Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
GoodSense Ear Wax Removal Kit Carbamide Peroxide 6.5 g/100mL Liquid — NDC 50804-117-11 (Billing 50804-0117-11)
by Geiss, Destin & Dunn, Inc · 1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE
This is a package of GoodSense Ear Wax Removal Kit Carbamide Peroxide 6.5 g/100mL Liquid from Geiss, Destin & Dunn, Inc, marketed since May 2025 and currently FDA-listed.
NDC 50804-0117-11
🏷️ FDA NDC (as labeled)
50804-117-11
billing pads the product segment with a zero
This package
Contains15 mL in 1 bottle
Pack sizes2 compare ↓
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 50804-117-11 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 50804 labeler · 117 product · 11 package
- Package marketed since
- May 1, 2025
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0846036009859, 0846036001747
- 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)
50804-117-11
Product NDC
50804-117
11-digit billing NDC
50804011711
NCPDP billing unit
ML — per mL (volume)
RxCUI
702050
UNII
31PZ2VAU81
UPC
0846036009859, 0846036001747
Application #
M014
SPL Set ID
31ea324f-a9a1-7865-e063-6294a90a92e8
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2025-05-01
Route
TOPICAL
Dosage form
LIQUID
Substance
CARBAMIDE PEROXIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
87400030002010
GCN Seq No
008120
GCN
34401
HICL code
004272
Ingredient (HICL)
Carbamide Peroxide
HIC1 code
Q
Therapeutic class — broad (HIC1)
Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code
Q8
Therapeutic class — intermediate (HIC2)
Otic Preparations
HIC3 code
Q8R
Therapeutic class — specific (HIC3)
Ear Preparations,Ear Wax Removers
AHFS code
52:04.24.00
AHFS class
Astringents (52:04)
FDB label name
GS EAR WAX REMOVAL 6.5% DROP
FDB brand name
Ear Wax Removal
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 008120
- GCN: 34401
- GPI-14 (Medi-Span): 87400030002010
- HICL (First Databank): 004272
- AHFS class code: 52:04.24.00
- RxCUI (RxNorm): 702050
Why two NDCs?
The FDA registers this code as 50804-117-11 — 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 → 50804-0117-11. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Label name GS EAR WAX REMOVAL 6.5% DROP Ingredient Carbamide Peroxide
🧪 What is this product?
This is an over-the-counter ear wax removal liquid containing carbamide peroxide at a strength of 6.5 grams per 100 milliliters. Applied topically to the ear canal, carbamide peroxide is commonly used to help soften and break down earwax buildup. It works by releasing oxygen when it contacts earwax, which helps loosen the material so it may drain or be removed more easily. This product is marketed as an OTC monograph drug, meaning it follows established FDA guidelines for over-the-counter ear wax removal products.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Carbamide Peroxide?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per mL | Per 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:
15 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50804-0117-01 50804-117-01 Main listing | 1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE | 2025-05-01 | — | Active |
| 50804-0117-11 You're viewing this | 1 BOTTLE in 1 BOX / 15 mL in 1 BOTTLE | 2025-05-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 1 bottle in 1 box / 15 ml in 1 bottle.
What NDC number is used to bill for this package of GoodSense Ear Wax Removal Kit Carbamide Peroxide 6.5 g/100mL 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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/100mLthis 50804-0117-11 | 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/100mL 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
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 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
-
UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
-
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
-
UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
-
UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
-
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesCitric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerGeiss, Destin & Dunn, Inc
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code50804
First marketedMay 2025
Product typeHuman Otc Drug
Portfolio9 products on file
More NDCs from Geiss, Destin & Dunn, Inc labeler code 50804
- Antiseptic Mouth Rinse EUCALYPTOL .92 mg/mL; .42 mg/mL; .6 mg/mL; .64 mg/mL Mouthwash NDC 50804-072-69
- GoodSense SPF 50 Sunscreen Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10% 5 g/100mL; 3 g/100mL; 10 g/100mL; 15 g/100mL Lotion NDC 50804-083-08
- Allergy Relief Diphenhydramine HCl 25 mg Capsule NDC 50804-091-08
- Good Sense Artificial Tears polyvinyl alcohol, povidone .5 g/100mL; .6 g/100mL Solution NDC 50804-110-01
- GoodSense Regular Strength Antacid Calcium carbonate 500 mg Tablet, Chewable NDC 50804-112-17
- Goodsense Regular Strength Antacid Peppermint Calcium carbonate 500 mg Tablet, Chewable NDC 50804-113-17
- GoodSense Eye Drops Irritation Relief tetrahydrozoline HCl, zinc sulfate .05 g/100mL; .25 g/100mL Solution NDC 50804-121-01
- GS Stomach Relief Bismuth subsalicylate 525 mg 525 mg/30mL Liquid NDC 50804-122-04
- Sinus and Headache ACETAMINOPHEN and PHENYLEPHRINE HYDROCHLORIDE 325 mg; 5 mg Tablet, Coated NDC 50804-123-05
- Good Sense Hot and Cold Medicated Patch MENTHOL 5 g/100g Patch NDC 50804-124-13
- Goodsense Extra Strength Cold and Hot Medicated Menthol 50 mg Patch NDC 50804-126-05
- Goodsense Extra Strength Antacid Assorted Fruit Calcium carbonate 750 mg Tablet, Chewable NDC 50804-127-22
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
For occasional use as an aid to soften, loosen, and remove excessive earwax.
⏱️ Dosage and Administration ▾
FOR USE IN 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 ▾
Do not use if you have ear drainage or discharge, ear pain, irritation or rash in the ear or are dizzy; consult a doctor if you have an injury or perforation (hole) in the ear drum or after ear surgery, unless directed by a doctor for more than 4 days; if excessive earwax remains after use of this product, consult a doctor When using this product avoid contact with yes. If accidental contact with yes occurs, flush eyes with water and consult a doctor.
🧪 Active Ingredient ▾
Carbamide Peroxide 6.5%
🧪 Inactive Ingredients ▾
Citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, tartaric acid
🎯 Purpose ▾
Earwax removal aid
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
carton Carton
No label section mentions that — try another word, or open the full label on DailyMed below.
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 GoodSense Ear Wax Removal Kit (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 62%
Female · 38%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 Geiss, Destin & Dunn, 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 1 bottle (50804-0117-01). 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?
Geiss, Destin & Dunn, 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.
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.