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Antifungal Cream Miconazole Nitrate 2 g/100g Cream, 1 tube — NDC 21922-095-06 (Billing 21922-0095-06)

by Encube Ethicals, Inc. · 1 TUBE in 1 CARTON / 42.5 g in 1 TUBE

This is a package of 1 tube of Antifungal Cream Miconazole Nitrate 2 g/100g Cream from Encube Ethicals, Inc., marketed since Mar 2025 and currently FDA-listed; retail pharmacies pay about $0.0795 per g (NADAC). It is this product's only package size.

NDC 21922-0095-06
🏷️ FDA NDC (as labeled) 21922-095-06 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

⚠️
Other active recalls for Miconazole Nitrate (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 · Jan 10, 2024 — Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0315-2024
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) 21922-095-06
Product NDC 21922-095
11-digit billing NDC 21922009506
NCPDP billing unit GM — per gram (weight)
RxCUI 998483
UNII VW4H1CYW1K
UPC 0321922095067
Application # M005
SPL Set ID 8be4bbfa-424c-4ccf-b8bc-65b16c126053
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-03-06
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90154050103705
GCN Seq No 007366
GCN 30400
HICL code 003031
Ingredient (HICL) Miconazole Nitrate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5F
Therapeutic class — specific (HIC3) Topical Antifungals
AHFS code 84:04.08.08
AHFS class Azoles (Skin And Mucous Membrane)
FDB label name ANTIFUNGAL 2% TOPICAL CREAM
FDB brand name Antifungal Cream
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007366
  • GCN: 30400
  • GPI-14 (Medi-Span): 90154050103705
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 998483
Why two NDCs? The FDA registers this code as 21922-095-06 — 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 → 21922-0095-06. 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 Azole Antifungal class.

Pharmacologic class Azole Antifungal
Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Imidazole derivatives, Imidazole and triazole derivatives
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

Label name ANTIFUNGAL 2% TOPICAL CREAM Ingredient Miconazole Nitrate
📗 Our plain-language guide HelloPharmacist
  • It treats fungal and yeast infections. Depending on the product, that means vaginal yeast infections, athlete's foot, jock itch, ringworm, or thrush in the mouth and throat (Oravig...
  • Apply it to your upper gum in the morning after brushing, with dry hands. Hold it in place for 30 seconds. Don't crush, chew or swallow it. Use it once a day for 14 days.
  • Most are mild, like diarrhea, nausea, headache, upper belly pain or a change in taste. Vaginal products may cause mild burning or itching at first. Stop and get help for hives, tro...
  • Tell me if you take warfarin. Miconazole can boost its blood-thinning effect, so watch for bleeding or bruising. With Oravig, oral diabetes medicines, phenytoin and ergot alkaloids...
📖 Read our full Miconazole 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 $0.080 $3.38 / 42.5 g
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.
NADAC price history (per g) — tap or hover for the price & month
Aug 2026 Sep 2026 $0.080 $0.080
Flat over the last 2 months.
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
21922-0095-06 You're viewing this Main listing 1 TUBE in 1 CARTON / 42.5 g in 1 TUBE 2025-03-06 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 70000-0718-01 Cardinal 1 tube $0.078 — Availability likely save 2%
Antifungal Cream 2 g/100gthis 21922-0095-06 Encube 1 tube $0.079 — Availability likely —
Antifungal Cream 2 g/100g 68001-0481-45 BluePoint 1 tube $0.082 — Availability likely +3%
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.082 — Availability likely +3%
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.121 — Availability likely +52%
Miconazole Nitrate 20 mg/g 70677-1000-01 STRATEGIC 1 tube $0.121 — Availability likely +52%
SUNMARK MICONAZOLE NITRATE antifungal 20 mg/g 49348-0689-72 Strategic 1 tube $0.122 — Availability likely +53%
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.201 — Availability likely +153%
Selan Antifungal 2 g/100g 00159-2500-04 Trividia 117 g — — FDA listed —
Desenex Antifungal Foot Cream 20 mg/g 00316-0255-01 Crown 1 tube — — FDA listed —
Baza Antifungal 20 mg/g 11701-0045-14 Coloplast 142 g — — FDA listed —
MacerRx Web 2 g/100g 44577-0205-56 Clinical 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-1071-00 A-S 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-5607-00 A-S 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-5674-00 A-S 1 tube — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-7364-00 A-S 1 tube — — FDA listed —
CAREALL Miconazole Nitrate 20 mg/g 51824-0078-01 New 28 g — — FDA listed —
Anti-Fungal .02 g/g 52000-0021-37 Universal 1 tube — — FDA listed —
Medline 20 mg/mL 53329-0147-44 Medline 118 ml — — FDA listed —
Remedy Antifungal With Olivamine 2 g/100g 53329-0162-04 Medline 113 g — — Discontinued —
Medline 20 mg/100g 53329-0218-44 Medline 113 g — — FDA listed —
ProCure Antifungal Cream 2 g/100g 55681-0023-04 Twin 106 g — — FDA listed —
ProCure Antifungal 2 g/100g 55681-0047-04 Twin 106 g — — FDA listed —
Lasolex AC 2 g/100g 59088-0239-07 PureTek 85 g — — FDA listed —
Conazol 20 mg/g 59208-0001-30 Laboratorios 30 g — — FDA listed —
Private Label Antifungal Barrier Cream 20 g/1000g 60232-0009-02 Swiss-American 60 g — — FDA listed —
BOA VIDA Antifungal 2 g/100g 62654-0147-01 Central 113 g — — FDA listed —
Micatin 20 mg/g 65197-0103-05 WellSpring 14 g — — FDA listed —
Antifungal 2 g/100g 67777-0710-02 Dynarex 144 packets — — FDA listed —
Miconazole 20 mg/g 68016-0291-01 Chain 1 tube — — FDA listed —
MICONAZOLE Nitrate 2 g/100g 68071-3429-03 NuCare 1 tube — — FDA listed —
Antifungal Body 2 mg/100mL 68599-0206-04 McKesson 118 ml — — FDA listed —
Miconazole Nitrate 2 mg/100mg 68599-1471-04 McKesson 118 mg — — FDA listed —
Antifungal Cream 2 g/100g 68788-8645-02 Preferred 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8845-03 Preferred 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 68788-8895-03 Preferred 1 tube — — FDA listed —
PiYanPing Antifungal 2 g/100g 69070-0304-01 Zhejiang 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69396-0014-05 Trifecta 15 g — — FDA listed —
FifthPulse Miconazole Nitrate Cream 1oz 20 mg/g 69571-0016-01 Front 28.4 g — — FDA listed —
FifthPulse Miconazole Nitrate Cream 4oz 2 g/100g 69571-0017-01 Front 113.4 g — — FDA listed —
Secura Antifungal Greaseless 20 mg/g 69740-0328-00 Smith 57 g — — FDA listed —
Secura Antifungal Extra Thick 20 mg/g 69740-0329-00 Smith 92 g — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 69771-0041-25 GERI-GENTLE 113 g — — FDA listed —
MICONAZOLE Nitrate 2% 2 g/100g 71399-0071-01 Akron 1 tube — — FDA listed —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 77338-0041-25 ASTONEA 113 g — — FDA listed —
Athletes Foot 2 g/100mL 83004-0014-01 Rida 1 bottle — — FDA listed —
Fungazol Athlete Foot 2 g/100mL 83004-0025-01 Rida 1 bottle — — FDA listed —
Pharmlitalia Jock Itch Miconazole Nitrate 2 g/100mL 83004-0031-01 Rida 1 jar — — FDA listed —
ElixirTripleGuard Triple Antibiotic 2 g/100g 84546-0007-01 ELIXIR 113 g — — FDA listed —
Hermon Jock Itch Ringworm and athlete s foot cream 2 g/100g 84746-0008-01 Shandong 100 g — — Discontinued —
Nedtol Folliculitis Treatment Creams 2 g/100g 84867-0022-01 Jiashen 120 g — — FDA listed —
Beilloso Balanitis Relief 2 g/100mL 85248-0138-01 Jiangxi 30 ml — — FDA listed —
Inlifay ANTIFUNGAL 2 g/100g 85248-0139-01 Jiangxi 100 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0142-01 Jiangxi 100 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0212-01 Jiangxi 30 g — — FDA listed —
Charmpoo Antifungal Cream 2 g/100g 85248-0226-01 Jiangxi 2 tubes — — FDA listed —
BODYKOO ATHLETE FOOT Cream 2 g/100g 85248-0229-01 Jiangxi 30 g — — FDA listed —
Tagrid Jock Itch Miconazole Nitrate 2% 20 mg/g 85384-0003-01 TAGRID 100 g — — FDA listed —
Ringworm Treatment Cream 2 g/100g 85398-0024-01 Beautivity 100 g — — FDA listed —
Hermon Jock Itch Antifungal Treatment Cream 1.2 g/60g 85398-0032-01 Beautivity 60 g — — FDA listed —
RoyceDerm Tinea Antifungal Cream 20 mg/g 85424-0011-01 RoyceDerm 57 g — — FDA listed —
RoyceDerm Anti-Fungal Cream 2 g/100g 85424-0021-01 RoyceDerm 100 g — — FDA listed —
Aosorw Antifungal Cream 2 g/100g 85498-0011-01 SpineStatus 120 g — — FDA listed —
Kerova Miconazole Nitrate 2 g/100g 85959-0001-01 Guangzhou 100 g — — FDA listed —
Recuren Plus Antifungal Cream 20 mg/g 87014-0001-01 REGENEREN 100 g — — FDA listed —
Recuren Plus Jock Itch Cream 20 mg/g 87014-0004-01 REGENEREN 30 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0001-01 Trovina 100 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0002-01 Trovina 30 g — — FDA listed —
Kopa Haiku Antifungal Cream 20 mg/g 87041-0004-01 Trovina 60 g — — FDA listed —
Kopa Haiku Ringworm Treatment Cream 20 mg/g 87041-0008-01 Trovina 30 g — — FDA listed —
Miconazole Cream 2 g/100g 87236-0013-04 Aldermed 113 g — — FDA listed —
Doctor Jiao Antifungal Cream 2 g/100g 87537-0002-02 Jiangxi 1 tube — — FDA listed —
Lasolex AG 2 g/100g 59088-0207-07 Puretek 85 g — — FDA listed —
Femmesil Maximum Strength 2 g/100g 24909-0202-28 Aidance 1 bottle — — Discontinued —
White Tetterine 2 g/100g 12258-0242-01 S.S.S. 1 tube — — FDA listed —
Triple Antifungal 2 g/100g 16864-0040-02 Advantice 1 tube — — FDA listed —
Green Tetterine 2 g/100g 12258-0241-01 S.S.S. 1 can — — FDA listed —
Claravie 2 g/100g 61554-0305-11 Gentell 113 g — — FDA listed —
MOROVANJock Itch Antifungal 2 g/100g 87800-0006-01 HONG 100 g — — FDA listed —
Hermon Jock Itch Ringworm Athletes Foot Cream 2 g/100g 85398-0036-01 Beautivity 100 g — — 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

🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.

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

LabelerEncube Ethicals, Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code21922
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio77 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 27 words ▾

USE(S) ■ proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm ■ for effective relief of itching, scaling, cracking, burning, and discomfort

⏱️ Dosage and Administration 104 words ▾

DIRECTIONS ■ clean the affected area and dry thoroughly ■ apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor ■ supervise children in the use of this product ■ for athlete's foot: pay special attention to the spaces between the toes; wear well-filling, ventilated shoes, and change shoes and socks at least once daily ■ for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks ■ if condition lasts longer, contact a doctor ■ this product is not effective on the scalp or nails

⚠️ Warnings 5 words ▾

WARNINGS For external use only

📦 Storage and Handling 59 words ▾

OTHER INFORMATION ■ do not use if foil seal on tube opening is broken or missing ■ to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use ■ store at room temperature 15°C to 30°C (59°F to 86°F) ■ before using any medication, read all label directions. Keep carton, it contains important information.

🧪 Active Ingredient 6 words ▾

ACTIVE INGREDIENT(S) Miconazole nitrate, USP 2%

🧪 Inactive Ingredients 14 words ▾

INACTIVE INGREDIENTS benzoic acid, butylatyIated; hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7stearate, purified water

🎯 Purpose 2 words ▾

PURPOSE Antifungal

📄 Do Not Use 15 words ▾

DO NOT USE on children under 2 years of age unless directed by a doctor.

📄 When Using This Product 9 words ▾

WHEN USING THIS PRODUCT avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 29 words ▾

STOP USE AND ASK DOCTOR IF ■ irritation occurs ■ there is no improvement within 4 weeks (for athlete's foot and ringworm) or within 2 weeks (for jock itch)

📄 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 (1-800-222-1222) right away.

📄 Package Label / Principal Display Panel 17 words ▾

PRINCIPAL DISPLAY PANEL Antifungal Cream Miconazole Nitrate Cream, USP 2% NET WT.

1.5OZ (42.5 g) carton

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 Miconazole 3 (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 Miconazole 3. 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
$35.6K
Claims incl. refills
725
Beneficiaries
649
Spend / beneficiary
$54.91
Spend / claim
$49.15
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.

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) ✓ Available
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.
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 Encube Ethicals, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Encube Ethicals, 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.
← 21922-0094-04 · Encube 21922-0096-04 · Encube →
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.