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OGEE CLEARGANICS TARGETED BLEMISH TREATMENT Salicylic Acid Acne Medication .5 g/100mL Solution, 10 mL — NDC 84261-0154-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

OGEE CLEARGANICS TARGETED BLEMISH TREATMENT Salicylic Acid Acne Medication .5 g/100mL Solution, 10 mL — NDC 84261-154-01 (Billing 84261-0154-01)

by Ogee Inc · 10 mL in 1 BOTTLE

This is a package of 10 mL of OGEE CLEARGANICS TARGETED BLEMISH TREATMENT Salicylic Acid Acne Medication .5 g/100mL Solution from Ogee Inc, marketed since Apr 2024 and currently FDA-listed. It is this product's only package size.

NDC 84261-0154-01
🏷️ FDA NDC (as labeled) 84261-154-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 84261-154-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
84261 labeler · 154 product · 01 package
Package marketed since
Apr 11, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8426115401 7
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 84261-154-01
Product NDC 84261-154
11-digit billing NDC 84261015401
RxCUI 199308
UNII O414PZ4LPZ
Application # M006
SPL Set ID 162831d3-7e95-62f4-e063-6394a90aef7c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-04-11
Route TOPICAL
Dosage form SOLUTION
Substance SALICYLIC ACID
Quick answers
  • RxCUI (RxNorm): 199308
Why two NDCs? The FDA registers this code as 84261-154-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 84261-0154-01. 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 Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
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

📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical 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 mLPer 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
84261-0154-01 You're viewing this Main listing 10 mL in 1 BOTTLE 2024-04-11 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cetaphil Gentle Clear Triple-Action Acne Serum 5 mg/mL 00299-4135-00 Galderma 1 tube — — FDA listed —
Oxy Total Care Vitamin C Serum 5 mg/mL 10742-1315-01 The 1 vial — — FDA listed —
Up and Up Deep Clean Toner 5 mg/mL 11673-0936-11 TARGET 236.5 ml — — FDA listed —
Salicylic Acid 5 mg/mL 36800-0875-34 Topco 237 ml — — FDA listed —
Even Better Clinical Acne Solutions 5 mg/mL 49527-0114-01 CLINIQUE 1 bottle — — FDA listed —
ACNE solutions liquid MAKEUP SALICYLIC ACID ACNE TREATMENT 5 mg/mL 49527-0751-01 CLINIQUE 1 bottle — — Discontinued —
La Roche Posay Laboratoire Dermatologique Effaclar Clarifying 5 mg/mL 49967-0024-01 L'Oreal 200 ml — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment 5 mg/mL 49967-0068-01 L'Oreal 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 49967-0926-01 L'Oreal 1 tube — — FDA listed —
Salicylic Acid 5 mg/mL 55301-0875-34 Your 237 ml — — Discontinued —
Nutricentials Here You Glow Exfoliating Toner 5 mg/mL 62839-1339-01 NSE 150 ml — — FDA listed —
Clear Smart Clear Complexion Toner .5 g/100mL 68828-0289-01 Distribuidora 200 ml — — FDA listed —
In the Clear Acne Serum .5 g/100mL 69366-0414-31 The 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 69625-0058-01 COSMETIQUE 15 tubes — — FDA listed —
SkinCeuticals Silymarin CF Acne Treatment Antioxidant 5 mg/mL 69625-0069-01 Cosmetique 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M Multi Target Acne Treatment 5 mg/mL 69625-0926-01 COSMETIQUE 1 tube — — FDA listed —
Neutrogena Skin Clearing Blemish Concealer - Deep 20 5 mg/g 69968-0338-01 Kenvue 1 vial — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10 5 mg/mL 69968-0853-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Ivory 20 5 mg/mL 69968-0854-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Buff 30 5 mg/mL 69968-0855-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Nude 40 5 mg/mL 69968-0856-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Soft Beige 50 5 mg/mL 69968-0857-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Natural Beige 60 5 mg/mL 69968-0858-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Fresh Beige 70 5 mg/mL 69968-0859-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Medium Beige 80 5 mg/mL 69968-0860-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Honey 85 5 mg/mL 69968-0861-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Warm Beige 90 5 mg/mL 69968-0862-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup- Natural Tan 100 5 mg/mL 69968-0863-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Caramel 105 5 mg/mL 69968-0864-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Cocoa 115 5 mg/mL 69968-0865-01 Kenvue 30 ml — — FDA listed —
Neutrogena SkinClearing Oil-Free Makeup - Chestnut 135 5 mg/mL 69968-0866-01 Kenvue 30 ml — — FDA listed —
Clearsynergy .25 g/50mL 71617-0100-10 SRL 1 bottle — — FDA listed —
FHF Crisp Start .5 g/100g 72788-0151-03 Summer 1 tube — — FDA listed —
Dr. C. Tuna Acne Pore Purifying Toner 5 mg/mL 74690-0009-01 Farmasi 1 bottle — — FDA listed —
La Roche Posay Laboratoire Dermatologique Effaclar Duo Plus M MultiTarget Acne Treatment 5 mg/mL 82046-0058-01 L'Oreal 15 tubes — — FDA listed —
Ogee Clearganics Targeted Blemish Treatment .5 g/100mLthis 84261-0154-01 Ogee 10 ml — — 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

🏛️
2024
On the market since
Apr 2024
📍
2026
Currently FDA-listed
2 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 Salicylic Acid Topical 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 S95658MI3W
    A carbohydrate derived from starch that acts as a binder and filler in tablets and capsules. It helps hold ingredients together and adds bulk to the medicine so it's easier to manufacture and handle.
  • UNII 7QY1MH15BG
    A synthetic organic compound used as a flavoring agent in medicines. It provides a mild, pleasant taste to mask bitter drug flavors and improve patient acceptance of oral formulations.
  • 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 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 94ZLA3W45F
    Arginine is an amino acid used in medicines as a buffer and pH adjuster. It helps maintain the proper acidity level and stability of liquid formulations.
  • UNII 3TE8A92UPM
    Azadirachta indica flower is a botanical extract from the neem plant. It may be used in formulations for its traditional preservative or antioxidant properties to help maintain product stability.
  • UNII HKY915780T
    A plant extract from the neem tree, used as a natural flavoring agent and preservative in medicines. It may help maintain product stability and add bitter taste characteristics.
  • UNII X1Q40X9I5L
    A plant extract from the embelia ribes fruit, used as a natural flavoring or taste-masking agent in medicines. It may help improve the palatability of oral formulations.
  • UNII 1340BFH77T
    A plant extract from the mangosteen fruit rind, used as a natural coloring agent or flavoring ingredient in medicines. It may also contribute antioxidant properties to help preserve product stability.
  • 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 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 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • UNII JOS53KRJ01
    Inulin is a fiber derived from plants like chicory root. It acts as a filler and binder in medicines to add bulk and help hold tablets together.
  • UNII 724GKU717M
    Jojoba oil is a natural liquid wax extracted from jojoba plant seeds. It's used in medicines as an emollient and lubricant to soften and smooth the product, and sometimes as a carrier or penetration enhancer.
  • 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 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII ML9LGA7468
    A naturally-derived alcohol used as a preservative and fragrance in medicines. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII MPJ2Q8WI8G
    A plant-derived emulsifier made from glycerin and lauric acid. It helps mix oil and water-based ingredients together and improves product texture and stability in formulations.
  • 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 R6Q3791S76
    Sodium gluconate is a salt derived from gluconic acid, a naturally occurring compound. In medicines, it functions as a buffering agent to help maintain stable pH and as a chelating agent that can bind minerals in formulations.
  • UNII GH42T47V24
    A plant extract from tea leaves that acts as an antioxidant and flavor ingredient. It helps preserve the medicine and improve its taste.
  • 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.

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

The official label also statesAqua/Water/Eau, Alcohol Denat* (†Sugarcane), Aloe Barbadensis (Aloe Vera) Leaf Juice*, Alpha-Glucan Oligosaccharide (†Vegetable Sources), Arginine (†Sugar), Boswellia Serrata (Frankincense) Resin Extract, Camellia Sinensis (Tea) Leaf Extract, Embelia Concinna (Hug of the Forest) Leaf Extract, Garcinia Mangostana (Mangosteen) Peel Extract, Glycerin (†Rapeseed), Inulin (†Plant), Lactic Acid (†Fermentation of Sugar), Melia Azadirachta (Indian Lilac) Flower Extract, Melia Azadirachta (Indian Lilac) Leaf Extract, Pentylene Glycol (†Sugarcane), Phenethyl Alcohol (†Corn), Polyglyceryl-10 Laurate (†Vegetable Sources), Propanediol (†Corn), Raspberry Ketone, Simmondsia Chinensis (Jojoba) Seed Oil*, Sodium Gluconate (†Fermentation of Sugar), Sodium Hyaluronate (Hyaluronic Acid †Fermentation), Tocopherol (†Vegetable Sources), Xanthan Gum (†Fermentation). *Organic Ingredient †Derived From

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

LabelerOgee Inc
FDA applicationM006 (OTC MONOGRAPH DRUG)
Labeler code84261
First marketedApr 2024
Product typeHuman Otc Drug
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 and Cautions ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Uses For the treatment of acne.

⏱️ Dosage and Administration 78 words ▾

Directions ■ Apply directly to active breakouts on skin. ■ Apply enough product to cover. Apply gentle pressure in a massaging motion to soothe the breakout. ■ However, do not over-irritate skin with excessive rubbing or pressure. ■ Because all skin responds differently to treatment, start with a small application on an inconspicuous area, and then gradually increase to desired frequency. ■ If bothersome reaction or appearance occurs, reduce application frequency to once a day or discontinue use.

⚠️ Warnings and Cautions 12 words ▾

Other Information Avoid storage in extreme temperature conditions of hot or cold.

⚠️ Warnings 117 words ▾

Warnings ■For external use only. ■Keep out of eyes. Do not use if you are sensitive to Salicylic Acid. When using this product ■ using other topical acne medication while or immediately following use of this product may increase dryness or irritation of the skin. ■ If irritation occurs, reduce frequency and/or dose and consider discontinuing use. ■ Avoid contact with fabric, which may become discolored.

Stop using and consult a doctor if irritation persists or becomes severe. Do not ingest. Keep out of reach of children.

If swallowed, seek medical attention and contact a Poison Control Center immediately. Keep out of reach of children. If swallowed, seek medical attention and contact a Poison Control Center immediately.

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid 0.5%

🧪 Inactive Ingredients 101 words ▾

Inactive ingredients Aqua/Water/Eau, Alcohol Denat* (†Sugarcane), Aloe Barbadensis (Aloe Vera) Leaf Juice*, Alpha-Glucan Oligosaccharide (†Vegetable Sources), Arginine (†Sugar), Boswellia Serrata (Frankincense) Resin Extract, Camellia Sinensis (Tea) Leaf Extract, Embelia Concinna (Hug of the Forest) Leaf Extract, Garcinia Mangostana (Mangosteen) Peel Extract, Glycerin (†Rapeseed), Inulin (†Plant), Lactic Acid (†Fermentation of Sugar), Melia Azadirachta (Indian Lilac) Flower Extract, Melia Azadirachta (Indian Lilac) Leaf Extract, Pentylene Glycol (†Sugarcane), Phenethyl Alcohol (†Corn), Polyglyceryl-10 Laurate (†Vegetable Sources), Propanediol (†Corn), Raspberry Ketone, Simmondsia Chinensis (Jojoba) Seed Oil*, Sodium Gluconate (†Fermentation of Sugar), Sodium Hyaluronate (Hyaluronic Acid †Fermentation), Tocopherol (†Vegetable Sources), Xanthan Gum (†Fermentation). *Organic Ingredient †Derived From

🎯 Purpose 3 words ▾

Purpose Acne Medication

📄 Keep Out of Reach of Children 18 words ▾

Keep out of reach of children. If swallowed, seek medical attention and contact a Poison Control Center immediately.

📄 Questions or Comments 5 words ▾

Questions Call 888-376-8037 or ogee.com

📄 Package Label / Principal Display Panel 143 words ▾

Principal Display Panel OGEE CLEARGANICS TARGETED BLEMISH TREATMENT CONTAINS ORGANIC INGREDIENTS CLARIFYING ACNE SOLUTION 10 ml / 0.3 fl. oz. A powerful plant-based Salicylic Acid spot treatment that works to control acne and prevent the development of new blemishes. Infused with a skin-soothing blend of Tea and Frankincense Extracts to soften the appearance of inflammation and redness.

Directions: Using the soothing ceramic tip, apply directly to active breakouts on skin. See Drug Facts for more. Keep away from heat.

Contains Organic Ingredients Made in USA with Globally-Sourced, High-Performance Ingredients Distributed by Ogee, Inc. Burlington, Vermont 05401 ogee.com Certified to NSF/ANSI 305 by QAI OGEE and CLEARGANICS are trademarks of Ogee, Inc. EU/UK RP: TRC 2511 VJ NL / TRC UK EC2V 6AA UK © All rights reserved.

2024 Contains Organic Ingredients Cruelty Free Beyond Clean Beauty No Gluten Added GMO Free Vegan LABEL

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

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 Ogee Inc. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Ogee 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.
← 84260-0011-01 · Guangzhou 84262-0027-01 · Glytone, →
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.