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Shaant Spot Hero Drying Acne Treatment Sulfur 50 mg/mL Gel — NDC 83196-0690-12 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Shaant Spot Hero Drying Acne Treatment Sulfur 50 mg/mL Gel — NDC 83196-690-12 (Billing 83196-0690-12)

by Codex Labs Corporation · 1 TUBE in 1 CARTON / 15 mL in 1 TUBE

This is a package of Shaant Spot Hero Drying Acne Treatment Sulfur 50 mg/mL Gel from Codex Labs Corporation, marketed since May 2023 and currently FDA-listed. It is this product's only package size.

NDC 83196-0690-12
🏷️ FDA NDC (as labeled) 83196-690-12 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) 83196-690-12
Product NDC 83196-690
11-digit billing NDC 83196069012
RxCUI 283392
UNII 70FD1KFU70
Application # M006
SPL Set ID 24fa844b-e4ce-46de-a2d6-e9e863888a55
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-15
Route TOPICAL
Dosage form GEL
Substance SULFUR
Quick answers
  • RxCUI (RxNorm): 283392
Why two NDCs? The FDA registers this code as 83196-690-12 — 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 → 83196-0690-12. 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 Preparations containing sulfur class.

Drug family (ATC) Preparations containing sulfur
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 is this product?

Shaant Spot Hero Drying Acne Treatment is a topical gel containing sulfur, an OTC monograph drug sold without individual FDA approval but under established category rules. Sulfur is commonly included in acne products and functions as a keratolytic agent, meaning it helps break down and shed skin cells. This product is typically used for spot treatment of acne lesions on the skin.

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
83196-0690-12 You're viewing this Main listing 1 TUBE in 1 CARTON / 15 mL in 1 TUBE 2023-05-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Deep Acne 5 mg/100mL 68479-0240-00 Dermalogica, 2 ml — — FDA listed —
Shaant Spot Hero Drying Acne Treatment 50 mg/mLthis 83196-0690-12 Codex 1 tube — — FDA listed —
DRx Blemish Clarifying Mask 50 mg/mL 58633-0704-10 Dr. 1 tube — — FDA listed —
Spot Defy 50 mg/mL 49825-0200-10 Bioelements, 1 bottle — — 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
May 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.

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

  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII 3R504894L9
    A natural extract from birch tree bark used as a binder and thickening agent. It helps hold tablet ingredients together and may improve the product's texture and consistency.
  • UNII 6810070TYD
    Centella asiatica leaf is a plant extract used in medicines as a skin-conditioning agent and natural ingredient. It may help soften or soothe the product's texture and is included for its traditional botanical properties in topical or oral formulations.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII 3RT3536DHY
    A natural plant material derived from coconut that serves as a filler and texturizing agent in medicines. It helps give the product structure and consistency.
  • UNII 63ZP7I1BQO
    A plant-derived thickening agent made from xanthan gum that has been chemically modified. It helps give the medicine the right texture and consistency, and may act as a binder or stabilizer in tablets and liquids.
  • UNII 3W9AY2P26F
    Fucus spiralis is a brown seaweed extract used in medicines as a thickener, binder, and stabilizer to improve texture and help ingredients stay mixed together in the product.
  • 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 0WT12SX38S
    Glycolic acid is an alpha-hydroxy acid derived from sugar cane that helps dissolve and remove dead skin cells. In topical medicines, it works as an exfoliant and pH adjuster to improve skin penetration and product effectiveness.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 1PRR1V42V5
    A beneficial bacterium sometimes added to medicines and supplements. It may serve as a probiotic ingredient intended to support digestive health, though in a medicine it functions mainly as an active component rather than a traditional inactive filler or binder.
  • UNII 817L1N4CKP
    Malic acid is a naturally occurring organic acid found in fruits. It works as a buffer and flavor agent to maintain the medicine's pH balance and add tartness to the product.
  • UNII KRP8S57T49
    A plant oil extracted from holy basil leaves. Used as a flavor agent and fragrance component to enhance the taste and aroma of the medicine.
  • UNII 461N1O614Y
    A synthetic oily liquid used as an emollient and solvent in medications. It helps dissolve active ingredients and improves how the medicine spreads or absorbs through the skin.
  • UNII 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII 2I2A73IYL7
    A plant extract derived from patchouli, used as a fragrance and flavoring agent in medications to improve taste and aroma.
  • 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 5965N8W85T
    Propanediol is a clear liquid organic compound derived from vegetable sources or synthesized chemically. It acts as a humectant to retain moisture, a solvent to dissolve active ingredients, and a preservative booster in liquid medications and supplements.
  • UNII 8558G7RUTR
    Pyruvic acid is an organic compound that acts as a buffer and pH regulator in medicines. It helps maintain the proper acidity level to keep the drug stable and effective during storage.
  • UNII F58HDD7DYH
    A plant-derived compound from milk thistle used as a binder and stabilizer in formulations. It helps hold tablet ingredients together and may improve how the medicine breaks down in the digestive system.
  • 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 TU7HW0W0QT
    A salt derived from lactic acid, sodium lactate acts as a buffer and pH stabilizer in medicines. It helps maintain the product's acidity level and can also serve as a humectant to retain moisture.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII W4888I119H
    Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
  • UNII T9C83Z6363
    A type of marine microalgae used as a natural colorant and nutritional ingredient. It provides green pigmentation and may contribute vitamins and minerals to 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 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII 5JFW9Q62HN
    Zostera marina is seagrass harvested from ocean environments. It's used in medications as a natural binder and thickening agent to help hold ingredients together and improve texture.

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

The official label also statesWater (Aqua), Denatured Alcohol, Lactobacillus Ferment, Propanediol, Glycerin, Silybum Marianum Ethyl Ester, Lactobacillus, Dehydroxanthan Gum, Fucus Spiralis (Spiral Wrack) Extract, Tetraselmis Chui Extract, Centella Asiatica Leaf Extract, Sodium Lactate, Sodium PCA, Malic Acid, Glycolic Acid, Lactic Acid, Pyruvic Acid, Tartaric Acid, Hydrolyzed Sodium Hyaluronate, Sodium Phytate, Ocimum Sanctum Leaf Oil, Octyldodecanol, Pogostemon Cablin (Patchouli) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Xanthan Gum. Eau, Alcool dénaturé, Ferment de lactobacilles, Propanediol, Glycérol, Silybum Marianum ester éthylique, Lactobacillus, Gomme de déhydroxanthane, Fucus Spiralis (Spiral Wrack) Extrait, Extrait de Tetraselmis Chui, Extrait de feuille de Centella Asiatica, Sodium Lactate, Sodium PCA, Acide malique, Acide glycolique, Acide lactique, Acide pyruvique, Acide tartrique, Hyaluronate de sodium hydrolysé, Sodium Phytate, Huile de feuille d'Ocimum Sanctum, Octyldodécanol, Pogostemon Cablin (Patchouli) Extrait de feuille, Cocos Nucifera (noix de coco) Extrait de fruit, Tocophérol, Sodium Benzoate, Potassium Sorbate, Acide citrique, Gomme xanthane.

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

LabelerCodex Labs Corporation
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code83196
First marketedMay 2023
Product typeHuman Otc Drug
Portfolio4 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 📄 When Using This Product 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 183 words ▾

Use For the treatment of acne.

Utiliser Pour le traitement de l'acné. Mises en garde Pour usage externe uniquement. Ne pas utiliser sur lésions cutanées grandes surfaces de la peau Lorsque vous utilisez ce produit appliquer uniquement sur les zones concernées par l'acné l'irritation et la sécheresse peuvent apparaître si vous utilisez un autre médicament topique contre l'acné en même temps.

En cas d'irritation, n'utilisez qu'un seul médicament topique contre l'acné à la fois. éviter le contact avec les yeux. En cas de contact, rincer abondamment à l'eau. Garder hors de portée des enfants.

En cas d'ingestion, consultez un médecin ou contactez immédiatement un centre antipoison. Mode d'emploi Nettoyez soigneusement la peau avant d'appliquer ce produit couvrir toute la zone concernée avec une fine couche 1 à 3 fois par jour si un dessèchement excessif de la peau survient, commencer par 1 application par jour, puis augmenter progressivement à 2 ou 3 fois par jour si nécessaire ou selon les directives d'un médecin en cas de sécheresse ou de desquamation gênante, réduire l'application à une fois par jour ou tous les deux jours.

⏱️ Dosage and Administration 146 words ▾

Directions Clean the skin thoroughly before applying this product cover the entire affected area with a thin layer 1 to 3 times daily because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Mode d'emploi Nettoyez soigneusement la peau avant d'appliquer ce produit couvrir toute la zone concernée avec une fine couche 1 à 3 fois par jour si un dessèchement excessif de la peau survient, commencer par 1 application par jour, puis augmenter progressivement à 2 ou 3 fois par jour si nécessaire ou selon les directives d'un médecin en cas de sécheresse ou de desquamation gênante, réduire l'application à une fois par jour ou tous les deux jours.

⚠️ Warnings 94 words ▾

Warnings For external use only. Do not use on broken skin large areas of the skin When using this product apply only to areas with acne skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use 1 topical acne medication at a time avoid contact with eyes.

If contact occurs, flush thoroughly with water. Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

Mises en garde Pour usage externe uniquement.

🧪 Active Ingredient 8 words ▾

Active ingredient Sulfur 5%

Ingrédient actif Soufre 5%

🧪 Inactive Ingredients 154 words ▾

Inactive ingredients Water (Aqua), Denatured Alcohol, Lactobacillus Ferment, Propanediol, Glycerin, Silybum Marianum Ethyl Ester, Lactobacillus, Dehydroxanthan Gum, Fucus Spiralis (Spiral Wrack) Extract, Tetraselmis Chui Extract, Centella Asiatica Leaf Extract, Sodium Lactate, Sodium PCA, Malic Acid, Glycolic Acid, Lactic Acid, Pyruvic Acid, Tartaric Acid, Hydrolyzed Sodium Hyaluronate, Sodium Phytate, Ocimum Sanctum Leaf Oil, Octyldodecanol, Pogostemon Cablin (Patchouli) Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Tocopherol, Sodium Benzoate, Potassium Sorbate, Citric Acid, Xanthan Gum.

Ingrédients inactifs Eau, Alcool dénaturé, Ferment de lactobacilles, Propanediol, Glycérol, Silybum Marianum ester éthylique, Lactobacillus, Gomme de déhydroxanthane, Fucus Spiralis (Spiral Wrack) Extrait, Extrait de Tetraselmis Chui, Extrait de feuille de Centella Asiatica, Sodium Lactate, Sodium PCA, Acide malique, Acide glycolique, Acide lactique, Acide pyruvique, Acide tartrique, Hyaluronate de sodium hydrolysé, Sodium Phytate, Huile de feuille d'Ocimum Sanctum, Octyldodécanol, Pogostemon Cablin (Patchouli) Extrait de feuille, Cocos Nucifera (noix de coco) Extrait de fruit, Tocophérol, Sodium Benzoate, Potassium Sorbate, Acide citrique, Gomme xanthane.

🎯 Purpose 7 words ▾

Purpose Acne treatment

Utilité Traitement de l'acné

📄 Do Not Use 22 words ▾

Do not use on broken skin large areas of the skin

Ne pas utiliser sur lésions cutanées grandes surfaces de la peau

📄 When Using This Product 111 words ▾

When using this product apply only to areas with acne skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use 1 topical acne medication at a time avoid contact with eyes. If contact occurs, flush thoroughly with water.

Lorsque vous utilisez ce produit appliquer uniquement sur les zones concernées par l'acné l'irritation et la sécheresse peuvent apparaître si vous utilisez un autre médicament topique contre l'acné en même temps. En cas d'irritation, n'utilisez qu'un seul médicament topique contre l'acné à la fois. éviter le contact avec les yeux. En cas de contact, rincer abondamment à l'eau.

📄 Keep Out of Reach of Children 36 words ▾

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

Garder hors de portée des enfants. En cas d'ingestion, consultez un médecin ou contactez immédiatement un centre antipoison.

📄 Questions or Comments 53 words ▾

Questions? Email [email protected] or call 1-855-263-3980 Info-médicament

Questions? Messagerie électronique [email protected] ou composez le 1-855-263-3980 Made in the USA of domestic and imported materials Manufactured for Fabriqué par Codex Labs Corp. San Jose, CA 95124 USA codexlabscorp.com This product is covered by patent(s) or other intellectual property right(s); see codexlabscorp.com/IP for more details.

📄 Package Label / Principal Display Panel 88 words ▾

Principal Display Panel – 15 mL Carton Label CODEX LABS™ SHAANT SPOT HERO Drying Gel Acne Treatment Sulfur 5% Gel de Séchage Traitement de l'acné Soufre 5% STOP BOUTON DERMATOLOGIST TESTED TESTÉ DERMATOLOGIQUEMENT SERIOUSLY SUSTAINABLE SÉRIEUSEMENT DURABLE Principal Display Panel – 15 mL Carton Label

Principal Display Panel – 15 mL Tube Label CODEX LABS™ SHAANT SPOT HERO Drying Gel Sulfur 5% Gel de Séchage Soufre 5% STOP BOUTON NET WT

0.5FL. OZ. / POIDS NET 15 mL e Principal Display Panel – 15 mL Tube Label

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 Shaant Spot Hero Drying Acne Treatment (this brand).

Top reported reactions

Drug Hypersensitivity162
Pain22
Dizziness20
Headache19
Malaise19
Fatigue18
Abdominal Distension16

Reporter sex

339 reports
Male · 22%
Female · 78%
Unknown · 0%

Serious outcomes

Disabling12
Death6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 31 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 Codex Labs Corporation. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Codex Labs Corporation 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.
← 83196-0676-12 · Codex 83196-0785-12 · Codex →
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.