NDC 00574-0521-76 — ACTIDOSE AQUA activated charcoal 208 mg/mL

🆔 Identity & classification

FDA NDC (as labeled) 0574-0521-76

Product NDC 0574-0521

11-digit billing NDC 00574052176

NCPDP billing unit ML — per mL (volume)

RxCUI 309150, 1251411

UNII 2P3VWU3H10

Application # M023

SPL Set ID c85dc235-3f42-4361-9bd2-1aaff798ad75

DEA schedule Non-controlled

Marketing category OTC MONOGRAPH DRUG

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2020-11-10

Route ORAL

Dosage form SUSPENSION

Substance ACTIVATED CHARCOAL

GCN Seq No 057765

GCN 22994

HICL code 001117

Ingredient (HICL) Activated Charcoal

HIC1 code C

Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition

HIC2 code C8

Therapeutic class — intermediate (HIC2) Antidotes To Poisons

HIC3 code C8E

Therapeutic class — specific (HIC3) Antidotes,Miscellaneous

AHFS code 56:04.00.00

AHFS class Antacids And Adsorbents

FDB label name ACTIDOSE-AQUA 50 GM/240 ML LIQ

FDB brand name Actidose-Aqua

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0574-0521-76 — 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 → 00574-0521-76. 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 Charcoal preparations class.

Drug family (ATC) Charcoal preparations

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.

🏭 Manufacturer & labeler

LabelerPadagis US LLC

FDA applicationM023 (OTC MONOGRAPH DRUG)

Labeler code00574

First marketedNov 2020

Product typeHuman Otc Drug

Portfolio63 products on file

🔎 All NDCs from Padagis US LLC

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.

🩺 Clinical

Label name ACTIDOSE-AQUA 50 GM/240 ML LIQ Ingredient Activated Charcoal

🧪 What is this product?

Actidose Aqua is an over-the-counter liquid suspension containing activated charcoal that is taken by mouth. Activated charcoal is commonly used in emergency and poison-control settings to help bind certain ingested substances in the stomach and prevent their absorption into the bloodstream. This product is marketed as an OTC monograph drug, meaning it follows established safety and use guidelines for its category rather than undergoing individual FDA review.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

🧪 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 XF417D3PSL
Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
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 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule 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.

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

The official label also statesCitric acid, glycerin, propylene glycol, sucrose, and water.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$35.74	$8,576.52 / 240 ml
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Actidose 208 mg/mL 00574-0520-04	Padagis	120 ml	—	—	FDA listed	—
Actidose Aqua 208 mg/mLthis 00574-0521-76	Padagis	240 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

🏛️

2020

On the market since

Nov 2020

📍

2026

Currently FDA-listed

6 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.

🗺️ 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 00574-0521-76, 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

40

Units reimbursed last 4 qtrs

87

Gross reimbursed last 4 qtrs

$3.1K

Avg / prescription

$77.72

Avg / unit

$35.7355

Latest quarter Q4 2025

0Rx

Fee-for-service vs managed care ⓘ

100% MCO

Fee-for-service · 0 Rx Managed care · 40 Rx

State Medicaid map

Units reimbursed · per 100k residents

1.91.9

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 Kentucky 1.9 /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.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

24 ml this page00574-0521-76 40 Rx · $3,109

12 ml00574-0521-04 No Medicaid data

24 ml00574-0521-08 No Medicaid data

12 ml00574-0521-74 No Medicaid data

72 ml00574-0521-25 No Medicaid data

Drug total (last 4 qtrs): 40 Rx · 87 units · $3,109 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 ACTIDOSE AQUA (this brand).

Top reported reactions

Overdose164

Toxicity To Various Agents133

Intentional Overdose101

Intentional Product Misuse98

Drug Abuse93

Rash86

Abdominal Discomfort85

Reporter sex

Serious outcomes

Life-threatening188

Death173

Disabling52

Reports over time (by year) — tap or hover for the count & year

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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
00574-0521-04	120 mL in 1 BOTTLE (0574-0521-04)	2020-11-11	Active
00574-0521-08	240 mL in 1 BOTTLE (0574-0521-08)	2020-11-11	Active
00574-0521-74	120 mL in 1 TUBE (0574-0521-74)	2020-11-10	Active
00574-0521-76 You're viewing this	240 mL in 1 TUBE (0574-0521-76)	2020-12-13	Active
00574-0521-25	72 mL in 1 TUBE (0574-0521-25)	2023-01-31	Active

Pack size FAQ

What quantity is in NDC 00574-0521-76?

NDC 00574-0521-76 contains 240 mL — 240 ml in 1 tube.

What is the difference between NDC 00574-0521-76 and NDC 00574-0521-25?

Both are ACTIDOSE AQUA activated charcoal 208 mg/mL Suspension — the drug itself is identical. NDC 00574-0521-76 is the 240 mL package, while NDC 00574-0521-25 is the 72 ml package.

What NDC number is used to bill for this package of ACTIDOSE AQUA activated charcoal 208 mg/mL Suspension?

Bill NDC 00574-0521-76 — the 11-digit billing format is 00574052176. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ 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.

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 FDA registers it as 0574-0521-76, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 00574-0521-76, written without dashes as 00574052176. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 00574-0521-76, the first segment (00574) is the labeler code FDA assigned to Padagis US LLC; the middle segment (0521) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (76) identifies this exact package size and type. Together they name one specific package of one specific product.

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 Padagis US LLC. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 4 other package presentations of this same product, including 72 ml (00574-0521-25), 120 ml (00574-0521-04), 120 ml (00574-0521-74). 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?

Padagis US LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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

🎯 Indications and Usage 9 words ▾

Uses • For emergency use to adsorb swallowed poisons.

⏱️ Dosage and Administration 112 words ▾

Directions Oral Dosage: 20 to 30 grams of activated charcoal in a minimum of 8 ounces of liquid or as directed by a health professional. Repeat dose immediately, if possible. • Shake well • Snip tapered tip as indicated in drawing and remove. Holding the tube upright, carefully cut off tube closure.

Reattach tapered tip and connect to any charcoal administration set or squeeze contents in a cup with a minimum of 4 ounces of liquid for patient to drink. • If previous attempts to contact a poison control center, emergency medical facility, or health professional were unsuccessful, continue trying. • Keep patient active and moving. • Save the container of poison.

⚠️ Warnings 69 words ▾

Warnings • Do not give activated charcoal until after the patient has vomited unless directed by a health professional. • Do not use in persons who are not fully conscious. • Do not use this product, unless directed by a health professional, if turpentine, corrosives (such as alkalies (lye) and strong acids), or petroleum distillates (such as kerosene, gasoline, paint thinner, cleaning fluid, or furniture polish), have been ingested.

📦 Storage and Handling 15 words ▾

Other information • Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Do not refrigerate.

🧪 Active Ingredient 7 words ▾

Active ingredient (in each tube) Activated Charcoal

🧪 Inactive Ingredients 10 words ▾

Inactive Ingredients Citric acid, glycerin, propylene glycol, sucrose, and water.

🎯 Purpose 3 words ▾

Purpose Poison Adsorbent

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

🔗 Related NDC lookups

🧪 All Activated Charcoal NDCsSame ingredient 🏭 All Padagis labeler NDCsLabeler code 00574

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antidotes,Miscellaneous.

Acetylcysteine 00143-9433-04 Fomepizole 00517-0710-01 Activated Charcoal/Sorbitol 00574-0520-04 Hydroxocobalamin 11704-0370-01 Digoxin Immune Fab 50633-0120-11 Sodium Nitrite 60267-0311-10

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

ACTIDOSE AQUA activated charcoal 208 mg/mL Suspension, 240 mL

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🗺️ Medicaid utilization & spend

💊 Medicaid utilization by pack size

🔬 Reported adverse events (FAERS)

Top reported reactions

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

Pack size FAQ

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups

💊 Related drugs in this class