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Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate 1347 mg; 952 mg Powder, For Solution, 12-count — NDC 16864-0240-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate 1347 mg; 952 mg Powder, For Solution, 12-count — NDC 16864-240-01 (Billing 16864-0240-01) · Product 16864-240

by Advantice Health, LLC. · 12 POWDER, FOR SOLUTION in 1 BOX (16864-240-01)

NDC 16864-240-01 (billing 16864-0240-01) is a package of 12 powders of Domeboro Aluminum Sulfate Tetradecahydrate, Calcium Acetate Monohydrate 1347 mg; 952 mg Powder, For Solution from Advantice Health, LLC., marketed since Jun 2012 and currently FDA-listed. It is the main listing for product NDC 16864-240, its only package size.

NDC 16864-0240-01
🏷️ FDA NDC (as labeled) 16864-240-01 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 16864-240-01
Product NDC 16864-240
11-digit billing NDC 16864024001
NCPDP billing unit EA — each (per item)
RxCUI 1250234, 1293268
UNII E3UT66504P, 7ZA48GIM5H
Application # M016
SPL Set ID 28c39200-2f7c-954b-3ce7-7349b2738812
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-06-26
Route TOPICAL
Dosage form POWDER, FOR SOLUTION
Substance ALUMINUM SULFATE TETRADECAHYDRATE; CALCIUM ACETATE MONOHYDRATE

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

GCN Seq No 068915
GCN 31828
HICL code 003055
Ingredient (HICL) Calcium Acetate/Aluminum Sulf
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 Q5A
Therapeutic class — specific (HIC3) Topical Preparations,Miscellaneous
AHFS code 84:12.00.00
AHFS class Astringents (84:12)
FDB label name DOMEBORO POWDER PACKET
FDB brand name Domeboro
Legend status O — Over-the-counter (OTC) drug or device
Quick answers for NDC 16864-240-01
  • GSN (GCN sequence number): 068915
  • GCN: 31828
  • HICL (First Databank): 003055
  • AHFS class code: 84:12.00.00
  • RxCUI (RxNorm): 1250234
  • 11-digit billing NDC: 16864024001
Why two NDCs? The FDA registers this code as 16864-240-01 — 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 → 16864-0240-01. 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.

Clinical

Label name DOMEBORO POWDER PACKET Ingredient Calcium Acetate/Aluminum Sulf
🧪 What is this product?

Domeboro is an over-the-counter topical powder meant to be mixed with water and applied to the skin. It contains aluminum sulfate and calcium acetate, salts that are typically used together in astringent soaks and compresses. These ingredients are commonly used to help relieve itching, inflammation, and weeping from minor skin conditions such as insect bites, eczema, and poison ivy. This product is marketed as an OTC monograph drug under FDA regulations for its category.

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
16864-0240-01 16864-240-01 You're viewing this Main listing 12 POWDER, FOR SOLUTION in 1 BOX (16864-240-01) 2012-06-26 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Kerasal Athletes Foot Rapid Symptom Relief Medicated Soak 1347 mg/1; 952 mg 16864-0140-01 Advantice 12 powders — — FDA listed —
Domeboro 1347 mg/1; 952 mgthis 16864-0240-01 Advantice 12 powders — — FDA listed —
Astringent 952 mg/2299mg; 1347 mg/2299mg 63561-0178-02 Granulation 12 packets — — FDA listed —
Astringent Solution 952 mg/2299mg; 1347 mg/2299mg 81469-0999-12 First 12 packets — — 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

🏛️
2012
On the market since
Jun 2012
📍
2026
Currently FDA-listed
14 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

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

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAdvantice Health, LLC.
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code16864
First marketedJun 2012
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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses temporarily relieves minor skin irritations due to: poison ivy poison oak poison sumac insect bites athlete's foot rashes caused by soaps, detergents, cosmetics, or jewelry

⏱️ Dosage and Administration 124 words ▾

Directions dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3 packets) aluminum acetate and is ready for use. For use as a soak: soak affected area for 15 to 30 minutes as needed, or as directed by a doctor repeat 3 times a day or as directed by a doctor discard solution after each use For use as a compress or wet dressing: soak a clean, soft cloth in the solution apply cloth loosely to affected area for 15 to 30 minutes repeat as needed or as directed by a doctor discard solution after each use

⚠️ Warnings 77 words ▾

Warnings For external use only When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. do not cover compress or wet dressing with plastic to prevent evaporation in some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 6 words ▾

Other information protect from excessive heat

🧪 Active Ingredient 33 words ▾

Active Ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent* Calcium acetate monohydrate, 952 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.

🧪 Inactive Ingredients 3 words ▾

Inactive ingredients dextrin

🎯 Purpose 33 words ▾

Active Ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent* Calcium acetate monohydrate, 952 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.

📄 When Using This Product 36 words ▾

When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. do not cover compress or wet dressing with plastic to prevent evaporation in some skin conditions, soaking too long may overdry

📄 Stop Use and Ask a Doctor If 17 words ▾

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days

📄 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 5 words ▾

Questions or comments? 1-800-345-0032 www.domeboro.com

📄 Package Label / Principal Display Panel 71 words ▾

PRINCIPAL DISPLAY PANEL - 12 Packet Box DOCTOR RECOMMENDED DOMEBORO ® Aluminum Sulfate Tetradecahydrate / Calcium Acetate Monohydrate-Astringent Burow's Solution Relief Since 1958 CALMING & SOOTHING Medicated Soak RASH RELIEF PLUS DRYING ACTION EFFECTIVE FOR POISON IVY, OAK, SUMAC & OTHER RASHES Dries Oozing Rashes Relieves Itching & Burning Reduces Blistering 12 POWDER PACKETS RELIEF AT LAST NET WT

0.1OZ (2.7 G) EACH PRINCIPAL DISPLAY PANEL - 12 Packet Box

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 Domeboro (this brand).

Top reported reactions

Renal Failure5
Dizziness4
Rash4
Sinusitis4
Asthenia3
Atrial Fibrillation3
Back Pain3

Age at onset

Adult4
Elderly5

Reporter sex

59 reports
Male · 45%
Female · 55%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 FDA registers it as 16864-240-01, 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: 16864-0240-01, written without dashes as 16864024001. 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 16864-0240-01, the first segment (16864) is the labeler code FDA assigned to Advantice Health, LLC.; the middle segment (0240) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Advantice Health, LLC.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Advantice Health, 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.
← 16864-0140-01 · Advantice 16864-0440-01 · Advantice →
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.