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DoloEar Carbamide Peroxide 6.5 g/100mL Liquid — NDC 55758-0506-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

DoloEar Carbamide Peroxide 6.5 g/100mL Liquid — NDC 55758-506-01 (Billing 55758-0506-01)

by Pharmadel LLC · 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER

This is a package of DoloEar Carbamide Peroxide 6.5 g/100mL Liquid from Pharmadel LLC, marketed since May 2025 and currently FDA-listed. It is this product's only package size.

NDC 55758-0506-01
🏷️ FDA NDC (as labeled) 55758-506-01 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

NDC database record

One package, one record: these facts belong to NDC 55758-506-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55758 labeler · 506 product · 01 package
Package marketed since
May 15, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5575850601 5
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Carbamide Peroxide (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0680-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0679-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0685-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0683-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0688-2026
Class II · Jun 25, 2026 — SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). (Bell Pharmaceuticals, Inc) · FDA recall D-0687-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55758-506-01
Product NDC 55758-506
11-digit billing NDC 55758050601
RxCUI 702050
UNII 31PZ2VAU81
Application # M014
SPL Set ID 352df636-0469-c33e-e063-6294a90a2224
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-05-15
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance CARBAMIDE PEROXIDE
Quick answers
  • RxCUI (RxNorm): 702050
Why two NDCs? The FDA registers this code as 55758-506-01 — 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 → 55758-0506-01. 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

🧪 What is this product?

DoloEar Carbamide Peroxide 6.5 g/100mL is a liquid eardrops product marketed as an over-the-counter monograph drug. Carbamide peroxide is an oxidizing agent commonly used in otic products to help soften and remove earwax buildup in the ear canal. This product is applied directly into the ear and is intended for typical at-home use by adults and children as directed on the package labeling.

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
55758-0506-01 You're viewing this Main listing 1 BOTTLE, DROPPER in 1 CARTON / 15 mL in 1 BOTTLE, DROPPER 2025-05-15 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ear Drops Major 6.5 g/100mL 00904-6627-35 Major 1 bottle $0.162 — Discontinued —
Major Earwax Removal Drops Earwax Removal Aid 65 mg/mL 00904-7478-35 Major 1 bottle $0.162 — Availability likely —
Ear Wax Removal Drops 65 mg/mL 11527-0143-51 Sheffield 1 bottle $0.162 — Availability likely —
Good Neighbor Pharmacy Earwax Removal 46122-0556-05 Amerisource 1 kit $0.162 — Availability likely —
Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 46122-0557-05 Amerisource 1 bottle $0.162 — Availability likely —
Leader Earwax Removal Drops Earwax Removal Aid 65 mg/mL 70000-0688-01 Cardinal 1 bottle $0.162 — Availability likely —
Foster and Thrive Earwax Removal Kit Ear wax drops 70677-1153-01 Mckesson 1 kit $0.162 — Availability likely —
Foster and Thrive Earwax Removal Drops 65 mg/mL 70677-1154-01 Mckesson 1 bottle $0.162 — Availability likely —
Deluxe Ear Wash system 00363-2231-10 Walgreens 1 kit — — FDA listed —
Ear Wax Removal Drops Up and Up 65 mg/mL 11673-0761-05 Target 1 bottle — — FDA listed —
Ear Wax Removal Aid Drops .065 mg/mL 11673-0793-15 Target 1 bottle — — FDA listed —
EarWax Removal Kit Rite Aid 11822-1222-07 Rite 1 kit — — FDA listed —
EAR WAX RMVL Rite Aid 6.5 g/100mL 11822-1224-01 Rite 15 ml — — FDA listed —
Rite Aid Earwax Removal Drops 6.5 g/100mL 11822-6117-00 Rite 1 bottle — — FDA listed —
ClearCanal Ear Wax Softerner Drops 65 mg/mL 13709-0230-01 NeilMed 1 bottle — — FDA listed —
SuavEar Earwax Removal Aid 65 mg/mL 13709-0312-01 NEILMED 1 bottle — — FDA listed —
Wax Out Plus 65 mg/mL 13709-0313-01 NEILMED 1 bottle — — FDA listed —
NeilMed Clear Canal Earwax Removal kit 65 mg/mL 13709-0314-01 NEILMED 1 bottle — — FDA listed —
Otix Ear wax Removal Drops 65 mg/mL 15579-0838-34 Bell 1 bottle — — FDA listed —
Otix Ear wax Removal System Ear wax and Bulb 15579-0839-33 Bell 1 kit — — FDA listed —
Ear Wax Removal Aid Drops 65 mg/mL 21130-0793-15 BETTER 1 bottle — — FDA listed —
TopCare Earwax Removal Kit 65 mg/mL 36800-0835-33 TOPCO 1 bottle — — FDA listed —
Equaline Earwax Removal Drops 65 mg/mL 41163-0835-34 United 1 bottle — — FDA listed —
Meijer Earwax Removal Drops 65 mg/mL 41250-0282-34 Meijer 1 bottle — — FDA listed —
Meijer Earwax Removal Kit 65 mg/mL 41250-0835-33 Meijer 1 bottle — — FDA listed —
Ear Wax Removal Drops Equate 65 mg/mL 49035-0862-01 WALMART 1 bottle — — FDA listed —
Debrox 65 mg/mL 50090-4201-00 A-S 1 bottle — — FDA listed —
Ear Drops Major 6.5 g/100mL 50090-5273-00 A-S 1 bottle — — FDA listed —
Clearcanal Ear Wax Softerner Drops 65 mg/mL 50090-7426-00 A-S 1 bottle — — FDA listed —
Foster And Thrive Earwax Removal Drops 65 mg/mL 50090-7510-00 A-S 1 bottle — — FDA listed —
GoodSense Ear Wax Removal Kit 6.5 g/100mL 50804-0117-01 Geiss, 1 bottle — — FDA listed —
CVS Health Earwax Removal Drops Earwax Removal Aid 65 mg/mL 51316-0822-00 CVS 1 bottle — — FDA listed —
CVS Health Earwax Removal Kit 51316-0823-00 CVS 1 kit — — FDA listed —
ERO Ear Wax Removal Kit 6.5 g/100mL 52412-0175-01 Randob 1 bottle — — FDA listed —
DISCOUNT drug mart FOOD FAIR earwax removal kit 65 mg/mL 53943-0835-33 Discount 1 bottle — — FDA listed —
Discount Drug Mart Earwax Removal Drops 65 mg/mL 53943-0838-34 Discount 1 bottle — — FDA listed —
Family Wellness Earwax Removal Earwax and Bulb 55319-0835-01 Family 1 kit — — FDA listed —
DoloEar 6.5 g/100mLthis 55758-0506-01 Pharmadel 1 bottle — — FDA listed —
Ear Wax Removal Drops 65 mg/mL 57896-0339-05 GeriCare 1 bottle — — FDA listed —
Audiologists Choice Earwax Removal System 65 mg/mL 59256-0001-02 Oaktree 1 bottle — — FDA listed —
Audiologists Choice Earwax Removal Aid Drops 65 mg/mL 59256-0836-34 Oaktree 1 bottle — — FDA listed —
Debrox 65 mg/mL 63029-0321-01 Medtech 1 bottle — — FDA listed —
Quality Choice Earwax Removal Kit 65 mg/mL 63868-0026-15 Chain 1 bottle — — FDA listed —
Quality Choice Earwax Removal Drops 65 mg/mL 63868-0027-16 Chain 1 bottle — — FDA listed —
Best Choice Earwax Removal Kit 65 mg/mL 63941-0835-33 Valu 1 bottle — — FDA listed —
Best Choice Earwax Removal Drops 65 mg/mL 63941-0836-34 Valu 1 bottle — — FDA listed —
Family Care Earwax Removal .065 mg/mL 65923-0639-15 United 1 bottle — — FDA listed —
Wax Away Earwax Removal Aid 65 mg/mL 66354-0005-81 McKeon 1 bottle — — FDA listed —
Wax Away Earwax Removal System 65 mg/mL 66354-0006-80 McKeon 1 bottle — — FDA listed —
ProRinse Earwax Removal System 65 mg/mL 66354-0007-82 McKeon 1 bottle — — FDA listed —
Ear Wax Removal Aid Drops .065 mg/mL 68016-0793-15 PHARMACY 1 bottle — — FDA listed —
ENT Essentials Ear Wax Remvoer .065 g/g 68093-4503-01 Wisconsin 1 bottle — — FDA listed —
Clinere Ear Wax Remover .065 g/mL 68229-0102-02 Quest 1 bottle — — FDA listed —
Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 68788-8586-01 Preferred 1 bottle — — FDA listed —
GoodSense Ear Wax Removal Kit 6.5 g/100mL 68788-8615-01 Preferred 1 bottle — — FDA listed —
Carbamide peroxide 6.5% 65 mg/mL 69168-0488-68 Allegiant 1 bottle — — FDA listed —
Harris Teeter Earwax Removal Drops 6.5 g/100mL 69256-0117-01 Harris 1 bottle — — FDA listed —
Tech Care Earwax Removal Drops 65 mg/mL 69428-0002-00 Warner 1 bottle — — FDA listed —
Tech Care Earwax Removal Kit 69428-0003-00 Warner 1 kit — — FDA listed —
ear drops .065 mg/mL 69452-0377-95 Bionpharma 2 bottles — — FDA listed —
Healthy Ears 6.5 mg/mL 69469-0650-05 Vitamex 14.7 ml — — FDA listed —
Ear Drops .065 mg/mL 69842-0097-45 CVS 1 bottle — — FDA listed —
Ear Wash Refill CVS 69842-0877-14 CVS 1 kit — — FDA listed —
Leader Earwax Removal Kit Earwax Removal Aid and Bulb 70000-0689-01 Cardinal 1 kit — — FDA listed —
Good Neighbor Pharmacy Earwax Removal Drops 65 mg/mL 71205-0260-15 Proficient 1 bottle — — FDA listed —
CareOne Earwax Removal Drops 65 mg/mL 72476-0838-34 Retail 1 bottle — — FDA listed —
WaxRx Ear Wax Removal Aid Drops 6.5 g/100mL 72724-0001-15 DOCTOR 15 ml — — FDA listed —
DG Health Earwax Removal kit 65 mg/mL 75712-0301-14 DOLLAR 1 bottle — — FDA listed —
TopCare Earwax Removal Drops 65 mg/mL 76162-0836-34 Topco 1 bottle — — FDA listed —
Ear Wash Refill Equate 79903-0403-50 Walmart 1 kit — — FDA listed —
Wax B Gone Ear Wax Removal Drops 65 mg/mL 82498-0149-15 SIGMAR, 1 bottle — — FDA listed —
Freskaro Earwax Removal Aid 6.5 g/100mL 82645-0097-45 Pharma 1 bottle — — FDA listed —
Quality Choice Earwax Removal Kit Earwax Removal Aid and Bulb 83324-0282-05 Chain 1 kit — — FDA listed —
Quality Choice Earwax Removal Drops Earwax Removal Aid 65 mg/mL 83324-0283-05 Chain 1 bottle — — FDA listed —
Lucid Hearing Earwax Removal Kit and Bulb 84320-0001-00 Hearing 1 kit — — 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

🏛️
2025
On the market since
May 2025
📍
2026
Currently FDA-listed
1 year 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.

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

LabelerPharmadel LLC
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code55758
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio67 products on file

More NDCs from Pharmadel LLC labeler code 55758

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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses For occasional use as an aid to loosen and remove excessive earwax.

⏱️ Dosage and Administration 99 words ▾

Directions FOR USE IN THE EAR ONLY adults and children over 12 years of age: tilt head sideways and place 5 to 10 drops into ear. Tip of applicator should not enter ear canal. Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear.

Use twice daily for up to 4 days if needed, or as directed by a doctor. Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe. children under 12 years of age: consult a doctor

⚠️ Warnings 74 words ▾

Warnings Ask a doctor before use if you have ear drainage or discharge ear pain irritation or rash in the ear dizziness an injury or perforation (hole) of the ear drum recently had ear surgery When using this product avoid contact with the eyes. Stop use and ask your doctor if you need to use for more than 4 days excessive earwax remains after use of this product Keep out of reach of children.

🧪 Active Ingredient 14 words ▾

Active Ingredient and Purpose . Active ingredient Purpose Carbamide peroxide 6.5%............... Earwax removal aid

🧪 Inactive Ingredients 4 words ▾

Inactive ingredients glycerin, water

🎯 Purpose 9 words ▾

Active ingredient Purpose Carbamide peroxide 6.5%............... Earwax removal aid

📄 When Using This Product 9 words ▾

When using this product avoid contact with the eyes.

📄 Stop Use and Ask a Doctor If 24 words ▾

Stop use and ask your doctor if you need to use for more than 4 days excessive earwax remains after use of this product

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 21 words ▾

Other information Store in a cool dry place do not use if clear seal over dropper is torn, broken, or missing

📄 Questions or Comments 13 words ▾

Questions or comments? +1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel PDP DOLOEAR

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 DoloEar (this brand).

Top reported reactions

Diarrhoea14
Chronic Kidney Disease9
Pneumonia9
Fatigue8
Pyrexia8
Abdominal Pain7
Blood Creatinine Increased7

Age at onset

Adolescent1
Adult11
Elderly14

Reporter sex

163 reports
Male · 62%
Female · 38%
Unknown · 1%

Serious outcomes

Hospitalization75
Life-threatening6
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 16 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 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 Pharmadel LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmadel 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.
← 55758-0505-01 · Pharmadel 55758-0507-01 · Pharmadel →
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.