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Desenex MICONAZOLE NITRATE 20 mg/g Powder, 85 g — NDC 00316-0225-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Desenex MICONAZOLE NITRATE 20 mg/g Powder, 85 g — NDC 0316-0225-30 (Billing 00316-0225-30)

by Crown Laboratories · 85 g in 1 CONTAINER

This is a package of 85 g of Desenex MICONAZOLE NITRATE 20 mg/g Powder from Crown Laboratories, no longer marketed (first marketed Oct 2023), no longer in the FDA NDC Directory.

NDC 00316-0225-30
🏷️ FDA NDC (as labeled) 0316-0225-30 billing pads the labeler segment with a zero
This package
Contains85 g Pack sizes4 compare ↓
Product page 00316-0225-01 Also comes in: 43 g 0316-0225-15 43 g 0316-0225-01 85 g 0316-0225-02
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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 0316-0225-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0316 labeler · 0225 product · 30 package
Listing certified through
Dec 31, 2027
Billing quantity
85 g per package
Barcode (UPC)
0303160225154
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 ↗
⚠️
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 Jul 2025. 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) 0316-0225-30
Product NDC 0316-0225
11-digit billing NDC 00316022530
NCPDP billing unit GM — per gram (weight)
RxCUI 998461, 998465
UNII VW4H1CYW1K
UPC 0303160225154
Application # M005
SPL Set ID 09964187-12f1-bbe6-e063-6394a90acba0
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 Jul 2025)
Marketing start 2023-10-19
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 Desenex
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 DESENEX 2% POWDER
FDB brand name Desenex
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 0316-0225-30 — a 4-4-2 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 labeler segment → 00316-0225-30. 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 DESENEX 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 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.
Try another pack size: 43 g 43 g 85 g
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
00316-0225-15 0316-0225-15 43 g in 1 CONTAINER 2018-12-01 — Discontinued by firm
00316-0225-30 You're viewing this 85 g in 1 CONTAINER 2018-12-01 — Discontinued by firm
00316-0225-01 0316-0225-01 Main listing 43 g in 1 BOTTLE, PLASTIC 2023-10-19 — Active
00316-0225-02 0316-0225-02 85 g in 1 BOTTLE, PLASTIC 2023-10-19 — Active

Pack size FAQ

What quantity is in this package?
This package contains 85 g — 85 g in 1 container.
How does this package differ from NDC 00316-0225-15?
Both are Desenex MICONAZOLE NITRATE 20 mg/g Powder — the drug itself is identical. This page's package is the 85 g one, while NDC 00316-0225-15 is the 43 g package.
What NDC number is used to bill for this package of Desenex MICONAZOLE NITRATE 20 mg/g Powder?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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/71g 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/gthis 00316-0225-30 Crown 85 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 —
Jock Itch Powder 20 mg/g 56104-0122-01 Premier 127 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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

🧪 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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • 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 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 24SC3U704I
    A powdery carbohydrate extracted from tapioca plant roots. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your digestive system.
  • UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.
  • 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 44FQ49X6UN
    A polysaccharide (complex carbohydrate) derived from yeast cell walls. In medicines, it acts as a binder to hold tablet ingredients together and may help with tablet structure and stability.

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

The official label also states1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

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

LabelerCrown Laboratories
FDA applicationM005 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio43 products on file

More NDCs from Crown Laboratories labeler code 00316

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 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses Cures most athlete’s foot (tinea pedis) Relieves itching, burning, cracking, and discomfort

⏱️ Dosage and Administration 81 words ▾

Directions Wash 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.

Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor.

This product is not effective on the scalp or nails.

⚠️ Warnings 61 words ▾

Warnings For external use only. Avoid contact with eyes. Do not use on children under 2 years of age unless directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

📦 Storage and Handling 21 words ▾

Other information store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].

🧪 Active Ingredient 5 words ▾

Active ingredient Miconazole nitrate 2%

🧪 Inactive Ingredients 26 words ▾

Inactive ingredients 1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

🎯 Purpose 2 words ▾

Purpose Antifungal

📄 Do Not Use 33 words ▾

Do not use on children under 2 years of age unless directed by a doctor. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

📄 Questions or Comments 3 words ▾

Questions? call 1-833-279-6522

📄 Package Label / Principal Display Panel 70 words ▾

Principal Display Desenex® Antifungal Foot Powder with 2% Miconazole Nitrate PRESCRIPTION STRENGTH Cures Most Athlete's Foot Triple Action Powder Relieves Itching, Burning, and Scaling Attacks and Absorbs Moisture All Day Odor Control NET WT. 1.5 oz [43g] PRODUCT PACKAGED BY WEIGHT NOT VOLUME ©2023 Crown Laboratories, Inc. Distributed by: Crown Laboratories, Inc .

Johnson City, TN 37604 DESENEX is a registered trademark of Crown Laboratories, Inc. P12319.01 Desenex 1.5oz label

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 Desenex (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

1,364 reports
Male · 24%
Female · 76%
Unknown · 0%

Serious outcomes

Hospitalization312
Death90
Life-threatening53
Disabling23
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 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) ✓ 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.
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.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 43 g (00316-0225-15), 43 g (00316-0225-01), 85 g (00316-0225-02). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Crown Laboratories 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.
← 00316-0223-15 · Crown 00316-0226-08 · Crown →
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.