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ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL Cloth — NDC 76446-022-50 (Billing 76446-0022-50)

by Anna Lotan Ltd. · 50 PACKAGE in 1 JAR / 2 mL in 1 PACKAGE

This is a package of ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mL Cloth from Anna Lotan Ltd., marketed since Apr 2026 and currently FDA-listed. It is this product's only package size.

NDC 76446-0022-50
🏷️ FDA NDC (as labeled) 76446-022-50 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 →

NDC database record

One package, one record: these facts belong to NDC 76446-022-50 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
76446 labeler · 022 product · 50 package
Package marketed since
Apr 7, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850034338637
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 76446-022-50
Product NDC 76446-022
11-digit billing NDC 76446002250
RxCUI 797892
UNII O414PZ4LPZ
UPC 0850034338637
Application # M006
SPL Set ID 2b57da0c-889b-41c3-9aca-c60ef49b7603
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-04-07
Route TOPICAL
Dosage form CLOTH
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 797892
Why two NDCs? The FDA registers this code as 76446-022-50 — 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 → 76446-0022-50. 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 →
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 eachPer 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
76446-0022-50 You're viewing this Main listing 50 PACKAGE in 1 JAR / 2 mL in 1 PACKAGE 2026-04-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Stridex Maximum 2 g/100mL 10157-1006-01 Blistex 1 jar — — FDA listed —
Stridex XL Face and Body Pads 2 g/100mL 10157-2114-01 Blistex 1 jar — — FDA listed —
OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADS 20 mg 10742-1000-01 The 90 swabs — — FDA listed —
Oxy Deep Pore Acne Cleansing Pads 20 mg 10742-1006-01 The 90 cloths — — FDA listed —
Oxy 3-IN-1 Acne Cleansing Pads 20 mg 10742-1008-01 The 90 cloths — — FDA listed —
Oxy 3-IN-1 Acne Cleansing Pads 20 mg 10742-1010-01 The 90 fors — — FDA listed —
Oxy Deep Pore Acne Cleansing Pads 20 mg 10742-1011-01 The 90 fors — — FDA listed —
OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADS 20 mg 10742-1200-01 The 90 swabs — — FDA listed —
OXY Deep Pore Cleansing Pads 20 mg 10742-4204-01 The 90 swabs — — FDA listed —
OXY 3 in 1 Acne Pads 20 mg 10742-4359-01 The 90 swabs — — FDA listed —
Proactiv CLEAR ZONE BODY PADS 2 g/100mL 11410-0056-00 Alchemee, 75 applicators — — FDA listed —
ZO Skin Health Oil Control Pads Acne Treatment 20 mg/mL 42851-0085-30 ZO 30 patches — — FDA listed —
Thayers Since 1847 Natural Remedies Blemish Clearing Witch Hazel Aloe Vera Formula Pads 20 mg/mL 49967-0705-01 L'Oreal 60 applicators — — FDA listed —
Gly-Sal 5-2 Pads .02 g 51326-0038-60 Topiderm, 60 cloths — — FDA listed —
Gly-Sal 10-2 Pads .02 g 51326-0039-60 Topiderm, 60 cloths — — FDA listed —
Gly-Sal 10-2 20 mg 51326-0712-60 Topiderm, 60 cloths — — FDA listed —
Gly-Sal 2-2 Pads 20 mg 51326-0923-01 Topiderm, 60 cloths — — FDA listed —
Max Complexion Correction Pads 2 g/100mL 54031-0501-22 PETER 60 patches — — FDA listed —
Equate Beauty Quick Action Pads Salicylic Acid Acne Treatment 20 mg/mL 61805-0117-01 Bath 90 patches — — FDA listed —
DermaClear Pads 20 mg/g 62742-4076-02 Allure 1 jar — — FDA listed —
Universal Clarifying Pad 20 mg/g 62742-4276-02 Allure 1 jar — — FDA listed —
Clearasil Rapid Rescue Deep Treatment Pads .02 g 63824-0431-90 Reckitt 90 cloths — — FDA listed —
Noxzema ANTIBLEMISH .02 g/g 64942-1259-01 Conopco 0284 g — — FDA listed —
Rush Salicylc Acid Complexion Pads 2 g/100g 65113-1201-01 G.S. 1 jar — — FDA listed —
Anti-Aging Blemish Control Peel Pads 2.366 g/118.29g 65278-0318-01 June 118.29 g — — FDA listed —
Neutrogena Rapid Clear Treatment Pads 20 mg 69968-0719-06 Kenvue 60 cloths — — FDA listed —
Retexturizing Body Pads 2 g/100mm 70381-0126-02 Murad, 1 jar — — FDA listed —
Cleansing Wipes 2 g/100mL 71613-0001-01 Nextcell 25 applicators — — FDA listed —
FHF Change Peel Pads 2 g/100g 72788-0183-02 Summer 1 bottle — — FDA listed —
Acne Correction Pads 2 g/100mL 72957-0012-01 Private 1 jar — — FDA listed —
AHA/BHA Swipes 2 g/100mL 73318-7004-06 SKIN 1 jar — — FDA listed —
ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid 2 g/100mLthis 76446-0022-50 Anna 1 jar — — FDA listed —
anna lotan PURIFYING PADS with 2% Salicylic Acid 2 g/100mL 76446-0039-50 Anna 1 jar — — Discontinued —
Equate 2% Salicylic acid Acne treatment pad 2 g/100g 79903-0062-01 Walmart, 165 g — — FDA listed —
Maximum Sterngth Cleansing Pads Equate 2 g 79903-0207-01 Walmart 1 jar — — FDA listed —
Tingl Exfoliating Pads 2 g/100g 83286-0011-01 Drmtlgy, 60 patches — — FDA listed —
Crystal Clear Acne Treatment Pads 2 g/100mL 83316-0001-01 Skin 60 patches — — Discontinued —
First Aid Beauty Acne Clearing Pads 2 g/100mL 84126-0119-60 The 60 patches — — FDA listed —
Tula Skincare Breakout Breakthrough Acne Toner Pads 2 g/1001 84126-0152-30 The 1 jar — — FDA listed —
Acne Treatment Cotton Pads 2 g/100g 84356-0003-01 Guangzhou 100 g — — FDA listed —
Societe Clear Skin Pads 2 g/100g 87700-0147-02 Societe 1 jar — — FDA listed —
Oxygenetix Oxygenating Foundation Acne Control 2 g/100mL 10258-0101-11 COLONIAL 15 ml — — Discontinued —
Spot Stopper Acne Spot Treatment 2 g/100mL 69366-0412-32 The 1 tube — — FDA listed —
Pert 2 in 1 Advanced plus 2 g/100mL 81277-0802-13 Sodalis 400 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 43479-0112-51 KATE 1 bottle — — FDA listed —
Acne Control Face Wash 2 g/100mL 54111-0185-01 Bentley 180 ml — — FDA listed —
Salicylic Wash 2 g/100mL 70764-0102-56 CONTROL 1 bottle — — FDA listed —
Acne Spot Treatment 2 g/100mL 70764-0105-51 CONTROL 1 bottle — — FDA listed —
Multi-Action Clear - Acne Clearing Treatment 2% Salicylic Acid 2 g/100mL 76147-0301-07 StriVectin 1 tube — — FDA listed —
PanOxyl Acne Gel Wash 2 g/100mL 00316-0299-01 Crown 192 ml — — FDA listed —
PCA Gel 2 g/100mL 68726-0445-02 CP 1 bottle — — FDA listed —
First Aid Beauty FAB Acne Spot Treatment 2 g/100mL 69423-0724-22 The 1 tube — — FDA listed —
SEYTU Spot 2 g/100mL 84271-0002-00 Omnilife 1 tube — — FDA listed —
Pharma Clear Cleanser 2 g/100mL 67879-0101-11 PHARMAGEL 175 ml — — FDA listed —
Start So Fresh 2 g/100mL 70626-0105-13 ASPIRE 100 ml — — FDA listed —
Treat So Deep Acne-Fighting Treatment 2 g/100mL 70626-0106-15 ASPIRE 1 tube — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 82730-0100-05 Good 148 ml — — FDA listed —
Acne Toner Serum 2 g/100mL 82870-0003-01 Dime 60 ml — — FDA listed —
Acne Spot Treatment 2 g/100mL 82870-0006-01 Dime 15 ml — — FDA listed —
Acne Control Superclean Body Wash AHA BHA Formula 2 g/100mL 54111-0170-50 Bentley 250 ml — — FDA listed —
Tula Skincare Clear It Up Acne Clearing and Tone Correcting Gel 2 g/100mL 84126-0121-15 The 1 tube — — FDA listed —
Tula Skincare Breakout Star Lightweight Acne Moisturizer 2 g/100mL 84126-0229-15 The 15 ml — — FDA listed —
Perricone MD Acne Relief Maximum Strength Clearing Treatment 2 g/100mL 84448-0301-59 THG 1 bottle — — FDA listed —
Perricone MD Acne Relief Gentle and Soothing Cleanser 2 g/100mL 84448-0539-17 THG 1 tube — — FDA listed —
Clearasil Stubborn Acne Control 5in1 Exfoliating Wash 2 g/100mL 63824-0436-01 Reckitt 200 ml — — FDA listed —
ELF Blemish Control Face Primer Clear 2 g/100mL 76354-0210-10 e.l.f. 30 ml — — FDA listed —
Curology Acne-Clearing Gel Serum 2 g/100mL 82575-0500-00 Curology, 1 tube — — FDA listed —
Perricone MD Acne Relief Calming and Soothing Clay Mask 2 g/100mL 84448-0955-10 THG 10 ml — — FDA listed —
Proactiv Deep Cleansing Wash 2 g/100mL 11410-0048-05 THE 1 bottle — — FDA listed —
Good Molecules Acne Foaming Cleanser 2 g/100mL 64412-1005-02 Twincraft 1 bottle — — FDA listed —
ELF Clear Blemish Control Face Primer 2 g/100mL 76354-0624-01 e.l.f. 14 ml — — FDA listed —
Ultra Clear Treatment 2 g/100mL 10028-0051-01 ULTRACEUTICALS 50 ml — — FDA listed —
Clear System Clarifying Gel Cleanser 2 g/100mL 54111-0189-20 Bentley 20 ml — — FDA listed —
Clarifying Peel 2 g/100mL 46007-0102-11 Skin 20 ml — — Discontinued —
Acne Control Body Wash 2 g/100mL 54111-0184-01 Bentley 250 ml — — FDA listed —
Clear Exfoliating Solution Paulas Choice 2 g/100mL 56152-5002-01 Cosmetic 118 ml — — FDA listed —
Bha Cleanser 2% 2 g/100mL 61328-0403-01 Skinfix, 30 ml — — FDA listed —
Eradikate Acne Mark Fading 2 g/100mL 72204-0903-02 Rare 1 bottle — — FDA listed —
Triderma Psoriasis Control Body Wash 2 g/100mL 10738-0217-63 Genuine 473 ml — — FDA listed —
Proactivplus Pore Clearing Treatment 2 g/100mL 11410-0047-30 Alchemee, 1 tube — — FDA listed —
First Aid Beauty FAB Pharma White Clay Acne Treatment 2 g/100mL 69423-0555-60 The 60 patches — — FDA listed —
Good Molecules Maximum Strength Acne Gel Cream 2 g/100mL 82730-0102-01 Good 1 tube — — FDA listed —
Dry It Out Acne Spot Treatment 2 g/100mL 61197-0122-00 Pacifica 29 ml — — FDA listed —
Acne Spot Treatment 2% Bha 2 g/100mL 61328-0404-05 Skinfix, 15 ml — — FDA listed —
Clearasil Rapid Rescue Deep Treatment Wash 2 g/100mL 63824-0432-01 Reckitt 200 ml — — FDA listed —
Good Molecule Maximum Strenght Acne 2 g/100mL 68577-0287-00 COSMAX 1 tube — — FDA listed —
ORLASKIN ACNE Treatment 2 g/100mL 87582-0005-01 Guangzhou 50 ml — — FDA listed —
SUZANOBAGIMD Acne Cleansing Wipes 2 g/100mL 62032-0617-25 Obagi 25 patches — — FDA listed —
Bliss Care Acne Treatment Gel 2 g/100mL 83566-0627-01 Guangdong 10 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

🏛️
2026
On the market since
Apr 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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

LabelerAnna Lotan Ltd.
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code76446
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio2 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 7 words ▾

Uses • For the treatment of acne.

⏱️ Dosage and Administration 100 words ▾

Directions • Thoroughly cleanse the skin before applying the product. • Using the pad, apply a thin layer to cover the entire affected area one to two times daily. • Wash hands thoroughly after application. • As excessive skin dryness may occur, begin with one application daily. Gradually, increase to two applications daily if needed or as directed by a physician. • If significant dryness or peeling develops, reduce use to once daily or every other day. • Do not leave the pad on prolonged contact with the skin. • Avoid contact with the eyes, lips, and other mucous membranes.

⚠️ Warnings 104 words ▾

Warnings For external use only. Allergy alert: do not use this product if you have a known allergy to Salicylic Acid. Do not use: • on damaged and broken skin. • on large areas of the body.

When using this product • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, use only one topical acne medication at a time. Stop use and ask a doctor if irritation becomes severe.

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

📦 Storage and Handling 14 words ▾

Other information • Keep tightly closed • store in a cool & dry place.

🧪 Active Ingredient 5 words ▾

Active Ingredients Salicylic Acid 2%

🧪 Inactive Ingredients 40 words ▾

Inactive Ingredients Water, Propanediol, Ammonium Lauryl Sulfate, Betaine, Urea, Panthenol, Sodium PCA, Allantoin, Didecyldimonium Chloride, Polyquaternium-80, Sodium Hydroxide, Caprylyl Glycol, Methylpropanediol, Sodium Benzoate, Citrus Paradisi (Grapefruit) Peel Oil, Copaifera Officinalis (Balsam Copaiba) Resin, Leptospermum Scoparium Oil, Tocopherol, Citric Acid, Limonene.

🎯 Purpose 3 words ▾

Purpose Acne Treatment

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Questions or Comments 6 words ▾

Questions {or Comments}? 781. 281. 0954

📄 Package Label / Principal Display Panel 2 words ▾

Packaging CATHERINEHINDSPURIFYINGPADS

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 ESSENCE BY CATHERINE HINDS PURIFYING PADS with 2% Salicylic Acid (this brand).

Top reported reactions

Vomiting216
Pruritus205
Weight Decreased188
Condition Aggravated184
Urticaria184
Weight Increased183
Hypertension181

Reporter sex

1,853 reports

Serious outcomes

Death611
Disabling124
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 252 0
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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 Anna Lotan Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Anna Lotan Ltd. 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.