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Vagisten-V 7 Day Miconazole Nitrate 2 g/100g Cream — NDC 69729-0612-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Vagisten-V 7 Day Miconazole Nitrate 2 g/100g Cream — NDC 69729-612-05 (Billing 69729-0612-05)

by OPMX LLC · 1 TUBE in 1 BOX / 14 g in 1 TUBE

This is a package of Vagisten-V 7 Day Miconazole Nitrate 2 g/100g Cream from OPMX LLC, marketed since Sep 2018 and currently FDA-listed. It is this product's only package size.

NDC 69729-0612-05
🏷️ FDA NDC (as labeled) 69729-612-05 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69729-612-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69729 labeler · 612 product · 05 package
Package marketed since
Sep 5, 2018
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0856828008212
FDA record last changed
Jul 24, 2026
⚠️
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) 69729-612-05
Product NDC 69729-612
11-digit billing NDC 69729061205
RxCUI 998540
UNII VW4H1CYW1K
UPC 0856828008212
Application # M005
SPL Set ID a5bfa501-5ae1-4434-bc31-995d0665b99e
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 2018-09-05
Route VAGINAL
Dosage form CREAM
Substance MICONAZOLE NITRATE
Quick answers
  • RxCUI (RxNorm): 998540
Why two NDCs? The FDA registers this code as 69729-612-05 — 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 → 69729-0612-05. 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

Vaginal miconazole is used to treat vaginal yeast infections in adults and children 12 years of age and older. Miconazole is in a class of antifungal medications called imidazoles. It works by stopping the growth of fungi that cause infection.

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
69729-0612-05 You're viewing this Main listing 1 TUBE in 1 BOX / 14 g in 1 TUBE 2018-09-05 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Miconazole 7 2 g/100g 00113-0214-29 L 1 tube $0.119 — Availability likely —
good sense miconazole 7 2 g/100g 00113-0825-29 L. 1 tube $0.119 — Availability likely —
Miconazole 7 20 mg/g 00904-7734-45 Major 1 tube $0.119 — Availability likely —
Good Neighbor Pharmacy Miconazole 7 2 g/100g 24385-0590-29 Amerisource 1 tube $0.119 — Availability likely —
Miconazole Nitrate 20 mg/g 51672-2035-06 Sun 1 tube $0.119 — Availability likely —
Miconazole 7 20 mg/g 61269-0730-41 H2-Pharma, 1 tube $0.119 — Availability likely —
Miconazole 7 20 mg/g 70000-0009-01 Cardinal 1 tube $0.119 — Availability likely —
foster and thrive miconazole 2 g/100g 70677-1222-01 Strategic 1 tube $0.119 — Availability likely —
foster and thrive miconazole 7 2 g/100g 70677-1225-01 Strategic 1 tube $0.119 — Availability likely —
Miconazole 7 20 mg/g 83324-0160-15 QUALITY 1 tube $0.119 — Availability likely —
Miconazole 7 20 mg/g 63868-0198-45 QUALITY 1 tube $0.130 — FDA listed —
Miconazole 7 20 mg/g 00363-0730-41 Walgreens 1 tube — — FDA listed —
vagisil brand vagistat 2 g/100g 11509-0825-01 Combe 1 tube — — FDA listed —
Miconazole 7 20 mg/g 11673-0049-06 TARGET 1 tube — — FDA listed —
up and up miconazole 7 2 g/100g 11673-0825-29 Target 1 tube — — FDA listed —
Miconazole 7 2 g/100g 21130-0696-29 Safeway 1 tube — — FDA listed —
signature care miconazole 7 2 g/100g 21130-0825-29 Safeway 1 tube — — FDA listed —
Miconazole 7 2 g/100g 30142-0825-29 Kroger 1 tube — — FDA listed —
Topcare Miconazole 7 2 g/100g 36800-0825-29 Topco 1 tube — — FDA listed —
miconazole 7 2 g/100g 37808-0825-29 H 1 tube — — FDA listed —
Equaline Miconazole 7 2 g/100g 41163-0825-29 United 1 tube — — FDA listed —
Miconazole 7 2 g/100g 41250-0825-29 Meijer 1 tube — — FDA listed —
Careone miconazole 7 2 g/100g 41520-0825-29 American 1 tube — — FDA listed —
miconazole 7 2 g/100g 42507-0769-29 HyVee 1 tube — — FDA listed —
Miconazole 7 100 mg/g 49035-0347-07 EQUATE 7 tubes — — FDA listed —
Miconazole Nitrate 20 mg/g 50090-4356-00 A-S 1 tube — — FDA listed —
Miconazole 7 20 mg/g 55319-0573-15 Family 1 tube — — FDA listed —
DG Health Miconazole 2 g/100g 55910-0698-29 Dolgencorp 1 tube — — FDA listed —
Miconazole 7 20 mg/g 59726-0988-01 P 1 tube — — FDA listed —
Monistat 7 with Reusable Applicator 20 mg/g 63736-0025-15 Insight 1 tube — — FDA listed —
Monistat 7 7-Day Disposable Applicators 20 mg/g 63736-0026-15 Insight 7 tubes — — FDA listed —
Miconazole 7 20 mg/g 68071-3544-07 NuCare 1 tube — — FDA listed —
good sense miconazole 7 2 g/100g 68788-4117-04 Preferred 1 tube — — FDA listed —
Miconazole 7 20 mg/g 68788-7917-04 Preferred 1 tube — — FDA listed —
Miconazole 7 20 mg/g 68788-8661-04 Preferred 1 tube — — FDA listed —
Vagisten-V 7 Day 2 g/100gthis 69729-0612-05 OPMX 1 tube — — FDA listed —
Basic Care Miconazole 7 2 g/100g 72288-0825-29 Amazon.com 1 tube — — FDA listed —
Dr. Rainer s Vaginal Cream 2 g/100mL 73736-0115-05 Plexoris 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

🏛️
2018
On the market since
Sep 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 Miconazole 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 8SKN0B0MIM
    Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
  • UNII REK4960K2U
    Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
  • UNII 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • 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 0240V77G50
    A synthetic compound made by combining polyethylene glycol with oleic acid (a natural fatty acid). It acts as an emulsifier and solubilizer to help mix water and oil-based ingredients in the medicine.
  • UNII 3EW5AXE5X5
    A synthetic surfactant derived from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and improves how the medicine dissolves and is absorbed in the body.
  • 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 statesBENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER

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

LabelerOPMX LLC
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedSep 2018
Product typeHuman Otc Drug
Portfolio87 products on file

More NDCs from OPMX LLC labeler code 69729

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 15 words ▾

USES TREATS VAGINAL YEAST INFECTIONS RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION

⏱️ Dosage and Administration 103 words ▾

DIRECTIONS BEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATION ADULTS AND CHILDREN 12 YEARS OF AGE OR OVER: APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE. EXTERNAL CREAM: USE THE SAME TUBE OF CREAM IF YOU HAVE ITCHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA.

SQUEEZE A SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ITCHY, IRRITATED SKIN OUTSIDE THE VAGINA (VULVA). USE 2 TIMES DAILY FOR UP TO 7 DAYS AS NEEDED.

CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

⚠️ Warnings 219 words ▾

WARNINGS FOR VAGINAL USE ONLY. DO NOT USE IF YOU HAVE NEVER HAD A VAGINAL YEAST INFECTION DIAGNOSED BY A DOCTOR. ASK A DOCTOR BEFORE USE IF YOU HAVE VAGINAL ITCHING AND DISCOMFORT FOR FIRST TIME LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NASEA, VOMITING, OR FOUL-SMELLING VAGINAL DISCHARGE.

YOU MAY HAVE A MORE SERIOUS CONDITION. VAGINAL YEAST INFECTIONS OFTEN (SUCH AS ONCE A MONTH OR 3 IN 6 MONTHS). YOU COULD BE PREGNANT OR HAVE SERIOUS UNDERLYING MEDICAL CAUSE FOR YOUR SYMPTOMS, INCLUDING DIABETES OR A WEAKENED IMMUNE SYSTEM.

BEEN EXPOSED TO THE HUMAN IMMUNODEFICIENCY VIRUS (HIV) THAT CAUSES AIDS. ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU HAVE TAKEN A PRESCRIPTION BLOOD THINNING MEDICINE, SUCH AS WARFARIN, BECAUSE BLEEDING OR BRUISING MAY OCCUR. WHEN USING THIS PRODUCT DO NOT USE TAMPONS, DOUCHES, SPERMACIDES OR OTHER VAGINAL PRODUCTS.

CONDOMS AND DIAPHRAGMS MAY BE DAMAGED OR FAIL TO PREVENT PREGNANCY OR SEXUALLY TRANSMITTED DISEASES (STDS). DO NOT HAVE VAGINAL INTERCOURSE MILD INCREASE IN VAGINAL BURNING, ITCHING OR IRRITATION MAY OCCUR. STOP USE AND ASK A DOCTOR IF SYMPTOMS DO NOT GET BETTER IN 3 DAYS SYMPTOMS LAST MORE THAN 7 DAYS YOU GET A RASH OR HIVESS, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA, VOMITING OR FOUL-SMELLING DISCHARGE IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

🧪 Active Ingredient 10 words ▾

ACTIVE INGREDIENTS MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

🧪 Inactive Ingredients 18 words ▾

INACTIVE INGREDIENTS BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER

🎯 Purpose 3 words ▾

PURPOSE VAGINAL ANTIFUNGAL

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Other Information 26 words ▾

OTHER INFORMATION DO NOT USE IF SEAL TUBE OPENING HAS BEEN PUNCTURED DO NOT PURCHASE IF CARTON OPEN STORE AT 20° - 25°C (68°F - 77°F)

📄 Package Label / Principal Display Panel 6 words ▾

0-UC_VAGISTEN-V CREMA 2pct_front 0-UC_VAGISTEN-V CREMA 2pct_back

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.

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 VAGISTEN-V 7 DAY (this brand).

Top reported reactions

Vulvovaginal Burning Sensation242
Vulvovaginal Pain79
Vulvovaginal Pruritus73
Condition Aggravated72
Drug Interaction58
Vulvovaginal Discomfort47
Vaginal Haemorrhage42

Age at onset

Neonate1
Infant3
Child3
Adolescent2
Adult79
Elderly62

Reporter sex

1,338 reports
Male · 24%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization303
Death85
Life-threatening53
Disabling21
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 139 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 OPMX LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
OPMX LLC 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.
← 69729-0610-05 · OPMX 69729-0615-05 · OPMX →
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.