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Foster and Thrive Medicated Corn Removers 40% w/w Salicylic Acid Corn Remover 40 mg/100mg Plaster, 100 mg — NDC 70677-1237-1 (Billing 70677-1237-01)

by Strategic Sourcing Services LLC · 100 mg in 1 BOX

This is a package of 100 mg of Foster and Thrive Medicated Corn Removers 40% w/w Salicylic Acid Corn Remover 40 mg/100mg Plaster from Strategic Sourcing Services LLC, marketed since May 2024 and currently FDA-listed; retail pharmacies pay about $0.1025 per unit (NADAC). It is this product's only package size.

NDC 70677-1237-01
🏷️ FDA NDC (as labeled) 70677-1237-1 billing pads the package 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 →

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70677-1237-1
Product NDC 70677-1237
11-digit billing NDC 70677123701
NCPDP billing unit EA — each (per item)
RxCUI 240559
UNII O414PZ4LPZ
Application # M030
SPL Set ID 1a51a539-e9b5-9dab-e063-6294a90a6cd2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-05-07
Route TOPICAL
Dosage form PLASTER
Substance SALICYLIC ACID

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

GPI-14 90750030004340
GCN Seq No 016337
GCN 47162
HICL code 002465
Ingredient (HICL) Salicylic Acid
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L5
Therapeutic class — intermediate (HIC2) Keratolytics/Keratoplastics
HIC3 code L5A
Therapeutic class — specific (HIC3) Keratolytics
AHFS code 84:28.00.00
AHFS class Keratolytic Agents
FDB label name FT CORN REMOVER 40% DISC
FDB brand name Corn Remover
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 016337
  • GCN: 47162
  • GPI-14 (Medi-Span): 90750030004340
  • HICL (First Databank): 002465
  • AHFS class code: 84:28.00.00
  • RxCUI (RxNorm): 240559
Why two NDCs? The FDA registers this code as 70677-1237-1 — 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 → 70677-1237-01. 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.

RxNorm drug class

This medicine belongs to the Salicylic acid and derivatives class.

Drug family (ATC) Salicylic acid and derivatives, Other antifungals for topical use, Antiinflammatory agents, non-steroids
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name FT CORN REMOVER 40% DISC Ingredient Salicylic Acid
📗 Our plain-language guide HelloPharmacist
  • It is used in a facial routine for acne-prone and oil-prone skin. The routine includes a cleanser, serum, toner and emulsion. Salicylic acid helps loosen and shed dead skin cells.
  • Use the cleanser morning and evening, and the serum in the morning after cleansing. Use the toner in the evening on dry skin, and the emulsion at night after cleansing. Avoid your...
  • Mild stinging, burning, itching, dryness and extra peeling can happen. If dryness or peeling bothers you, try using the serum or toner every other day. If it gets excessive, stop a...
  • It is best not to. Using another topical acne medication at the same time makes irritation and dryness more likely. If you get irritated, use only one at a time.
📖 Read our full Salicylic Acid Topical guide →
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 eaPer package
Retail pharmacies payNADAC · weekly $0.103 $0.10 / 1 box
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.
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.108 $0.098
Flat over the last 10 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
70677-1237-01 You're viewing this Main listing 100 mg in 1 BOX 2024-05-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Salicylic Acid 40 mg/41 46122-0524-13 AmerisourceBergen 4 patches $0.102 — Availability likely —
Salicylic Acid 40 mg/91 46122-0526-23 AmerisourceBergen 9 patches $0.102 — Availability likely —
Salicylic Acid 400 mg/g 70000-0330-01 LEADER/ 9 patches $0.102 — Availability likely —
Salicylic Acid 400 mg/g 70000-0333-01 LEADER/ 4 patches $0.102 — Availability likely —
Medicated Wart Remover Strips 400 mg/g 70000-0732-01 CARDINAL 18 patches $0.102 — Availability likely —
Foster and Thrive Medicated Corn Removers 40 mg/100mgthis 70677-1237-01 Strategic 100 mg $0.102 — Availability likely —
Salicylic Acid 40 mg/181 00363-0203-18 Walgreen 18 patches — — FDA listed —
Salicylic Acid 40 mg/121 00363-1747-01 Walgreens 18 patches — — FDA listed —
Walgreens maximum strength ONE-STEP Corn Remover 1.35 mg 00363-1972-06 Walgreen 6 strips — — Discontinued —
Walgreens Medicated Corn Removers .54 mg 00363-2025-09 Walgreen 9 patches — — Discontinued —
Walgreens Corn Remover 4.42 mg 00363-3063-02 WALGREENS 6 strips — — FDA listed —
Salicylic Acid 40 mg/91 00363-5523-09 Walgreens 9 patches — — FDA listed —
Walgreens EXTRA THICK Callus Removers .23 g 00363-6045-04 Walgreen 4 patches — — Discontinued —
Salicylic Acid 40 mg/41 00363-7730-04 Walgreen 4 patches — — FDA listed —
Salicylic Acid 40 mg/91 00363-9757-09 Walgreen 9 patches — — FDA listed —
Salicylic Acid 40 mg/181 11822-0123-08 Rite 18 patches — — Discontinued —
Salicylic acid 40 mg/41 11822-0125-04 Rite 4 patches — — Discontinued —
Salicylic Acid 40 mg/91 11822-0132-09 Rite 9 patches — — Discontinued —
Salicylic acid .4 g/181 11822-0134-01 Rite 18 plasters — — FDA listed —
Wart Remover .4 g 28691-0400-02 Pharmaplast 10 plasters — — FDA listed —
Cure-Aid Corn Plasters 40 mg 28691-4000-01 Pharmaplast 12 patches — — FDA listed —
Salicylic Acid 40 mg/181 30142-0127-18 Kroger 18 patches — — FDA listed —
Salicylic Acid 40 mg/91 30142-0128-09 Kroger 9 patches — — FDA listed —
Salicylic Acid 40 mg/41 36800-0019-04 Topco 4 patches — — FDA listed —
Salicylic Acid 40 mg/91 36800-0021-09 Topco 9 patches — — FDA listed —
Salicylic acid 40 mg/41 36800-0373-04 Topco 4 patches — — FDA listed —
Salicylic acid .4 g/181 36800-0377-14 Topco 18 plasters — — FDA listed —
Salicylic Acid 40 mg/241 36800-0378-24 Topco 24 patches — — FDA listed —
Salicylic acid 40 mg/41 37808-0522-04 HEB 4 patches — — FDA listed —
Salicylic Acid 40 mg/91 37808-0525-09 HEB 9 patches — — FDA listed —
Salicylic acid 40 mg/41 41163-0135-04 United 4 patches — — FDA listed —
Salicylic Acid 40 mg/91 41163-0136-09 United 9 patches — — FDA listed —
Salicylic Acid .4 g/g 41163-0137-09 United 9 pouches — — FDA listed —
Salicylic Acid 40 mg/241 41250-0243-24 Meijer 24 patches — — FDA listed —
Salicylic Acid 40 mg/91 41520-0558-09 Foodhold 9 patches — — FDA listed —
Salicylic Acid 40 mg/41 41520-0570-04 Foodhold 4 patches — — FDA listed —
Salicylic Acid 400 mg/g 42507-0999-01 HY-VEE, 9 patches — — FDA listed —
Extra Thick Callus Removers 40 mg/100mg 49035-0019-04 Wal-Mart 160 mg — — FDA listed —
Salicylic acid 40 mg/91 49035-0155-09 Wal-Mart 9 patches — — FDA listed —
Salicylic Acid 40 mg/121 51316-0491-25 CVS 6 patches — — FDA listed —
Wart Remover 400 mg/g 51316-0757-18 CVS 18 patches — — FDA listed —
Salicylic Acid Wart Remover 40 mg 51511-0596-01 ASO 14 strips — — FDA listed —
Salicylic Acid 40% / Corn Remover .4 g/g 51511-0599-12 ASO 16800 patches — — FDA listed —
MediPlast 40 g/100g 53329-0410-09 Medline 1 applicator — — FDA listed —
Salicylic Acid 40 mg/41 53943-0004-04 Discount 4 patches — — FDA listed —
Medicated Corn Removers 400 mg/g 55319-0476-09 Family 4 pouches — — FDA listed —
Medicated Corn Remover 40 mg/91 55910-0857-01 Dolgencorp, 9 patches — — FDA listed —
Salicylic Acid 40 mg/91 56104-0011-09 Premier 9 patches — — FDA listed —
Salicylic acid 40 mg/41 56104-0013-04 Premier 4 patches — — FDA listed —
Salicylic Acid 40 mg/181 56104-0017-18 Premier 18 patches — — FDA listed —
Salicylic Acid 40 mg/121 56104-0258-01 Premier 6 patches — — FDA listed —
Salicylic Acid 400 mg/g 56104-0905-01 Premier 9 patches — — FDA listed —
Salicylic Acid 400 mg/g 56104-0910-01 Premier 18 patches — — FDA listed —
Premier Solutions Wart Removers 400 mg/g 56104-0911-01 Premier 18 patches — — FDA listed —
Medicated Callus Removers 400 mg/g 56104-0913-01 Premier 4 patches — — FDA listed —
Gel Corn Remover 400 mg/g 59640-0802-01 HEB 6 patches — — FDA listed —
Salicylic Acid 40 mg/91 59779-0115-09 CVS 9 patches — — FDA listed —
Salicylic acid 40 mg/41 59779-0116-04 CVS 4 patches — — FDA listed —
Salicylic Acid 40 mg/181 59779-0136-18 CVS 18 patches — — FDA listed —
Plantar Wart Remover 400 mg/g 59779-0138-24 CVS 24 patches — — FDA listed —
Salicylic Acid 40 mg/41 59779-0569-10 CVS 4 patches — — FDA listed —
Salicylic Acid 40 mg/91 59779-0570-18 CVS 9 patches — — FDA listed —
Compound W One Step Plantar Foot Pads .4 g 63029-0593-20 Medtech 20 plasters — — FDA listed —
Compound W One Step Pads .4 g 63029-0594-14 Medtech 14 plasters — — FDA listed —
Compound W Maximum Strength One Step Invisible 4 mg 63029-0596-14 Medtech 14 plasters — — FDA listed —
Compound W for Kids One Step Strips .4 g 63029-0598-10 Medtech 10 plasters — — FDA listed —
Compound W Corn Remover .4 g/g 63029-0599-08 Medtech 8 patches — — FDA listed —
Compound W One Step Medicated Corn Remover .4 g 63029-0621-08 Medtech 8 plasters — — FDA listed —
Salicylic Acid 40 mg/91 63868-0040-09 Chain 9 patches — — FDA listed —
Salicylic Acid 40 mg/41 63868-0041-04 Chain 4 patches — — FDA listed —
Salicylic Acid 40 mg/241 63868-0042-24 Chain 24 patches — — FDA listed —
Salicylic Acid 40 mg/91 63941-0542-18 VALU 9 patches — — FDA listed —
Salicylic Acid 40 mg/41 63941-0543-04 VALU 4 patches — — FDA listed —
Salicylic acid 40 mg/41 63941-0551-04 VALU 4 patches — — FDA listed —
Corn Removers 400 mg/g 67091-0750-09 WinCo 9 patches — — FDA listed —
Yat Tip Tor 40 g 69070-0302-01 Zhejiang 1 pouch — — FDA listed —
Salicylic Acid 40 mg/91 69256-0030-09 Harris 9 patches — — FDA listed —
Salicylic Acid 40 mg/41 69256-0031-04 Harris 4 patches — — FDA listed —
Salicylic Acid 40 mg/61 69842-0201-06 CVS 6 patches — — FDA listed —
Salicylic Acid Wart Remover 40 mg 69842-0596-01 CVS 14 strips — — FDA listed —
Salicylic Acid 40 mg/181 72446-0002-18 Hudson 18 patches — — FDA listed —
Salicylic Acid 40 mg/41 72446-0003-04 Hudson 4 patches — — FDA listed —
Salicylic Acid 400 mg/g 72446-0015-01 Hudson 24 patches — — FDA listed —
Scholls Wellness Company LLC DS EXTRA THICK CALLUS REMOVER .4 g/g 73469-0463-01 Scholls 4 pouches — — FDA listed —
Scholls Wellness Company LLC DURAGEL CORN REMOVER .4 g/g 73469-0627-01 Scholls 6 pouches — — FDA listed —
Scholls Wellness Company LLC Clear Away Wart Removers 4 mg 73469-0631-01 Scholls 24 discs — — FDA listed —
Scholls Wellness Company LLC Duragel Callus Remover .4 g/g 73469-0644-01 Scholls 4 pouches — — FDA listed —
Scholls Wellness Company LLC One Step Corn Removers .4 g/g 73469-0753-01 Scholls 6 pouches — — FDA listed —
One Step Wart Removers .4 g/g 73469-6321-04 Scholls 14 pouches — — FDA listed —
Plantar Wart Removers .4 g/g 73469-6331-02 Scholls 12 pouches — — FDA listed —
Clear Away Wart Removers .4 g/g 73469-6421-02 Scholls 12 pouches — — FDA listed —
Biopure Medicated Wart Remover Strips .4 g/g 78691-0308-01 QUEST 8 pouches — — FDA listed —
Clear Corn Remover Strips 40 mg/121 79481-0594-01 MEIJER 6 patches — — FDA listed —
Clear Wart Remover Strips 40 mg/121 79481-0595-01 MEIJER 18 patches — — FDA listed —
Medicated Callus Removers 400 mg/g 79481-0609-01 Meijer 4 patches — — FDA listed —
Medicated Callus Removers Extra Thick 400 mg/g 79481-0611-01 Meijer 4 patches — — FDA listed —
Medicated Plantar Wart Remover 400 mg/g 79481-0619-01 Meijer 24 patches — — FDA listed —
Wart Removers 400 mg/g 79481-0620-01 Meijer 18 patches — — FDA listed —
Medicated Corn Removers 400 mg/g 79481-1613-01 Meijer 9 patches — — FDA listed —
Equate One-Step Medicated Corn Removers 40 mg/100mg 79903-0224-06 Walmart 6 patches — — FDA listed —
Equate One Step Wart Remover Strips 40 mg 79903-0226-01 Walmart 1 pouch — — FDA listed —
Wart Removers .4 g/g 81522-0076-01 FSA 18 pouches — — FDA listed —
Salicylic Acid 400 mg/g 81522-0910-01 FSA 9 patches — — FDA listed —
Salicylic Acid 400 mg/g 82442-0400-01 Target 9 patches — — FDA listed —
Scott Clear Corn Removers 40 mg/100mg 82660-0006-05 Creative 100 mg — — FDA listed —
Salicylic Acid 400 mg/g 83324-0229-01 Chain 9 patches — — FDA listed —
Salicylic Acid 400 mg/g 83324-0230-01 Chain 4 patches — — FDA listed —
Salicylic Acid 400 mg/g 83324-0231-24 Chain 24 patches — — FDA listed —
MQUPIN Corn Removal Pads 40 g/1001 83781-0001-01 Zhengzhou 24 patches — — FDA listed —
MYMULIKE Corn Removal Pads 40 g/1001 83781-0003-01 Zhengzhou 24 patches — — FDA listed —
Samsali Wart Corn Remover Pads 40 g/1001 83818-0004-01 Shenzhen 42 patches — — FDA listed —
TXL Active Wart Corn Remover Bandage 40 g/1001 83818-0009-01 Shenzhen 30 patches — — FDA listed —
SupreH Corn Remover Pads 40 g/1001 83818-0032-01 Shenzhen 24 patches — — FDA listed —
Wart Remover Pads .4 g 84735-0005-01 Hengyang 30 patches — — Discontinued —
BPLXKUR Wart Remover Bandaid .4 g 85578-0007-01 Zhengzhou 14 patches — — FDA listed —
Wart Corn Remover .4 g 85825-0002-01 Shenzhen 130691232 patches — — Discontinued —
Corn Remover Pads .4 g 85839-0004-01 Shenzhen 24300000 patches — — FDA listed —
WART Remover 40 g/1001 87255-0004-01 Shenzhen 144 patches — — FDA listed —
Corn Remover 40 U/100U 87308-0002-01 Shenzhen 42 us — — FDA listed —
GAVNZ WART REMOVER patches 40 g/1001 87786-0006-01 Wenzhou 180 patches — — 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

🏛️
2024
On the market since
May 2024
📍
2026
Currently FDA-listed
2 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

LabelerStrategic Sourcing Services LLC
FDA applicationM030 (OTC MONOGRAPH DRUG)
Labeler code70677
First marketedMay 2024
Product typeHuman Otc Drug
Portfolio316 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 10 words ▾

Uses for removal of corns relieves pain by removing corns

⏱️ Dosage and Administration 64 words ▾

Directions wash affected area, dry thoroughly If necessary, cut medicated disk to fit corn apply medicated disk with sitcky side adhereing to skin cover medicated disk with enclosed cushion after 48 hours, remove medicated disk repeat procedure every 48 hours as needed for up to 14 days (until corn is removed) may soak corn in warm water for 5 minutes to assist in removal

⚠️ Warnings 5 words ▾

Warning For external use only

📦 Storage and Handling 18 words ▾

Other Information Store between 20 o C to 25 o C (68 o F to 77 o F)

🧪 Active Ingredient 5 words ▾

Active Ingredient Salicylic Acid 40%

🧪 Inactive Ingredients 4 words ▾

Inactive Ingredient vinyl acetate

🎯 Purpose 3 words ▾

Purpose Corn Remover

📄 Do Not Use 24 words ▾

Do Not Use if you are a diabetic if you have poor blood circulation on irritated skin or area that is infected or reddened

📄 Stop Use and Ask a Doctor If 9 words ▾

Stop use and ask a doctor if disomfort lasts

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children If swallowed get medical help or contact a Poison Control Center right away. 800-222-1222

📄 Package Label / Principal Display Panel 6 words ▾

Foster & Thrive Corn Remover Label

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
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) — 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.
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 Strategic Sourcing Services LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Strategic Sourcing Services 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.
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.