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Recuren Plus Antifungal Cream Miconazole Nitrate 2% 20 mg/g Cream, 100 g — NDC 87014-0001-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Recuren Plus Antifungal Cream Miconazole Nitrate 2% 20 mg/g Cream, 100 g — NDC 87014-001-01 (Billing 87014-0001-01)

by REGENEREN PLUS LTD · 100 g in 1 CARTON

This is a package of 100 g of Recuren Plus Antifungal Cream Miconazole Nitrate 2% 20 mg/g Cream from REGENEREN PLUS LTD, marketed since Feb 2026 and currently FDA-listed. It is this product's only package size.

NDC 87014-0001-01
🏷️ FDA NDC (as labeled) 87014-001-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87014-001-01
Product NDC 87014-001
11-digit billing NDC 87014000101
RxCUI 998483
UNII VW4H1CYW1K
Application # M002
SPL Set ID 3c28a93a-dd42-65b8-e063-6294a90ae6ab
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 2026-02-13
Route TOPICAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
Quick answers
  • RxCUI (RxNorm): 998483
Why two NDCs? The FDA registers this code as 87014-001-01 — 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 → 87014-0001-01. 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 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

📖 What it is MedlinePlus · NLM

Topical miconazole is used to treat tinea corporis(ringworm; fungal skin infection that causes a red scaly rash on different parts of the body), tinea cruris (jock itch; fungal infection of the skin in the groin or buttocks), and tinea pedis (athlete's foot; fungal infection of the skin on the feet and between the toes). Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection. Not all products should be used to treat all of these conditions. Please read the label for each product to select the one to treat your conditi...

Read the full MedlinePlus article ↗
📗 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 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
87014-0001-01 You're viewing this Main listing 100 g in 1 CARTON 2026-02-13 — 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 —
Antifungal Cream 2 g/100g 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 —
Miconazole Nitrate Cream USP, 2% 2 g/100g 70000-0340-01 Cardinal 28.4 g $0.082 — Availability likely —
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g 00536-1375-75 Rugby 1 tube $0.121 — Availability likely —
Miconazole Nitrate 20 mg/g 70677-1000-01 STRATEGIC 1 tube $0.121 — Availability likely —
SUNMARK MICONAZOLE NITRATE antifungal 20 mg/g 49348-0689-72 Strategic 1 tube $0.122 — Availability likely —
Miconazole Nitrate 20 mg/g 51672-2001-01 Sun 1 tube $0.201 — Availability likely —
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/gthis 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 —
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
Feb 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.

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

  • UNII JQ7YW886UQ
    A natural oil extracted from aloe vera plant leaves. It's used in medicines as a skin-soothing ingredient and lubricant to improve texture and glide in topical formulations.
  • 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 M89NIB437X
    Borneol is a waxy, plant-derived alcohol obtained from camphor trees or made synthetically. It's used in medicines as a flavoring agent and penetration enhancer to improve how active ingredients are absorbed.
  • UNII 578389D6D0
    Clove oil is an essential oil derived from clove plant buds. It's used in medicines as a flavoring agent and for its mild preservative properties to help maintain product stability.
  • UNII 2R04ONI662
    Eucalyptus oil is a fragrant liquid extracted from eucalyptus tree leaves. It's used in medicines as a flavor, scent, or soothing agent in topical products and cough preparations.
  • 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 ZBP1YXW0H8
    A fragrant oil extracted from lavender plants, used as a flavoring and scent agent in medicines to improve taste and aroma.
  • UNII 61ZBX54883
    Licorice is a natural extract from the licorice plant root. It's used in medicines as a flavoring agent to mask bitter tastes and improve how the medicine tastes.
  • UNII 3VNC7T6Z02
    A plant extract from chamomile flowers used as a flavoring and fragrance agent in medicines. It adds taste and aroma to improve how the medicine smells and tastes.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII VIF565UC2G
    Tea tree oil is an essential oil extracted from the leaves of the Australian tea tree plant. In medicines, it typically serves as a flavoring agent, fragrance, or antimicrobial component in topical formulations.
  • UNII R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.

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

The official label also statesAqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.

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

LabelerREGENEREN PLUS LTD
FDA applicationM002 (OTC MONOGRAPH DRUG)
Labeler code87014
First marketedFeb 2026
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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 55 words ▾

Clean and dry affected area thoroughly Apply a thin layer of cream over affected area twice daily (morning and night), or as directed by a doctor Supervise children in use of this product For athlete’s foot: pay special attention to spaces between toes Wear well-fitting, ventilated shoes Change shoes and socks at least once daily

⏱️ Dosage and Administration 28 words ▾

athlete’s foot: 4 weeks ringworm: 4 weeks jock itch: 2 weeks if condition persists longer, consult a doctor. This product is not effective on the scalp or nails

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 3 words ▾

Miconazole Nitrate 2%

🧪 Inactive Ingredients 46 words ▾

Aqua (Water), Melaleuca Alternifolia (Tea Tree) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Eugenia Caryophyllus (Clove) Leaf Oil/Bud Oil, Aloe Barbadensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Chamomilla Recutita (Matricaria) Flower Extract, Eucalyptus Globulus Leaf Oil, Tocopherol, Borneol, Menthol, Stearic Acid, Petrolatum, Paraffinum Liquidum, Glycerin, Triethanolamine.

🎯 Purpose 1 words ▾

Antifungal

📄 Do Not Use 22 words ▾

on children under 3 years of age unless directed by a doctor on sensitive or broken skin unless directed by a doctor

📄 Ask a Doctor Before Use If 20 words ▾

There is no improvement within 4 weeks (athlete’s foot or ringworm) There is no improvement within 2 weeks (jock itch)

📄 When Using This Product 11 words ▾

Avoid contact with eyes Discontinue use if irritation occurs or worsens

📄 Stop Use and Ask a Doctor If 2 words ▾

Irritation occurs

📄 Keep Out of Reach of Children 6 words ▾

Keep Out of Reach of Children

📄 Questions or Comments 5 words ▾

Please contact the email: [email protected]

📖 Instructions for Use 24 words ▾

Treats most athlete’s foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). Relieves itching, burning, cracking, and scaling associated with these conditions.

📄 Package Label / Principal Display Panel 1 words ▾

3

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

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 Recuren Plus Antifungal Cream (this brand).

Top reported reactions

Bacteraemia1
Cellulitis1
Dehydration1
Diabetic Ketoacidosis1
Disease Progression1
Dysgeusia1
Environmental Exposure1

Reporter sex

3 reports
Male · 67%
Female · 33%

Serious outcomes

Hospitalization1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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 ✓ 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 REGENEREN PLUS LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
REGENEREN PLUS 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.
← 87013-0004-01 · GENUINE 87014-0002-01 · REGENEREN →
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.