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Humco Hydrogen Peroxide Hydrogen Peroxide 3% 30 mg/mL Liquid, 473 mL — NDC 00395-1113-16 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Humco Hydrogen Peroxide Hydrogen Peroxide 3% 30 mg/mL Liquid, 473 mL — NDC 0395-1113-16 (Billing 00395-1113-16)

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

This is a package of 473 mL of Humco Hydrogen Peroxide Hydrogen Peroxide 3% 30 mg/mL Liquid from Humco Holding Group, Inc., marketed since Mar 1998 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 00395-1113-16
🏷️ FDA NDC (as labeled) 0395-1113-16 billing pads the labeler segment with a zero
This package
Contains473 mL Pack sizes3 compare ↓
Main listing for product 0395-1113 · Also comes in: 113 ml 0395-1113-94 3800 ml 0395-1113-28
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 0395-1113-16 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0395 labeler · 1113 product · 16 package
Package marketed since
Oct 30, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0303951113165
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0395-1113-16
Product NDC 0395-1113
11-digit billing NDC 00395111316
RxCUI 91349
UNII BBX060AN9V
UPC 0303951113165
Application # M003
SPL Set ID 2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1998-03-25
Route TOPICAL
Dosage form LIQUID
Substance HYDROGEN PEROXIDE

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

GPI-14 92000020002010
GPI class Hydrogen Peroxide
GCN Seq No 009801
GCN 45121
HICL code 004267
Ingredient (HICL) Hydrogen Peroxide
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W8
Therapeutic class — intermediate (HIC2) Antiseptics
HIC3 code W8D
Therapeutic class — specific (HIC3) Oxidizing Agents
AHFS code 52:28.00.00
AHFS class Mouthwashes And Gargles
FDB label name HYDROGEN PEROXIDE 3% SOLN
FDB brand name Hydrogen Peroxide
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 009801
  • GCN: 45121
  • GPI-14 (Medi-Span): 92000020002010
  • HICL (First Databank): 004267
  • AHFS class code: 52:28.00.00
  • RxCUI (RxNorm): 91349
Why two NDCs? The FDA registers this code as 0395-1113-16 — 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 → 00395-1113-16. 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.

RxNorm drug class

This medicine belongs to the Antiinfectives and antiseptics for local oral treatment class.

Drug family (ATC) Antiinfectives and antiseptics for local oral treatment, Other antiseptics and disinfectants, Other dermatologicals
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

Label name HYDROGEN PEROXIDE 3% SOLN Ingredient Hydrogen Peroxide
🧪 What is this product?

Humco Hydrogen Peroxide is a 3% liquid solution applied to the skin as an over-the-counter monograph drug. Hydrogen peroxide is typically used as a topical cleanser and mild antiseptic for minor cuts, scrapes, and wound care. The product works by releasing oxygen when it contacts organic matter, which helps remove debris and reduce bacteria in small skin injuries. This is a non-prescription OTC monograph product marketed under FDA's established category rules for hydrogen peroxide solutions.

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: 113 ml 3800 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
00395-1113-16 You're viewing this Main listing 473 mL in 1 BOTTLE, PLASTIC 2017-10-30 — Active
00395-1113-28 0395-1113-28 3800 mL in 1 BOTTLE, PLASTIC 2017-10-30 — Active
00395-1113-94 0395-1113-94 113 mL in 1 BOTTLE, PLASTIC 2017-10-30 — Active

You're viewing one of 3 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 00395-1113-94?
Both are Humco Hydrogen Peroxide Hydrogen Peroxide 3% 30 mg/mL Liquid — the drug itself is identical. This page's package is the 473 mL one, while NDC 00395-1113-94 is the 113 ml package.
What NDC number is used to bill for this package of Humco Hydrogen Peroxide Hydrogen Peroxide 3% 30 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
Hydrogen Peroxide 3 Percent 3 mL/100mL 70000-0500-01 Cardinal 946 ml $0.002 — Availability likely —
Sunmark Hydrogen Peroxide 3 Percent 30 mg/mL 49348-0179-34 Strategic 118 ml $0.005 — FDA listed —
Health Mart Hydrogen Peroxide 3 Percent 30 mg/mL 62011-0267-01 Strategic 118 ml $0.005 — FDA listed —
Hydrogen Peroxide 30 mg/mL 68599-2301-02 McKesson 118 ml $0.005 — FDA listed —
Hydrogen Peroxide 3 mL/100mL 70000-0022-01 Cardinal 236 ml $0.006 — Availability likely —
Hydrogen Peroxide 2.65 mL/100mL 46122-0773-34 AmerisourceBergen 473 ml $0.018 — Availability likely —
Hydrogen Peroxide 2.65 mL/100mL 70677-1248-01 Strategic 473 ml $0.018 — Availability likely —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 00363-0268-16 Walgreens 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 00363-0871-43 Walgreen 473 ml — — Discontinued —
Humco Hydrogen Peroxide 30 mg/mLthis 00395-1113-16 Humco 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 00404-0001-01 Henry 3785 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 00869-0871-18 Vi-Jon, 118 ml — — Discontinued —
Hydrogen Peroxide 30 mg/mL 10202-0001-04 7-Eleven, 118 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 10565-0001-04 Hydrox 118 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 11673-0268-32 TARGET 946 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 11673-0871-43 Target 473 ml — — Discontinued —
Hydrogen Peroxide 8.57 g/100mL 12745-0202-01 Medical 59 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 21130-0871-43 Better 473 ml — — FDA listed —
Hydrogen Peroxide 2.65 mL/100mL 21130-0979-32 Safeway, 946 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 30142-0871-43 The 473 ml — — FDA listed —
3 Hydrogen Peroxide 30 mg/mL 30400-0250-01 Jell 177 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 33992-0871-04 Greenbrier 946 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 34645-0027-01 Jianerkang 1 pouch — — FDA listed —
Jianerkang One Fluid Ounce Hydrogen Peroxide 30 mg/mL 34645-0028-01 Jianerkang 1 pouch — — FDA listed —
Hydrogen Peroxide 2.65 mL/100mL 36800-0214-16 TOP 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 36800-0871-34 Topco 237 ml — — Discontinued —
Hydrogen Peroxide 30 mg/mL 37808-0871-43 H 473 ml — — FDA listed —
MediChoice of Hydrogen Peroxide 3 10 Volume 30 mg/mL 39892-0700-01 O&M 118 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 39892-0710-01 O&M 30 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 41163-0871-43 United 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 41250-0871-26 Meijer, 118 ml — — Discontinued —
Hydrogen Peroxide 30 mg/mL 42507-0817-43 Hy-Vee, 473 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 42681-6414-01 Whole 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 43128-0001-08 NDC, 237 ml — — FDA listed —
Everlit Care Products Antiseptic Mist 3 mL/100mL 43473-0112-01 Nantong 59 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 46994-0871-43 Save-A-Lot 473 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 49035-0268-16 EQUATE 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 49035-0871-43 Walmart 473 ml — — Discontinued —
Hydrogen Peroxide 3 Percent ReadyInCase 3 mL/100mL 49580-0268-03 P 946 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 50804-0156-16 Good 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 50804-0871-34 Perrigo 236 ml — — FDA listed —
DOP Hydrogen Peroxide 3% 3 g/100mL 51048-0040-08 Omega 237 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 51316-0268-16 CVS 473 ml — — FDA listed —
3% Hydrogen Peroxide 3 mL/100mL 52000-0433-16 Universal 473 ml — — FDA listed —
3 Hydrogen Peroxide 30 mg/mL 52000-0805-01 Universal 177 ml — — FDA listed —
Aplicare Hydrogen Peroxide 3 mL/100mL 52380-0013-01 Aplicare 30 ml — — Discontinued —
Aplicare 3 mL/100mL 52380-1013-03 Aplicare 30 ml — — FDA listed —
Hydrogen peroxide 3 mL/100mL 53329-0980-04 Medline 118 ml — — FDA listed —
Hydrogen Peroxide First Aid Antiseptic 3 mL/100mL 53329-0981-06 Medline 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 53942-0871-43 Demoulas 473 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 53943-0099-32 Discount 946 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 55301-0871-43 Your 473 ml — — FDA listed —
Hydrogen Peroxide 2.65 mL/100mL 55319-0567-16 Family 473 ml — — FDA listed —
3 Hydrogen Peroxide 30 mg/mL 55319-0672-01 Midwood 259 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 55910-0871-38 Old 295 ml — — Discontinued —
Hydrogen Peroxide 30 mg/mL 56062-0871-43 Publix 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 57243-0871-43 Salado 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 59779-0871-34 CVS 237 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 61504-0871-08 Amerifoods 3785 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 61734-0010-01 Delon 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 63941-0871-43 Valu 473 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 67091-0407-32 WinCo 946 ml — — FDA listed —
Hydrogen Peroxide .3 mL/mL 67326-0354-01 DEGASA 946 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 67751-0001-04 Navajo 118 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 67860-0871-43 Cariba 473 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 68196-0268-32 Sam's 946 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 68599-2305-09 McKesson 3800 ml — — FDA listed —
Hydrogen Peroxide 3 Percent 2.65 mL/100mL 69256-0268-16 Harris 473 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 70082-0111-16 DealMed 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 72036-0871-43 HARRIS 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 72288-0871-43 Amazon.com 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 72476-0942-34 Retail 237 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 82501-0871-01 GoBrands, 473 ml — — FDA listed —
Humco Hydrogen Peroxide 30 mg/mL 82645-0916-16 Pharma 473 ml — — FDA listed —
Hydrogen Peroxide 3% 3 mL/100mL 82749-0001-16 Epic 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 83324-0176-10 Chain 295 ml — — FDA listed —
HCS Hydrogen Peroxide 3% 3 mL/100mL 83506-0001-04 Concordance 118 ml — — FDA listed —
Everlit Care Products Antiseptic Mist 3 mL/100mL 83807-0033-01 EVERLIT 59 ml — — FDA listed —
3% Hydrogen Peroxide 3 mL/100mL 84809-0005-01 LJ 12 bottles — — FDA listed —
Booboo Bubbles 30 mg/mL 85324-0001-01 72 473 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 85828-0871-45 Grocery 946 ml — — FDA listed —
Florona Actilife Hydrogen Peroxide 3 % 3 mL/100mL 85891-0006-01 SPARROW 473 ml — — Discontinued —
Hydrogen Peroxide 3% 3 mL/100mL 87251-0002-16 4 473 ml — — FDA listed —
Hydrogen Peroxide 3 mL/100mL 87251-0004-16 4 236 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

🏛️
1998
On the market since
Mar 1998
📍
2026
Currently FDA-listed
28 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 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.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesPurified 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.

Manufacturer & labeler

LabelerHumco Holding Group, Inc.
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code00395
First marketedMar 1998
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 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses As an antiseptic to help prevent infection in minor cuts, scrapes, burns.

⏱️ Dosage and Administration 73 words ▾

Directions For antiseptic use: Clean the affected area, apply a small amount on the area 1 to 3 times daily. For oral rinse use: Adults and children 2 years and older mix with an equal amount of water and swish around and over the affected area then spit out. Use up to 4 times daily or as directed by a dentist or a doctor. Children under 2 years of age: consult a doctor.

⚠️ Warnings 40 words ▾

Warnings For external use except when used as an oral rinse. Do not use in the eyes. Do not apply over large areas of the body. Do not use longer than 1 week unless directed by a dentist or doctor.

🧪 Active Ingredient 5 words ▾

Active Ingredient Hydrogen Peroxide 3%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredient Purified water

🎯 Purpose 2 words ▾

Purpose Antiseptic

📄 Ask a Doctor Before Use If 16 words ▾

Ask a doctor before use if you have: deep or puncture wounds, animal bites, serious burns.

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop use consult a dentist or doctor if: condition persists or gets worse, sore mouth symptoms do not improve in 7 days, irritation, pain, redness or fever develop.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 15 words ▾

Other information Keep tightly closed and at controlled room temperature 15-30C (59-86F). Do not shake.

📄 Package Label / Principal Display Panel 12 words ▾

Principal package display Label 16 oz image description

New Label New 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 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 2 other package presentations of this same product, including 113 ml (00395-1113-94), 3800 ml (00395-1113-28). 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.
← 00395-1005-92 · Humco 00395-1207-16 · 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.