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Ear Drops Major Carbamide Peroxide 6.5% 6.5 g/100mL Liquid — NDC 00904-6627-35 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ear Drops Major Carbamide Peroxide 6.5% 6.5 g/100mL Liquid — NDC 0904-6627-35 (Billing 00904-6627-35)

by Major Pharmaceuticals · 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE

This is a package of Ear Drops Major Carbamide Peroxide 6.5% 6.5 g/100mL Liquid from Major Pharmaceuticals, no longer marketed (first marketed Oct 2019), no longer in the FDA NDC Directory, this package's marketing ended Sep 2026; retail pharmacies pay about $0.1622 per mL (NADAC). It is this product's only package size.

NDC 00904-6627-35
🏷️ FDA NDC (as labeled) 0904-6627-35 billing pads the labeler segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0904-6627-35 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
0904 labeler · 6627 product · 35 package
Package marketed since
Oct 10, 2019
Package marketing ended
Sep 30, 2026
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 0904662735 7
Medicaid fills, this package
37,812 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Sep 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0904-6627-35
Product NDC 0904-6627
11-digit billing NDC 00904662735
NCPDP billing unit ML — per mL (volume)
RxCUI 702050
UNII 31PZ2VAU81
Application # M014
SPL Set ID ad8bce05-6be4-4f6c-9341-bce7c3aa05cf
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2019-10-10
Marketing end 2026-09-30
Route AURICULAR (OTIC)
Dosage form LIQUID
Substance CARBAMIDE PEROXIDE

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

GPI-14 87400030002010
GPI class Ear Drops
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 EAR DROPS 6.5%
FDB brand name Ear Drops
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 0904-6627-35 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00904-6627-35. 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

Label name EAR DROPS 6.5% Ingredient Carbamide Peroxide
🧪 What is this product?

Ear Drops Major is an over-the-counter liquid ear drop product containing carbamide peroxide. This product is marketed under FDA's OTC monograph rules for ear-care products. Carbamide peroxide is typically used in ear drops to help soften and break up earwax buildup in the ear canal, making it easier to remove. The solution is applied directly into the ear as drops.

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 $0.162 $2.43 / 15 ml
Medicaid paysCMS SDUD · 12 mo $0.5635 $8.45 / 15 ml
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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.178 $0.109
▲ Up 40% over the last 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00904-6627-35 You're viewing this Main listing 1 BOTTLE in 1 CARTON / 15 mL in 1 BOTTLE 2019-10-10 Sep 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ear Drops Major 6.5 g/100mLthis 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/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

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 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.

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

LabelerMajor Pharmaceuticals
FDA applicationM014 (OTC MONOGRAPH DRUG)
Labeler code00904
First marketedOct 2019
Product typeHuman Otc Drug
Portfolio630 products on file

More NDCs from Major Pharmaceuticals labeler code 00904

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 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

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

⏱️ Dosage and Administration 104 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 118 words ▾

Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away

🧪 Active Ingredient 3 words ▾

Carbamide Peroxide 6.5%

🧪 Inactive Ingredients 12 words ▾

Citric Acid, Flavor, Glycerin, Propylene Glycol, Sodium Lauroyl Sarcosinate, Sodium Stannate, Water

🎯 Purpose 3 words ▾

Earwax Removal Aid

📄 Keep Out of Reach of Children 13 words ▾

If swallowed, get medical help or contact a Poison Control Center right away.

📄 Package Label / Principal Display Panel 2 words ▾

major2.jpg major

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 this package alone, 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 – Q1 2026 · 5 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
37.8K
Units reimbursed last 4 qtrs
569.5K
Gross reimbursed last 4 qtrs
$320.9K
Avg / prescription
$8.49
Avg / unit
$0.5635
Latest quarter Q1 2026
1.6KRx
Medicaid pays / mL
$0.5635
gross reimbursed
vs
NADAC / mL
$0.1622
acquisition cost
=
Spread
+$0.4013
+247% 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 ⓘ
52% FFS 48% MCO
Fee-for-service · 19,488 Rx Managed care · 18,324 Rx
State Medicaid map
Alaska: no data reported AK Maine: 4,365 units · 313 per 100k residents ME Washington: 19,787 units · 253 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 18,480 units · 322 per 100k residents MN Wisconsin: no data reported WI Michigan: 1,395 units · 13.9 per 100k residents MI New York: 189,856 units · 970 per 100k residents NY Vermont: 855 units · 132 per 100k residents VT New Hampshire: 435 units · 31.0 per 100k residents NH Oregon: 2,280 units · 53.9 per 100k residents OR Nevada: 6,240 units · 195 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 32,270 units · 257 per 100k residents IL Indiana: 3,345 units · 48.7 per 100k residents IN Ohio: 28,425 units · 241 per 100k residents OH Pennsylvania: 84,377 units · 651 per 100k residents PA New Jersey: 50,150 units · 540 per 100k residents NJ Massachusetts: no data reported MA California: 1,601 units · 4.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 7,575 units · 383 per 100k residents NE Missouri: no data reported MO Kentucky: 25,710 units · 568 per 100k residents KY West Virginia: no data reported WV Virginia: 9,735 units · 112 per 100k residents VA Maryland: 5,570 units · 90.1 per 100k residents MD Connecticut: no data reported CT Rhode Island: 7,365 units · 673 per 100k residents RI Arizona: 5,880 units · 79.1 per 100k residents AZ New Mexico: 840 units · 39.7 per 100k residents NM Kansas: 4,875 units · 166 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: 5,613 units · 104 per 100k residents SC Delaware: 2,445 units · 237 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 8,250 units · 74.8 per 100k residents GA D.C.: 2,370 units · 349 per 100k residents DC Hawaii: 360 units · 25.1 per 100k residents HI Texas: 39,062 units · 128 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.1970
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 New York 970 /100k
2 Rhode Island 673 /100k
3 Pennsylvania 651 /100k
4 Kentucky 568 /100k
5 New Jersey 540 /100k
6 Nebraska 383 /100k
7 D.C. 349 /100k
8 Minnesota 322 /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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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) ✓ 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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Major Pharmaceuticals 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.
← 00904-6624-61 · Major 00904-6634-44 · Major →
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.