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Gelle-N-Detox - Lavender and Rosemary Massage Benzalkonium Chloride .1 g/100g Lotion, 20 g — NDC 49283-0001-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gelle-N-Detox - Lavender and Rosemary Massage Benzalkonium Chloride .1 g/100g Lotion, 20 g — NDC 49283-001-07 (Billing 49283-0001-07)

by CHEMCO CORPORATION · 20 g in 1 POUCH

This is a package of 20 g of Gelle-N-Detox - Lavender and Rosemary Massage Benzalkonium Chloride .1 g/100g Lotion from CHEMCO CORPORATION, marketed since Jan 2023 and currently FDA-listed, this package's marketing is listed to end Dec 2027. It is this product's only package size.

NDC 49283-0001-07
🏷️ FDA NDC (as labeled) 49283-001-07 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ 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 49283-001-07 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
49283 labeler · 001 product · 07 package
Package marketed since
Jan 18, 2023
Package marketing ended
Dec 31, 2027
Sample package
No — commercial package
Barcode (UPC-A, from the NDC)
3 4928300107 7
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Benzalkonium Chloride (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 · Apr 8, 2026 — CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0693-2026
Class II · Apr 8, 2026 — CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated (Blaine Labs Inc) · FDA recall D-0699-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0375-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0369-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0365-2026
Class II · Jan 20, 2026 — CGMP Deviations (ACME UNITED CORPORATION) · FDA recall D-0374-2026
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) 49283-001-07
Product NDC 49283-001
11-digit billing NDC 49283000107
RxCUI 1102185
UNII F5UM2KM3W7
Application # M003
SPL Set ID f28c2c1e-7d0a-45b9-e053-2995a90a4710
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-01-18
Marketing end 2027-12-31
Route TOPICAL
Dosage form LOTION
Substance BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1102185
Why two NDCs? The FDA registers this code as 49283-001-07 — 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 → 49283-0001-07. 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 Quaternary ammonium compounds class.

Drug family (ATC) Quaternary ammonium compounds, Medicated dressings with antiinfectives, Antiseptics
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 lotion marketed as an over-the-counter monograph drug under FDA guidelines for its category. It contains benzalkonium chloride, an antimicrobial agent that is commonly used in topical products to help reduce bacteria and other microorganisms on the skin. The lotion also includes lavender and rosemary, ingredients often added for their fragrance and traditional use in massage products. This product is intended for external application only.

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 gPer 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
49283-0001-07 You're viewing this Main listing 20 g in 1 POUCH 2023-01-18 Dec 31, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100gthis 49283-0001-07 CHEMCO 20 g — — FDA listed —
Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0014-07 CHEMCO 20 g — — Discontinued —
Gelle-N-Detox - Lavender And Rosemary Massage .1 g/100g 49283-0015-07 CHEMCO 20 g — — Discontinued —
Gelle-N-Detox Ice Mint And Eucalyptus Massage .1 g/100g 49283-0110-07 CHEMCO 20 g — — FDA listed —
Dial Antibacterial Calm and Soothe .1 g/100g 54340-0266-03 Henkel 3 packets — — FDA listed —
Dial Complete Antibacterial Bar Spring Water .1 g/100g 54340-0270-08 Henkel 8 packets — — FDA listed —
Dial refresh and renew Antibacterial Bar Spring Water .1 g/100g 54340-0300-01 Henkel 113 g — — FDA listed —
Escudo Ultra-Protect Original .1 g/100g 84529-0001-01 Indelpa, 115 g — — FDA listed —
Dial refresh and renew Antibacterial Mountain Fresh .1 g/100g 54340-0017-03 Henkel 3 packets — — FDA listed —
Dial Antibacterial with Vitamins .1 g/100g 54340-0020-01 Henkel 113 g — — FDA listed —
Dial refresh and renew Antibacterial white .1 g/100g 54340-0260-01 Henkel 113 g — — FDA listed —
Escudo Ultra-Protect Soft Care .1 g/100g 84529-0002-01 Indelpa, 115 g — — FDA listed —
Dial antibacterial and sensitive hypoallergenic bar .1 g/100g 54340-0283-30 Henkel 1 cello — — FDA listed —
Klean-Them Hand Sanitizing Towels .1 g/100g 73943-0953-01 Rite-Kem, 400 g — — FDA listed —
5EWA5 Antibacterial Hand Sanitizer Wipes .1 g/100g 40096-1909-01 W.W. 6 canisters — — Discontinued —
SCRUBS Hand Sanitizer Wipes .1 g/100g 51239-2909-01 ITW 400 g — — FDA listed —
Dial advanced clean Antibacterial gold .1 g/100g 54340-0262-01 Henkel 113 g — — FDA listed —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2023
On the market since
Jan 2023
📍
2026
Currently FDA-listed
3 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color purple
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 7X6O37OK2I
    A synthetic fragrance compound used as a flavoring agent or aromatic component in medicines. It adds pleasant taste or smell to make the medication more acceptable to patients.
  • UNII P01OUT964K
    A fragrant plant-derived alcohol used as a flavoring agent and fragrance component in medicines. It provides taste and aroma to make the product more pleasant to use.
  • UNII 0370GZL32F
    A mixture of amino acids derived from wheat protein. Used as a nutrient supplement and binding agent to help hold tablet or capsule ingredients together while improving nutritional profile.
  • UNII 4V59G5UW9X
    Argan oil is a plant-derived oil from argan tree kernels. It's used in medicines as an emollient and skin-conditioning agent to help soften and moisturize the product's texture.
  • UNII WAO5MNK9TU
    Benzyl salicylate is a fragrant chemical compound used as a flavor and scent ingredient in medicines. It helps mask unpleasant tastes or odors in liquid or oral formulations.
  • UNII T7540GJV69
    A synthetic fragrance compound used as a flavor or scent ingredient in medicines. It helps mask unpleasant tastes or odors in the formulation to make the medication more palatable.
  • UNII 936JST6JCN
    Cetyl alcohol is a waxy, fatty substance derived from plant or animal sources. It acts as an emulsifier and thickener in medicines, helping blend oil and water components and giving products a smooth, creamy texture.
  • UNII Q9L0O73W7L
    Coconut oil is a natural fat extracted from coconut fruit. It's used in medicines as a lubricant, emollient, or carrier to help dissolve or deliver active ingredients smoothly through the formulation.
  • UNII 350KA7O6HK
    D&C Violet No. 2 is a synthetic purple dye approved by the FDA for use in medicines. It serves as a colorant to make tablets, capsules, or liquids visually distinct for identification purposes.
  • UNII BYR0546TOW
    DMDM hydantoin is a preservative chemical used to prevent the growth of bacteria and fungi in medicines. It helps keep the product safe and stable throughout its shelf life.
  • UNII L837108USY
    Geraniol is a natural fragrant compound found in plants like roses and lemons. It's used in medicines as a flavoring agent and to improve the taste or aroma of the product.
  • UNII YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII RMB44WO89X
    Hydroxyproline is an amino acid derived from collagen. In medications, it serves as a structural component or filler that may help provide stability and texture to the formulation.
  • UNII 9XP4LC555B
    A fragrance compound derived from natural plant sources or made synthetically. It's added to medicines as a flavoring agent to mask bitter tastes and improve how the medicine smells and tastes.
  • UNII 51217XIL5L
    A plant material derived from lavender flowers, used as a natural flavor and fragrance agent in medicines to improve taste and aroma.
  • UNII D81QY6I88E
    Linalool is a natural fragrant oil found in plants like lavender and citrus. It's used in medicines as a flavoring agent and to mask unpleasant tastes or smells.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII WV9CM0O67Z
    Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
  • UNII Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • UNII EA3289138M
    A plant extract from rosemary that acts as a natural preservative and antioxidant in medicines. It helps prevent oils and fats in the formulation from breaking down and going bad.
  • UNII 469OTG57A2
    Sodium pyrrolidone carboxylate is a synthetic polymer derived from pyrrolidone chemistry. It functions as a solubilizer and binder in medications, helping dissolve poorly water-soluble drugs and hold tablet ingredients together.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • UNII H8FJJ6KX5Y
    A plant extract from comfrey, used as a natural emollient and skin-conditioning agent in topical formulations to help soften and soothe the product texture.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • UNII 9O3K93S3TK
    Trolamine is an alkaline compound used as a pH buffer and emulsifier in medicines. It helps neutralize acids, stabilize formulations, and enable mixing of oil and water-based ingredients.
  • 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.

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

The official label also statesWater (Aqua), Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Fragrance (Parfum), Stearyl Alcohol, DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, D&C Violet No.2 (CI 60730), Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha Isomethyl Ionone, Citronellol, Geraniol.

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

LabelerCHEMCO CORPORATION
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code49283
First marketedJan 2023
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from CHEMCO CORPORATION labeler code 49283

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 7 words ▾

USES: To decrease bacteria on the skin.

⏱️ Dosage and Administration 19 words ▾

DIRECTIONS: Apply a full-palm amount or as needed to cover the affected area (hands, feet, body). Rub until absorbed.

⚠️ Warnings 25 words ▾

For external use only. Do not use on wounds or damaged skin, with a heating pad or on a child under 12 years of age.

🧪 Active Ingredient 3 words ▾

Benzalkonium Chloride 0.1%

🧪 Inactive Ingredients 66 words ▾

Water (Aqua), Paraffinum Liquidum, Stearic Acid, Cetyl Alcohol, Fragrance (Parfum), Stearyl Alcohol, DMDM Hydantoin, Triethanolamine, Acrylamide/Sodium Acrylate Copolymer, Trideceth-6, Methylparaben, Propylparaben, Cocos Nucifera Oil (Organic), Argania Spinosa Kernel Oil (Organic), Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, D&C Violet No.2 (CI 60730), Benzyl Salicylate, Linalool, Hexyl Cinnamal, Alpha Isomethyl Ionone, Citronellol, Geraniol.

🎯 Purpose 1 words ▾

Antimicrobial

📄 Ask a Doctor Before Use If 12 words ▾

Ask a doctor before use if you have redness over affected area.

📄 When Using This Product 17 words ▾

Avoid contact with the eyes. Do not apply to the irritated skin or if excessive irritation develops.

🤰 If Pregnant or Breast-Feeding 6 words ▾

Ask a health professional before use.

📄 Keep Out of Reach of Children 13 words ▾

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

📄 Other Information 16 words ▾

Store tightly closed in a dry place at controlled room temperature between 59°-86° F (15°-30° C).

📄 Questions or Comments 3 words ▾

Call (305) 623-4445

📄 Package Label / Principal Display Panel 11 words ▾

GELLE-N-DETOX LAVENDER & ROSEMARY MASSAGE LOTION 0.7 oz ANTIBACTERIAL LOTION LAVENDER

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 GELLE-N-DETOX - LAVENDER AND ROSEMARY MASSAGE (this brand).

Top reported reactions

Drug Hypersensitivity118
Condition Aggravated114
Arthralgia112
Musculoskeletal Stiffness111
Pain In Extremity111
Infection110
Hepatotoxicity108

Reporter sex

331 reports
Male · 28%
Female · 72%
Unknown · 0%

Serious outcomes

Death25
Disabling18
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 35 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 it is currently marketed — but CHEMCO CORPORATION has reported a marketing end date of 2027-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
CHEMCO CORPORATION 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.
← 49281-0926-50 · Sanofi 49283-0014-07 · CHEMCO →
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.