Copovidone is a synthetic polymer made by combining two types of plastic-like molecules. It acts as a binder and film-former to help hold tablet ingredients together and improve how the medicine dissolves in your body.
  • UNII 72MF9C2A18
    A silicone-based chemical that combines dimethicone (a water-repelling oil) with a polyethylene glycol chain. It works as an emulsifier and surfactant to help mix oil and water components and reduce foam in liquid medicines.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII QU52J3A5B3
    A plant extract from black willow bark used as a natural flavoring agent and to add medicinal plant material to the formulation. It may also help preserve the product.
  • 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.

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

The official label also statesWATER (AQUA), ALCOHOL DENAT, DIMETHICONE PEG-8 MEADOWFOAMATE, AMINOMETHYL PROPANOL, PVM/MA DECADIENE CROSSPOLYMER, TRICLOSAN, SALIX NIGRA (WILLOW) BARK EXTRACT, DISODIUM EDTA

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

LabelerPHARMAGEL INTERNATIONAL INC
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code67879
First marketedJun 2016
Product typeHuman Otc Drug
Portfolio7 products on file

More NDCs from PHARMAGEL INTERNATIONAL INC labeler code 67879

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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses Use for treatment of acne and to decrease bacteria on the skin.

⏱️ Dosage and Administration 22 words ▾

DIRECTIONS: Apply sparingly to blemishes after cleansing. Allow to penetrate and dry before applying other preparations. For best results, use twice daily.

⚠️ Warnings 5 words ▾

WARNINGS For external use only

🧪 Active Ingredient 5 words ▾

ACTIVE INGREDIENTS Salicylic Acid 2.0%

🧪 Inactive Ingredients 22 words ▾

INACTIVE INGREDIENTS: WATER (AQUA), ALCOHOL DENAT, DIMETHICONE PEG-8 MEADOWFOAMATE, AMINOMETHYL PROPANOL, PVM/MA DECADIENE CROSSPOLYMER, TRICLOSAN, SALIX NIGRA (WILLOW) BARK EXTRACT, DISODIUM EDTA

🎯 Purpose 3 words ▾

PURPOSE Acne Medication

📄 When Using This Product 67 words ▾

When using this product: • avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. • Limit use to the face and neck.

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Package Label / Principal Display Panel 1 words ▾

PHK_1B_RL-1_box_final

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 PHARMA CLEAR SPOT TREATMENT (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Age at onset

Neonate7
Infant1
Child8
Adolescent5
Adult170
Elderly94

Reporter sex

0 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Death611
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 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 — Not published for this NDC No photo available yet for this listing.
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 PHARMAGEL INTERNATIONAL INC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PHARMAGEL INTERNATIONAL 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.
← 67879-0103-11 · PHARMAGEL 67879-0304-51 · PHARMAGEL →
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.