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Foster and Thrive Earwax Removal Kit Ear wax drops CARBAMIDE PEROXIDE Kit

by Mckesson Corp. Via Strategic Sourcing Services · 1 KIT in 1 KIT (70677-1153-1) * 1 BOTTLE in 1 BOX (70677-1154-1) / 15 mL in 1 BOTTLE
NDC 70677-1153-01
🏷️ FDA NDC (as labeled) 70677-1153-1 billing pads the package segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

⚠️
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

FDA NDC (as labeled) 70677-1153-1
Product NDC 70677-1153
11-digit billing NDC 70677115301
NCPDP billing unit ML — per mL (volume)
RxCUI 702050
UPC 0010939958211
Application # M014
SPL Set ID c9bd4c1f-b3b8-4bdc-b529-3a98b657e628
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-05-31
Dosage form KIT
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 FT EAR WAX REMOVAL 6.5% KIT
FDB brand name Ear Wax Removal
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 70677-1153-1 — a 5-4-1 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 package segment → 70677-1153-01. 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.

🏭 Manufacturer & labeler

LabelerMckesson Corp. Via Strategic Sourcing Services
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code70677
First marketedMay 2023
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.

🩺 Clinical

Label name FT EAR WAX REMOVAL 6.5% KIT Ingredient Carbamide Peroxide
🧪 What is this product?

This is an over-the-counter kit containing carbamide peroxide ear drops, marketed under FDA's OTC monograph rules for earwax removal products. Carbamide peroxide is commonly used in ear drop formulations because it releases oxygen when in contact with earwax, which helps soften and break down buildup in the ear canal. The kit typically includes the medicated drops and applicators or other tools designed to aid in the earwax removal process at home.

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.

🧪 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.

From the label’s inactive-ingredient sectionanhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

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.

💲 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 $0.163 —
Medicaid paysCMS SDUD · 12 mo $0.6413 —
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $0.168 $0.145
▲ Up 12% over the last 12 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ear Drops Major 6.5 g/100mL 00904-6627-35 Major 1 bottle $0.162 — Availability likely —
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 dropsthis 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/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.

⏳ Availability & generic status

🏛️
2023
On the market since
May 2023
📍
2026
Currently FDA-listed
3 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 70677-1153-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.1K
Units reimbursed last 4 qtrs
45K
Gross reimbursed last 4 qtrs
$28.8K
Avg / prescription
$9.23
Avg / unit
$0.6413
Latest quarter Q4 2025
614Rx
Medicaid pays / mL
$0.6413
gross reimbursed
vs
NADAC / mL
$0.1625
acquisition cost
=
Spread
+$0.4788
+295% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
46% FFS 54% MCO
Fee-for-service · 1,436 Rx Managed care · 1,688 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 4,305 units · 75.0 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 10,550 units · 53.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: 215 units · 6.7 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 3,600 units · 28.7 per 100k residents IL Indiana: no data reported IN Ohio: 7,575 units · 64.3 per 100k residents OH Pennsylvania: 1,020 units · 7.9 per 100k residents PA New Jersey: 1,215 units · 13.1 per 100k residents NJ Massachusetts: 195 units · 2.8 per 100k residents MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 33 units · 1.7 per 100k residents NE Missouri: no data reported MO Kentucky: 7,881 units · 174 per 100k residents KY West Virginia: no data reported WV Virginia: 2,415 units · 27.7 per 100k residents VA Maryland: 689 units · 11.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 2,610 units · 35.1 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 2,460 units · 45.8 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 180 units · 1.6 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 13 units · 0.0 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.0174
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 174 /100k
2 Minnesota 75.0 /100k
3 Ohio 64.3 /100k
4 New York 53.9 /100k
5 South Carolina 45.8 /100k
6 Arizona 35.1 /100k
7 Illinois 28.7 /100k
8 Virginia 27.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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 CARBAMIDE PEROXIDE — the ingredient across all brands.

Top reported reactions

Diarrhoea36
Fatigue26
Pain23
Fall20
Headache20
Nausea20
Dizziness19

Age at onset

Child3
Adolescent2
Adult33
Elderly32

Reporter sex

0 reports
Male · 49%
Female · 50%
Unknown · 0%

Serious outcomes

Death50
Disabling39
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 44 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
70677-1153-01 You're viewing this 1 KIT in 1 KIT (70677-1153-1) * 1 BOTTLE in 1 BOX (70677-1154-1) / 15 mL in 1 BOTTLE 2023-05-31 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) ✓ Available
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) ✓ Available
“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.
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 70677-1153-1, 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: 70677-1153-01, written without dashes as 70677115301. 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 70677-1153-01, the first segment (70677) is the labeler code FDA assigned to Mckesson Corp. Via Strategic Sourcing Services; the middle segment (1153) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Mckesson Corp. Via Strategic Sourcing Services. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Mckesson Corp. Via Strategic Sourcing Services 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.

📄 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
🎯 Indications and Usage 14 words ▾

Uses for occasional use as an aid to soften, loosen, and remove excessive earwax

⏱️ Dosage and Administration 97 words ▾

Directions FOR USE IN THE EAR ONLY Adults and children over 12 years of age: Tilt head sideways and places 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: consult a doctor

⚠️ Warnings 92 words ▾

Warnings For use in the ear only Ask a doctor before use if you have ear drainage or discharge 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 a 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. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 9 words ▾

Active ingredient Carbamide peroxide 6.5% Purpose Earwax removal aid

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

🎯 Purpose 4 words ▾

Purpose Earwax removal aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 70677-1152-01 · Strategic 70677-1154-01 · Mckesson →
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.