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Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL Liquid, 355 mL — NDC 49580-0272-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL Liquid, 355 mL — NDC 49580-0272-2 (Billing 49580-0272-02)

by P & L Development, LLC · 355 mL in 1 BOTTLE, PLASTIC

This is a package of 355 mL of Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL Liquid from P & L Development, LLC, marketed since Jun 2014 and currently FDA-listed. It is the main listing for this product, which comes in 3 package sizes.

NDC 49580-0272-02
🏷️ FDA NDC (as labeled) 49580-0272-2 billing pads the package segment with a zero
This package
Contains355 mL Pack sizes3 compare ↓
Main listing for product 49580-0272 · Also comes in: 473 ml 49580-0272-6 946 ml 49580-0272-3
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 49580-0272-2 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49580 labeler · 0272 product · 2 package
Package marketed since
Jun 30, 2014
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0715256900072
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Isopropyl Alcohol (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 · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0373-2026
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0604-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0601-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0602-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0600-2025
Class II · Jul 7, 2025 — Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. (MEDLINE INDUSTRIES, LP - Northfield) · FDA recall D-0605-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 49580-0272-2
Product NDC 49580-0272
11-digit billing NDC 49580027202
RxCUI 616456
UNII ND2M416302
UPC 0715256900072
Application # M003
SPL Set ID f9ff67b0-c4ad-4162-b3ef-27a85ed0da25
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-06-30
Route TOPICAL
Dosage form LIQUID
Substance ISOPROPYL ALCOHOL
Quick answers
  • RxCUI (RxNorm): 616456
Why two NDCs? The FDA registers this code as 49580-0272-2 — 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 → 49580-0272-02. 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 Other antiseptics and disinfectants class.

Drug family (ATC) Other antiseptics and disinfectants
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

🧪 What is this product?

This is a topical liquid containing isopropyl alcohol as an antiseptic, marketed as an over-the-counter monograph product. Isopropyl alcohol is commonly used on skin to help reduce bacteria and prepare the skin before minor procedures or injections. The product is supplied in a 50 milliliter bottle and is intended for external use only.

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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 473 ml 946 ml
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
49580-0272-02 You're viewing this Main listing 355 mL in 1 BOTTLE, PLASTIC 2014-06-30 — Active
49580-0272-03 49580-0272-3 946 mL in 1 BOTTLE, PLASTIC 2014-06-30 — Active
49580-0272-06 49580-0272-6 473 mL in 1 BOTTLE, PLASTIC 2014-06-30 — Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 355 mL — 355 ml in 1 bottle, plastic.
How does this package differ from NDC 49580-0272-06?
Both are Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL Liquid — the drug itself is identical. This page's package is the 355 mL one, while NDC 49580-0272-06 is the 473 ml package.
What NDC number is used to bill for this package of Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mL Liquid?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Isopropyl 50 mL/100mL 00869-0211-40 Vi-Jon, 355 ml — — Discontinued —
50% Rubbing 50 mL/100mL 00869-0864-18 Vi-Jon, 118 ml — — Discontinued —
Isopropyl Alcohol 50% 50 mL/100mL 10565-0003-04 Hydrox 118 ml — — FDA listed —
Isopropyl Alcohol with Wintergreen 50% 50 mL/100mL 10565-0007-04 Hydrox 118 ml — — FDA listed —
Isopropyl 50 mL/100mL 11344-0112-43 Nice-Pak 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 mL/100mL 30400-0100-01 Jell 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 30400-0101-01 Jell 119 ml — — FDA listed —
Isopropyl 50 mL/100mL 37808-0055-43 H 473 ml — — FDA listed —
50 percent Isopropyl alcohol 50 mL/100mL 42681-6573-01 Whole 473 ml — — FDA listed —
Isopropyl alcohol 50 percent 50 mL/100mL 49035-0271-16 EQUATE 473 ml — — FDA listed —
Isopropyl alcohol 50 percent 50 mL/100mL 49035-0272-16 EQUATE 473 ml — — FDA listed —
Isopropyl alcohol 50 percent Wintergreen ReadyInCase 50 mL/100mLthis 49580-0272-02 P 355 ml — — FDA listed —
50% Rubbing 50 mL/100mL 50804-0864-43 Perrigo 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 51628-4232-01 MY 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 51628-4233-01 My 355 ml — — FDA listed —
American Red Cross 50% Isopropyl Rubbing Alcohol 500 mg/mL 51628-4239-01 MY 177 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 51628-4240-01 MY 177 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52000-0050-01 Universal 118 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% with Wintergreen 50 mL/100mL 52000-0051-01 Universal 118 ml — — FDA listed —
Universal 50% Rubbing Alcohol 50 mL/100mL 52000-0410-32 Universal 946 ml — — FDA listed —
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin 50 mL/100mL 52000-0412-32 Universal 946 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 mL/100mL 52000-0801-01 Universal 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52000-0802-01 Universal 119 ml — — FDA listed —
Novita Isopropyl Alcohol 50% 50 mL/100mL 52410-1050-04 Shield 355 ml — — FDA listed —
Novita 50% Isopropyl Rubbing Alcohol W/ Wintergreen 50 mL/100mL 52410-1051-04 Shield 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% 50 mL/100mL 52862-0022-03 Home 119 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 52862-0023-03 Home 119 ml — — FDA listed —
Isopropyl alcohol 50 mL/100mL 55319-0569-16 Family 473 ml — — FDA listed —
Isopropyl 50 mL/100mL 55910-0211-43 Old 473 ml — — FDA listed —
50% Rubbing 50 mL/100mL 55910-0864-38 Old 296 ml — — Discontinued —
Isopropyl Rubbing Alcohol 50 mL/100mL 58037-0002-01 New 355 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50% With Wintergreen 50 mL/100mL 58037-0005-01 New 355 ml — — FDA listed —
50% Isopropyl Alcohol 50 mL/100mL 59640-0864-43 H 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol Orazen Inc 50 mL/100mL 71927-0025-01 Orazen 354 ml — — Discontinued —
Isopropyl Rubbing Alcohol Wintergreen Orazen Inc 50 mL/100mL 71927-0026-01 Orazen 354 ml — — Discontinued —
50% Isopropyl Alcohol 500 mg/mL 72288-0864-43 Amazon.com 473 ml — — FDA listed —
Isopropyl Rubbing Alcohol 50 Percent 50 mL/100mL 72520-0315-12 JC 355 ml — — FDA listed —
Rubbing Alcohol 50 Percent 50 mL/100mL 76436-0321-12 Viny 355 ml — — FDA listed —
Rubbing Alcohol 50 mL/100mL 78440-0009-01 INTERNATIONAL 354 ml — — FDA listed —
Nexxgen 50% Rubbing Alcohol 50 mL/100mL 83629-0019-32 A 946 ml — — FDA listed —
Wish Rubbing Alcohol 50% 50 mL/100mL 84809-0009-01 LJ 12 bottles — — FDA listed —
WISH RUBBING ALCOHOL 50% Winter Green 50 mL/100mL 84809-0010-01 LJ 12 bottles — — FDA listed —
Our Brand 50% Isopropyl Rubbing Alcohol 50 mL/100mL 85891-0001-01 SPARROW 354 ml — — Discontinued —
Our Brand 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 85891-0002-01 SPARROW 354 ml — — Discontinued —
Doue 50% Isopropyl Rubbing Alcohol 50 mL/100mL 87510-0002-01 ONEST 355 ml — — FDA listed —
Doue 50% Isopropyl Rubbing Alcohol With Wintergreen 50 mL/100mL 87510-0003-01 ONEST 355 ml — — FDA listed —
Isopropyl Alcohol 50 mL/100mL 11344-0864-43 Nice-Pak 473 ml — — 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

🏛️
2014
On the market since
Jun 2014
📍
2026
Currently FDA-listed
12 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.

What it looks like

Color green
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 3P3ONR6O1S
    A synthetic green dye approved by the FDA for use in medicines and foods. It serves as a colorant to make the pill or liquid visually distinctive and help with product identification.
  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • UNII LAV5U5022Y
    Methyl salicylate is a naturally derived liquid compound commonly found in wintergreen plants. In medicines, it's used as a flavoring agent and penetrating solvent to help distribute active ingredients evenly throughout topical products.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

4 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesFD&C green #3, FD&C yellow #5, methyl salicylate, purified water

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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

LabelerP & L Development, LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code49580
First marketedJun 2014
Product typeHuman Otc Drug
Portfolio124 products on file

More NDCs from P & L Development, LLC labeler code 49580

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 16 words ▾

Uses first aid to help prevent the risk of infection in minor cuts, scrapes and burns

⏱️ Dosage and Administration 28 words ▾

Directions clean affected area apply small amount of this product on the area 1-3 times daily if bandaged, let dry first may be covered with a sterile bandage

⚠️ Warnings 111 words ▾

Warnings For external use only if taken internally serious gastric disturbances will result Flammable, keep away from fire or flame. use only in a well-ventilated area; fumes may be toxic Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns When using this product do not get into eyes do not apply over large areas of the body do not use longer than one week unless directed by a doctor Stop use and ask a doctor if condition persists or gets worse Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

🧪 Active Ingredient 8 words ▾

Active ingredient (by volume) Isopropyl alcohol (50% conc.)

🧪 Inactive Ingredients 12 words ▾

Inactive ingredients FD&C green #3, FD&C yellow #5, methyl salicylate, purified water

🎯 Purpose 4 words ▾

Purpose first aid antiseptic

📄 Ask a Doctor Before Use If 17 words ▾

Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns

📄 When Using This Product 30 words ▾

When using this product do not get into eyes do not apply over large areas of the body do not use longer than one week unless directed by a doctor

📄 Stop Use and Ask a Doctor If 12 words ▾

Stop use and ask a doctor if condition persists or gets worse

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of ingestion, get medical help or contact a Poison Control Center right away (1-800-222-1222).

📄 Package Label / Principal Display Panel 87 words ▾

Principal Display Panel 50% Rubbing Alcohol Isopropyl wintergreen first aid antiseptic WARNING keep away from heat, spark, electrical, fire or flame FLAMMABLE USE ONLY IN A WELL-VENTILATED AREA; FUMES MAY BE TOXIC Manufactured by: PL Developments 513 Old Griffin Road Piedmont, SC 29673 Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST WARNING: FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER THE CAP IS BROKEN OR MISSING. FL OZ(mL)

Package Label READYinCASE First Aid Antiseptic Isopropyl alcohol (50% conc.)

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 Isopropyl alcohol 50 percent Wintergreen ReadyInCase (this brand).

Top reported reactions

Pemphigus1,529
Glossodynia1,527
Hand Deformity1,508
Joint Swelling1,506
Helicobacter Infection1,501
Infusion Related Reaction1,494
Systemic Lupus Erythematosus1,490

Age at onset

Neonate24
Adolescent1
Adult604
Elderly23

Reporter sex

3,540 reports
Male · 2%
Female · 98%
Unknown · 0%

Serious outcomes

Life-threatening2,465
Reports over time (by year) — tap or hover for the count & year
2020 2022 2024 2026 309 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
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by P & L Development, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 473 ml (49580-0272-06), 946 ml (49580-0272-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
P & L Development, 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.
← 49580-0268-03 · P 49580-0275-03 · P →
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.