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Benzoin Compound Tincture Benzoin Resin 1000 mg/mL Liquid, 473 mL — NDC 00395-0243-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Benzoin Compound Tincture Benzoin Resin 1000 mg/mL Liquid, 473 mL — NDC 0395-0243-16 (Billing 00395-0243-16)

by Humco Holding Group, Inc. · 473 mL in 1 BOTTLE, PLASTIC

This is a package of 473 mL of Benzoin Compound Tincture Benzoin Resin 1000 mg/mL Liquid from Humco Holding Group, Inc., marketed since Jan 2008 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00395-0243-16
🏷️ FDA NDC (as labeled) 0395-0243-16 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes2 compare ↓
Main listing for product 0395-0243 · Also comes in: 59 ml 0395-0243-92
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 0395-0243-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0395 labeler · 0243 product · 16 package
Package marketed since
Nov 10, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
473 mL per package
Barcode (UPC)
0303950243160, 0303950243924
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-0243-16
Product NDC 0395-0243
11-digit billing NDC 00395024316
NCPDP billing unit ML — per mL (volume)
UNII GK21SBA74R
UPC 0303950243160, 0303950243924
Application # M022
SPL Set ID a893a232-2ea8-4e0d-8cbf-7f5040b3be2e
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2008-01-01
Route TOPICAL
Dosage form LIQUID
Substance BENZOIN RESIN

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

GPI-14 90972010101500
GPI class Benzoin Compound
GCN Seq No 062763
GCN 98537
HICL code 024460
Ingredient (HICL) Benzoin/Aloe Vera/Storax/Tolu
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 84:24.12.00
AHFS class Basic Ointments And Protectants
FDB label name BENZOIN COMPOUND TINCTURE
FDB brand name Benzoin Compound
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 062763
  • GCN: 98537
  • GPI-14 (Medi-Span): 90972010101500
  • HICL (First Databank): 024460
  • AHFS class code: 84:24.12.00
Why two NDCs? The FDA registers this code as 0395-0243-16 — 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 → 00395-0243-16. 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 BENZOIN COMPOUND TINCTURE Ingredient Benzoin/Aloe Vera/Storax/Tolu
🧪 What is this product?

This is a topical liquid preparation containing benzoin resin, marketed as an over-the-counter monograph drug. Benzoin resin is a plant-derived ingredient typically used in topical products for its astringent and mild antimicrobial properties. Products containing benzoin are commonly applied to skin for soothing minor cuts, scrapes, and irritations, and the resin may also be used as a protective coating on wound dressings.

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.
Try another pack size: 59 ml
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
00395-0243-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2017-11-10 — Active
00395-0243-92 0395-0243-92 59 mL in 1 BOTTLE, PLASTIC 2017-11-10 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 473 mL — 473 ml in 1 bottle, plastic.
How does this package differ from NDC 00395-0243-92?
Both are Benzoin Compound Tincture Benzoin Resin 1000 mg/mL Liquid — the drug itself is identical. This page's package is the 473 mL one, while NDC 00395-0243-92 is the 59 ml package.
What NDC number is used to bill for this package of Benzoin Compound Tincture Benzoin Resin 1000 mg/mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Benzoin Tincture 1000 mg/mL 00395-0247-92 Humco 59 ml — — FDA listed —
Sunmark Benzoin Compound Tincture 1000 mg/mL 49348-0138-30 Strategic 59 ml — — FDA listed —
Benzoin Tincture 1000 mg/mL 82645-0924-92 Pharma 59 ml — — FDA listed —
Benzoin Tincture 1000 mg/mL 70677-1200-01 116956644 59 ml — — FDA listed —
Benzoin Compound Tincture 1000 mg/mLthis 00395-0243-16 Humco 473 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

🏛️
2008
On the market since
Jan 2008
📍
2026
Currently FDA-listed
18 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 V5VD430YW9
    A plant-derived substance from the aloe vera leaf. Used in medicines as a natural flavor, skin-soothing agent in topical products, and sometimes as a mild laxative ingredient in oral formulations.
  • UNII TD2LE91MBE
    Tolu balsam is a resinous substance from a South American tree used as a flavoring agent and mild preservative in medications. It adds pleasant taste and aroma while helping maintain product stability.

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

The official label also statesAlcohol 77%, Aloe, Storax, Tolu Balsam

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

LabelerHumco Holding Group, Inc.
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedJan 2008
Product typeHuman Otc Drug
Portfolio35 products on file

More NDCs from Humco Holding Group, Inc. labeler code 00395

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use Forms a coating over wound for protecting recurring canker sores

⏱️ Dosage and Administration 41 words ▾

Directions Adults and children 6 months of age and older: Dry the affected area, with cotton swab, apply undiluted to the affected area not more often than every 2 hours. Children under 6 months of age: Consult a dentist or doctor.

⚠️ Warnings 13 words ▾

Warnings For external use only. Do not swallow. Do not exceed recommended dosage.

🧪 Active Ingredient 3 words ▾

Active Ingredient Benzoin

🧪 Inactive Ingredients 8 words ▾

Inactive Ingredients Alcohol 77%, Aloe, Storax, Tolu Balsam

🎯 Purpose 4 words ▾

Purpose Oral mucosal protectant

📄 When Using This Product 34 words ▾

When using this product Children under 12 years of age should be supervised in the use of this product. Do not use for more than 7 days unless directed by a dentist or doctor.

📄 Stop Use and Ask a Doctor If 30 words ▾

Stop use and consult a dentist or doctor if sore mouth symptoms do not improve in 7 days. irritation, pain or redness persists or worsens. swelling, rash or fever develops.

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

📄 Other Information 10 words ▾

Other information Flammable: Keep away from spark, heat or flame.

📄 Package Label / Principal Display Panel 26 words ▾

Principal Display Panel - 16oz Benz16.jpg 16 oz

Principal Display Panel - 2 oz Benz.jpg new label 2 oz

2025 Label Update Humco Benzoin Compound 2025

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 Benzoin Resin — the ingredient across all brands.

Top reported reactions

Anaphylactic Reaction3
Hypersensitivity3
Cardiac Arrest2
Dermatitis2
Pulseless Electrical Activity2
Rash2
Urticaria2

Age at onset

Adult1

Reporter sex

13 reports
Male · 64%
Female · 36%

Serious outcomes

Life-threatening3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2 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 Humco Holding Group, Inc.. 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 1 other package presentation of this same product, including 59 ml (00395-0243-92). 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?
Humco Holding Group, 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.
← 00395-0098-91 · Humco 00395-0247-92 · Humco →
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.