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Miconazole Nitrate 1.42 g/71g Powder, 71 g — NDC 70000-0323-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Miconazole Nitrate 1.42 g/71g Powder, 71 g — NDC 70000-0323-1 (Billing 70000-0323-01)

by LEADER/ Cardinal Health 110, Inc. · 71 g in 1 BOTTLE, WITH APPLICATOR

This is a package of 71 g of Miconazole Nitrate 1.42 g/71g Powder from LEADER/ Cardinal Health 110, Inc., no longer marketed (first marketed Oct 2017), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $0.0579 per g (NADAC). It is this product's only package size.

NDC 70000-0323-01
🏷️ FDA NDC (as labeled) 70000-0323-1 billing pads the package segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 70000-0323-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
70000 labeler · 0323 product · 1 package
Package marketed since
Oct 20, 2017
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Billing quantity
71 g per package
Barcode (UPC-A, from the NDC)
3 7000003231 9
Medicaid fills, this package
1,811 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0323-1
Product NDC 70000-0323
11-digit billing NDC 70000032301
NCPDP billing unit GM — per gram (weight)
RxCUI 998461
UNII VW4H1CYW1K
Application # M005
SPL Set ID e754d590-0a92-4605-89a3-e698b8906672
Established class (EPC) Azole Antifungal
Chemical class Azoles
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2017-10-20
Marketing end 2026-09-30
Route TOPICAL
Dosage form POWDER
Substance MICONAZOLE NITRATE

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

GPI-14 90154050102910
GPI class Antifungal
GCN Seq No 007367
GCN 30410
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% POWDER
FDB brand name Antifungal Powder
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007367
  • GCN: 30410
  • GPI-14 (Medi-Span): 90154050102910
  • HICL (First Databank): 003031
  • AHFS class code: 84:04.08.08
  • RxCUI (RxNorm): 998461
Why two NDCs? The FDA registers this code as 70000-0323-1 — a 5-4-1 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 package segment → 70000-0323-01. 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

Label name ANTIFUNGAL 2% POWDER Ingredient Miconazole Nitrate
📖 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 $0.058 $4.11 / 71 g
Medicaid paysCMS SDUD · 12 mo $0.1622 $11.52 / 71 g
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.058 $0.044
▲ Up 30% over the last 24 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
70000-0323-01 You're viewing this Main listing 71 g in 1 BOTTLE, WITH APPLICATOR 2017-10-20 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Miconazorb AF 20 mg/g 46122-0789-29 AmerisourceBergen 71 g $0.058 — Availability likely —
Miconazole Nitrate 1.42 g/71gthis 70000-0323-01 LEADER/ 71 g $0.058 — Discontinued —
Antifungal Powder 20 mg/g 70000-0679-01 LEADER/ 71 g $0.058 — Availability likely —
Desenex 20 mg/g 00316-0225-15 Crown 43 g — — Discontinued —
Zeasorb Athletes Foot 20 mg/g 00316-8000-01 Crown 71 g — — FDA listed —
Zeasorb Jock Itch 20 mg/g 00316-8001-02 Crown 71 g — — FDA listed —
Foot Powder 20 mg/g 00363-7999-01 Walgreens 71 g — — FDA listed —
Jock Itch Powder 20 mg/g 00363-9223-01 Walgreens 71 g — — FDA listed —
Miconazole Nitrate Antifungal Powder 2 g/100g 10135-0720-85 Marlex 85 g — — FDA listed —
Lotrimin AF Jock Itch 20 mg/g 11523-0150-01 Bayer 177 g — — FDA listed —
Lotrimin Antifungal 20 mg/g 11523-0919-01 Bayer 90 g — — FDA listed —
Micro-Guard (AF) 20 mg/g 11701-0038-16 Coloplast 85 g — — FDA listed —
Anti-Fungal Powder 20 mg/g 30142-0947-71 The 71 g — — FDA listed —
Miconazole Nitrate 1.42 g/71g 36800-0385-25 Topco 71 g — — Discontinued —
Anti-Fungal Powder 20 mg/g 36800-0613-01 TopCo 71 g — — FDA listed —
Miconazole Nitrate 2 g/100g 42291-0938-85 AvKARE 85 g — — FDA listed —
Anti-Fungal Powder 20 mg/g 51316-0980-01 CVS 71 g — — FDA listed —
Remedy Antifungal 2 g/100g 53329-0169-79 Medline 85 g — — FDA listed —
Miconazole Nitrate 20 mg/g 53943-0976-01 Discount 71 g — — FDA listed —
ProCure Antifungal 2 g/100g 55681-0043-03 Twin 85 g — — FDA listed —
Anti- Fungal Miconazole Nitrate 1.42 g/71g 56104-0253-01 Premier 71 g — — FDA listed —
Anti-fungal Powder Miconazole Nitrate 20 mg/g 56104-0500-00 Premier 71 g — — FDA listed —
Medicated Athletes Foot Powder 20 mg/g 56104-0906-01 Premier 99 g — — FDA listed —
Mycozyl AP 2 g/85g 59088-0442-07 PureTek 85 g — — FDA listed —
Micotrin AP 2 g/85g 59088-0478-07 PureTek 85 g — — FDA listed —
1236-CS Antifungal Powder (Talc Free) 20 mg/g 67777-0313-04 Dynarex 24 bottles — — FDA listed —
THERA Antifungal Body 20 mg/g 68599-0207-03 McKesson 85 g — — FDA listed —
GeriGentle Miconazole nitrate 2 g/100g 69771-0165-03 GERI-GENTLE 85 g — — FDA listed —
Miconazole Nitrate 1.42 g/71g 69842-0490-25 CVS 71 g — — FDA listed —
Miconazole Nitrate 1.42 g/71g 72446-0007-71 Hudson 71 g — — FDA listed —
Miconazole Nitrate 20 mg/g 72446-0014-01 Hudson 71 g — — FDA listed —
DCH Labs Antifungal Jock 2 g/100g 72839-0096-02 Derma 71 g — — FDA listed —
Warrior Antifungal Foot 2 g/100g 72839-0961-02 Derma 71 g — — FDA listed —
Anti-fungal Powder Miconazole Nitrate 20 mg/g 79481-0621-01 Meijer 71 g — — FDA listed —
Antifungal 20 mg/g 80513-0771-03 Advanced 85 g — — FDA listed —
Evercare Antifungal Treatment Super Absorbent Powder 20 mg/g 83099-0000-00 PANEFFORT, 85 g — — FDA listed —
Dermachange Jock 2 g/100g 83520-0961-02 Private 71 g — — FDA listed —
Happy Nuts Jock Itch Powder 2 g/100g 87151-0111-01 Suit 71 g — — FDA listed —
Antifungal Powder 2 g/100g 87236-0012-03 Aldermed 85 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

🏛️
2017
On the market since
Oct 2017
📍
2026
Currently FDA-listed
9 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

LabelerLEADER/ Cardinal Health 110, Inc.
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code70000
First marketedOct 2017
Product typeHuman Otc Drug
Portfolio38 products on file

More NDCs from LEADER/ Cardinal Health 110, Inc. labeler code 70000

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 12 words ▾

Uses for the cure of most athlete's foot, jock itch and ringworm

⏱️ Dosage and Administration 95 words ▾

Directions clean the affected area and dry thoroughly apply a thin layer of 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 spaces between the toes; wear well-fitting, 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 conditions persist longer, consult a doctor this product is not effective on the scalp or nails

⚠️ Warnings 89 words ▾

Warnings For external use only. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

🧪 Active Ingredient 5 words ▾

Active ingredient Miconazole nitrate 2%

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Do Not Use 14 words ▾

Do not use on children 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 27 words ▾

Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

📄 Keep Out of Reach of Children 34 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor.

📄 Other Information 14 words ▾

Other information store between 59º - 86ºF lightly shake bottle to loosen settled powder

📄 Questions or Comments 3 words ▾

Questions? call 1-866-964-0939

📄 Package Label / Principal Display Panel 40 words ▾

Principal Display Panel LEADER Moisture Absorbing Antifungal Powder Miconzole Nitrate 2% | Antfungal Cures Most Athlete's Foot, Jock Itch, and Ringworm Relieves Chafing, Itching, Burning, and Scaling Absorbs Moisture Talc - Free

2.5OZ (71 g) Leader_Antifungal Miconazorb Powder Talc-Free_50-081LD_51-081LD.jpg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.8K
Units reimbursed last 4 qtrs
128.7K
Gross reimbursed last 4 qtrs
$20.9K
Avg / prescription
$11.52
Avg / unit
$0.1622
Latest quarter Q4 2025
255Rx
Medicaid pays / g
$0.1622
gross reimbursed
vs
NADAC / g
$0.0579
acquisition cost
=
Spread
+$0.1043
+180% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
41% FFS 59% MCO
Fee-for-service · 739 Rx Managed care · 1,072 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 11,029 units · 192 per 100k residents MN Wisconsin: 7,538 units · 128 per 100k residents WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 923 units · 21.8 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 24,242 units · 353 per 100k residents IN Ohio: 21,340 units · 181 per 100k residents OH Pennsylvania: 12,277 units · 94.7 per 100k residents PA New Jersey: 4,984 units · 53.6 per 100k residents NJ Massachusetts: 3,360 units · 48.0 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 21,069 units · 1,065 per 100k residents NE Missouri: 5,822 units · 94.0 per 100k residents MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 867 units · 9.9 per 100k residents VA Maryland: no data reported MD Connecticut: 5,609 units · 155 per 100k residents CT Rhode Island: 2,201 units · 201 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 5,296 units · 180 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 2,144 units · 7.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
7.01,065
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nebraska 1,065 /100k
2 Indiana 353 /100k
3 Rhode Island 201 /100k
4 Minnesota 192 /100k
5 Ohio 181 /100k
6 Kansas 180 /100k
7 Connecticut 155 /100k
8 Wisconsin 128 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) — 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) ✓ Available
“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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
LEADER/ Cardinal Health 110, 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.
← 70000-0322-01 · LEADER/ 70000-0324-01 · Cardinal →
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.