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Hydrogen Peroxide 30 mg/mL Solution, 3785 mL — NDC 61504-0871-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Hydrogen Peroxide 30 mg/mL Solution, 3785 mL — NDC 61504-871-08 (Billing 61504-0871-08) · Product 61504-871

by Amerifoods Trading Co · 3785 mL in 1 BOTTLE, PLASTIC (61504-871-08)

NDC 61504-871-08 (billing 61504-0871-08) is a package of 3,785 mL of Hydrogen Peroxide 30 mg/mL Solution from Amerifoods Trading Co, marketed since Feb 2017 and currently FDA-listed. It is the main listing for product NDC 61504-871, which comes in 3 package sizes.

NDC 61504-0871-08
🏷️ FDA NDC (as labeled) 61504-871-08 billing pads the product segment with a zero
This package
Contains3785 mL Pack sizes3 compare ↓
Main listing for product 61504-871 · Also comes in: 295 ml 61504-871-72 473 ml 61504-871-43
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

Past resolved recalls for this product (1)
Class II · Jun 28, 2022 · Terminated — Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol. (Vi-Jon, LLC) · FDA recall D-1244-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61504-871-08
Product NDC 61504-871
11-digit billing NDC 61504087108
RxCUI 91349
UNII BBX060AN9V
Application # M003
SPL Set ID 38b15693-7e5f-4c85-915e-9937ea018a83
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-09
Route TOPICAL
Dosage form SOLUTION
Substance HYDROGEN PEROXIDE
Quick answers for NDC 61504-871-08
  • RxCUI (RxNorm): 91349
  • 11-digit billing NDC: 61504087108
Why two NDCs? The FDA registers this code as 61504-871-08 — 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 → 61504-0871-08. 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

🧪 What is this product?

This is a topical solution containing hydrogen peroxide at a concentration of 30 mg/mL. Hydrogen peroxide is an over-the-counter monograph drug commonly used as an antimicrobial agent and cleansing aid for minor wounds, cuts, and abrasions when applied to the skin. The product functions as an oxidizing agent that may help remove debris and dead tissue from affected areas. This listing reflects an OTC monograph product, meaning it is marketed under FDA's established rules for this drug category rather than through an individual product application.

Supplement & herbal interactions

Some supplements/herbs that may interact with Hydrogen Peroxide — tap one for details:

Dimethylsulfoxide (dmso)Moderate Turpentine OilModerate AlchemillaMinor
🌿 Every supplement checked against Hydrogen Peroxide (3 interactions) — ranked by severity →
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: 295 ml 473 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
61504-0871-08 61504-871-08 You're viewing this Main listing 3785 mL in 1 BOTTLE, PLASTIC (61504-871-08) 2017-02-09 — Active
61504-0871-43 61504-871-43 473 mL in 1 BOTTLE, PLASTIC (61504-871-43) 2017-02-09 — Active
61504-0871-72 61504-871-72 295 mL in 1 BOTTLE, SPRAY (61504-871-72) 2017-02-09 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 61504-0871-08?
NDC 61504-0871-08 contains 3785 mL — 3785 ml in 1 bottle, plastic.
What is the difference between NDC 61504-0871-08 and NDC 61504-0871-72?
Both are Hydrogen Peroxide 30 mg/mL Solution — the drug itself is identical. NDC 61504-0871-08 is the 3785 mL package, while NDC 61504-0871-72 is the 295 ml package.
What NDC number is used to bill for this package of Hydrogen Peroxide 30 mg/mL Solution?
Bill NDC 61504-0871-08 — the 11-digit billing format is 61504087108. 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/mL 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/mLthis 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 —
Maokang 3 Hydrogen Peroxide 30 mg/mL 59050-0268-00 Changzhou 30 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 65055-0501-01 Laboratorios 224 ml — — Discontinued —
Oopsie 3 Hydrogen Peroxide 30 mg/mL 87251-0006-06 4 177 ml — — FDA listed —
Biopure 3 Hydrogen Peroxide 30 mg/mL 78691-0021-50 Quest 177 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 11344-0871-34 Nice-Pak 237 ml — — FDA listed —
American Red Cross 3 Hydrogen Peroxide 30 mg/mL 51628-4238-01 MY 177 ml — — FDA listed —
Hydrogen Peroxide 30 mg/mL 83986-0871-72 UpLift 295 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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

LabelerAmerifoods Trading Co
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code61504
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio2 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 🤒 Adverse Reactions 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Use first aid to help prevent the risk of infection in minor cuts, scrapes and burns aids in the removal of phlegm, mucus, or other secretions assoicated with occasional sore mouth

⏱️ Dosage and Administration 117 words ▾

Directions First aid antiseptic: clean the affected area apply a small amount of product on the affected area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first Oral debriding agent (oral rinse): adults and children 2 years of age and over: mix with an equal amount of water swish around in the mouth over the affected area for at least 1 minute and then spit out use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor children under 12 years of ago should be supervised in the use children under 2 years of age: consult a dentist or doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🤒 Adverse Reactions 17 words ▾

adverse reactions DISTRIBUTED BY: AMERIFOODS TRADING CO. P.O. BOX 512377, LOS ANGELES, CA 90051-0377 Pat. D675, 101

🧪 Active Ingredient 6 words ▾

Active ingredient Hydrogen peroxide (stablized) 3%

🧪 Inactive Ingredients 4 words ▾

Inactive ingredients purified water

🎯 Purpose 7 words ▾

Purpose First Aid Antiseptic Oral debriding agent

📄 Do Not Use 19 words ▾

Do not use in the eyes or apply over large areas of the the body longer than 1 week

📄 Ask a Doctor Before Use If 17 words ▾

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

📄 Stop Use and Ask a Doctor If 34 words ▾

Stop use and ask a doctor if the condition persists or gets worse 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 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 71 words ▾

principal display panel 61504-871-43 Iris ® Hydrogen Peroxide TOPICAL SOLUTION USP First Aid Antiseptic/Oral Debriding Agent For Treatment of Minor Cuts & Abrasions For use as a Gargle or Rinse Square bottle uses less plastic than a similarly sized round bottle Recyclable (if available in your area) DO NOT USE IF PRINTED SEAL UNDER CAP IS BROKEN OR MISSING NET 16 FL OZ (1 PT) 473 mL image description image description

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 FDA registers it as 61504-871-08, 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: 61504-0871-08, written without dashes as 61504087108. 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 61504-0871-08, the first segment (61504) is the labeler code FDA assigned to Amerifoods Trading Co; the middle segment (0871) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (08) 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 Amerifoods Trading Co. 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 295 ml (61504-0871-72), 473 ml (61504-0871-43). 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?
Amerifoods Trading Co 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.
← 61504-0810-08 · Amerifoods 61509-0100-18 · Cargus →
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.