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Weeks and Leo Complete Lice Treatment Piperonyl butoxide, Pyrethrum extract Kit — NDC 11383-255-01 (Billing 11383-0255-01)

by Weeks & Leo Co., Inc. · 1 KIT in 1 CARTON * 118 mL in 1 BOTTLE

This is a package of Weeks and Leo Complete Lice Treatment Piperonyl butoxide, Pyrethrum extract Kit from Weeks & Leo Co., Inc., marketed since Oct 2010 and currently FDA-listed. It is this product's only package size.

NDC 11383-0255-01
🏷️ FDA NDC (as labeled) 11383-255-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 11383-255-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11383 labeler · 255 product · 01 package
Package marketed since
Jan 3, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1138325501 8
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11383-255-01
Product NDC 11383-255
11-digit billing NDC 11383025501
RxCUI 283219
Application # M031
SPL Set ID 499bdb9f-c235-3293-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-10-28
Route TOPICAL
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 283219
Why two NDCs? The FDA registers this code as 11383-255-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11383-0255-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

🧪 What is this product?

This is an over-the-counter topical lice treatment kit containing pyrethrum extract and piperonyl butoxide. Pyrethrum extract, derived from chrysanthemum flowers, is commonly used as an insecticide to kill lice. Piperonyl butoxide functions as an enhancer that works alongside the pyrethrum to improve its effectiveness. The kit is applied to the scalp and hair as part of a complete lice removal regimen.

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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
11383-0255-01 You're viewing this Main listing 1 KIT in 1 CARTON * 118 mL in 1 BOTTLE 2014-01-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Major Lice Killing .33 g/100mL; 4 g/100mL 00904-7349-20 Major 1 bottle $0.047 — Availability likely —
GNP Lice Killing .33 g/100mL; 4 g/100mL 46122-0759-29 AmerisourceBergen 1 bottle $0.047 — Availability likely —
Foster and Thrive Lice Killing .33 g/100mL; 4 g/100mL 70677-1184-01 Strategic 1 bottle $0.047 — Availability likely —
Lice Killing 4 g/100mL; .33 g/100mL 11383-0253-02 Weeks 1 bottle — — FDA listed —
Best Choice Lice Killing 4 g/100mL; .33 g/100mL 63941-0253-04 Valu 1 bottle — — FDA listed —
Herklin Lice Treatment 4 g/100mL; .33 g/100mL 75940-0192-09 MarcasUSA 59 ml — — FDA listed —
Walgreens Lice Killing 4 g/100mL; .33 g/100mL 00363-1253-02 Walgreens 1 bottle — — FDA listed —
Weeks and Leo Complete Lice Treatmentthis 11383-0255-01 Weeks 1 kit — — FDA listed —
Rite Aid Lice Killing .33 g/100mL; 4 g/100mL 11822-6616-01 Rite 1 bottle — — FDA listed —
Kroger Lice Killing .33 g/100mL; 4 g/100mL 30142-0253-08 The 1 bottle — — FDA listed —
Discount Drug Mart Lice Killing 4 g/100mL; .33 g/100mL 53943-0253-02 Discount 1 bottle — — FDA listed —
Discount Lice Treatment 53943-0255-01 Discount 1 kit — — FDA listed —
Family Wellness Lice Killing .33 g/100mL; 4 g/100mL 55319-0253-08 Family 1 bottle — — FDA listed —
Best Choice Lice Treatment 63941-0522-01 Associated 1 kit — — FDA listed —
CVS 3 Step Lice Solution 69842-0255-01 CVS 1 kit — — FDA listed —
Topcare Lice Killing .33 g/100mL; 4 g/100mL 76162-0253-08 Topco 1 bottle — — FDA listed —
Topcare Complete Lice Treatment Kit 76162-0255-01 Topco 1 kit — — FDA listed —
Mata Piojos Lice 4 g/100mL; .33 g/100mL 48201-0006-08 GRANDALL 1 bottle — — FDA listed —
Premier Value Lice Treatment Kit 68016-0552-01 PHARMACY 1 kit — — FDA listed —
ABC Lice Killing .33 g/100mL; 4 g/100mL 11383-0312-02 Weeks 1 bottle — — FDA listed —
Meijer Lice Killing .33 g/100mL; 4 g/100mL 79481-2530-08 Meijer, 1 bottle — — FDA listed —
Quality Choice Lice Treatment 83324-0268-01 Chain 1 kit — — FDA listed —
ZAP Lice Killing 4 g/100mL; .33 g/100mL 24286-0253-04 DLC 1 bottle — — FDA listed —
Rite Aid Complete Lice Elimination Kit 11822-6611-01 Rite 1 kit — — FDA listed —
GoodSense Complete Lice Treatment Kit 50804-0255-01 Perrigo 1 kit — — FDA listed —
El Piojito Lice Killing 4 g/100mL; .33 g/100mL 55758-0253-02 Pharmadel 1 bottle — — FDA listed —
Quality Choice Lice Killing 4 g/100mL; .33 g/100mL 83324-0269-04 Quality 1 bottle — — FDA listed —
GoodSense Lice Killing .33 g/100mL; 4 g/100mL 50804-0253-04 Perrigo 1 bottle — — FDA listed —
Meijer Complete Lice Treatment Kit 79481-2550-01 Meijer, 1 kit — — FDA listed —
Leader Lice Killing .33 g/100mL; 4 g/100mL 70000-0633-01 LEADER/ 1 bottle — — FDA listed —
Lice Killing 4 g/100mL; .33 g/100mL 68016-0253-04 PHARMACY 1 bottle — — FDA listed —
Walgreens Lice Elimination 00363-3255-01 Walgreens 1 kit — — FDA listed —
Lice No More Lice Killing 4 g/100mL; .33 g/100mL 11383-0001-04 Weeks 1 bottle — — FDA listed —
Lice Killing 4 g/100mL; .33 g/100mL 11383-0310-02 Weeks 1 bottle — — FDA listed —
Quita Piojos Lice Killing 4 g/100mL; .33 g/100mL 24286-1253-02 DLC 1 bottle — — FDA listed —
Kroger Complete Lice Treatment Kit 30142-0252-01 The 1 kit — — FDA listed —
CVS Health Lice Killing 4 g/100mL; .33 g/100mL 69842-0250-04 CVS 1 bottle — — 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

🏛️
2010
On the market since
Oct 2010
📍
2026
Currently FDA-listed
16 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.

From the label’s inactive-ingredient sectionammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

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.

Manufacturer & labeler

LabelerWeeks & Leo Co., Inc.
FDA applicationM031 (OTC MONOGRAPH DRUG)
Labeler code11383
First marketedOct 2010
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Weeks & Leo Co., Inc. labeler code 11383

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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 8 words ▾

Uses treats head, pubic (crab), and body lice

⏱️ Dosage and Administration ~1 min read ▾

Directions Important: Read warnings before use Adults and children 2 years and over: Inspect check each household member with a magnifying glass in bright light for lice/nits (eggs) look for tiny nits near scalp, beginning at back of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product Treat apply thoroughly to DRY HAIR or other affected area. For head lice, first apply behind ears and to back of neck. allow product to remain for 10 minutes, but no longer use warm water to form a lather, shampoo, then thoroughly rinse for head lice, towel dry hair and comb out tangles Remove lice and their eggs (nits) use a fine-tooth or special lice/nit comb.

Remove any remaining nits by hand (using a throw-away glove). hair should remain slightly damp while removing nits if hair dries during combing, dampen slightly with water for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours. lift a 1-to 2-inch wide strand of hair.

Place comb as close to scalp as possible and comb with a firm, even motion away from scalp. pin back each strand of hair after combing clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back. after combing, thoroughly recheck for lice/nits.

Repeat combing if necessary. check daily for any lice/nits that you missed a second treatment must be done in 7 to 10 days to kill any newly hatched lice if infestation continues, see a doctor for other treatments Children under 2 years : ask a doctor

⚠️ Warnings 122 words ▾

Warnings For external use only Do not use near eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas. Ask a doctor before use if you are allergic to ragweed.

May cause breathing difficulty or an asthmatic attack. When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 33 words ▾

Other information do not freeze store at controlled room temperature 20°-25°C (68°-77°F) to report serious side effects due to the use of this product call (515) 276-1586 see package insert for additional information

🧪 Active Ingredient 11 words ▾

Active ingredient Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

🧪 Inactive Ingredients 15 words ▾

Inactive ingredients ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

🎯 Purpose 3 words ▾

Purpose Lice treatment

📄 Do Not Use 26 words ▾

Do not use near eyes inside nose, mouth, or vagina on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

📄 Ask a Doctor Before Use If 19 words ▾

Ask a doctor before use if you are allergic to ragweed. May cause breathing difficulty or an asthmatic attack.

📄 When Using This Product 32 words ▾

When using this product keep eyes tightly closed and protect eyes with a washcloth or towel if product gets into eyes, flush with water right away scalp itching or redness may occur

📄 Stop Use and Ask a Doctor If 21 words ▾

Stop use and ask a doctor if breathing difficulty occurs eye irritation occurs skin or scalp irritation continues or infection occurs

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Patient Package Insert ~3 min read ▾

Package Insert Principal Display Panel Consumer Information LICE KILLING SHAMPOO For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice DIRECTIONS Important: Read warnings before using this product. A second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits) Inspect examine each household member with a magnifying glass in bright light for lice/eggs (nits) look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears examine small sections of hair eggs (nits) stick to the hair if either lice or eggs (nits) are found, treat with this product Treat apply thoroughly to dry hair or other affected area.

For head lice, first apply behind ears and to back of neck allow product to remain for 10 minutes but no longer use warm water to form a lather, shampoo, then thoroughly rinse for head lice, towel dry hair and comb out tangles To Remove Lice and Their Eggs (Nits) use a special lice/nit or fine-toothed comb (included). Remove any remaining eggs (nits) by hand, using a throwaway glove hair should remain slightly damp while removing eggs (nits) if hair dries during combing, dampen slightly with water for head lice, part hair into sections.

Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours lift a 1- to 2-inch wide strand of hair. Place comb firm, even motion away from scalp pin back each strand of hair after combing clean comb often.

Wipe eggs (nits) away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back after combing, thoroughly recheck for lice/eggs (nits). Repeat combing if necessary check daily for any lice/eggs (nits) that you missed a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits) if infestation continues, see a doctor for other treatments 1.

HEAD LICE head lice lay small white eggs (nits) on the hair shaft close to the scalp eggs (nits) are most easily found on the back of the neck or behind the ears disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes items that cannot be washed, dry cleaned or stored may be sprayed with a product designed for this purpose soak all combs and brushes in hot water [above 54 C (130 F)] for at least 10 minutes vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people 2.

PUBIC (CRAB) LICE pubic (crab) lice may be contracted by sexual contact sexual partners should be treated simultaneously to avoid reinfestation lice are very small and look like brown or grey dots on the skin pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache disinfect underwear by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes 3.

BODY LICE body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas body lice feed on skin then return to clothing to lay their eggs (nits) disinfect clothing by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 mintues do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 days Save this insert for future reference SHAKE WELL BEFORE USING CHAMPÚ PARA MATAR PIOJOS Para el tratamiento de piojos de cabeza, piojos púbicos (ladillas) y piojos del cuerpo Para uso externo solamente.

No lo use cerca de los ojos dentro de la nariz, boca o vagina para piojos en las cejas o pestañas. Consulte a un doctor si hay piojos en estas áreas. Pregúntele a un doctor antes de usarlo si es alérgico a la ambrosía.

Puede… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 77 words ▾

Principal Display Panel WEEKS&LEO Complete Lice Treatment Kit Kills Lice Safe, Effective & Fast Eliminates Lice from Your Home & Family For Human Use NDC 11383-255-01 Compare to the Active Ingredients in RID® Lice Killing Shampoo CAUTION: KEEP OUT OF REACH OF CHILDREN See back and side panels for additional information Instrucciones en español incluidas 4 fl oz (118 mL) Lice Treatment Shampoo Net Wt. 5 oz (142 g) Lice, Bedbug & Mite Spray Principal Display Panel

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 Piperonyl butoxide, Pyrethrum extract — the ingredient across all brands.

Top reported reactions

Abdominal Pain1
Application Site Pain1
Chemical Burn1
Crying1
Diarrhoea1
Drug Resistance1
Emotional Distress1

Reporter sex

6 reports
Male · 17%
Female · 67%
Unknown · 17%

Serious outcomes

Hospitalization2
Life-threatening1
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product 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) — 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 Weeks & Leo Co., Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Weeks & Leo Co., 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.
← 11383-0253-02 · Weeks 11383-0256-04 · Weeks →
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.