Home › NDC Lookup › Ingredients › Benzalkonium Chloride, Lidocaine Hci › 69396-0136-10
Burn Cream Benzalkonium Chloride, Lidocaine HCI .005 g/g; .0013 g/g Cream, 10 packets — NDC 69396-0136-10 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Burn Cream Benzalkonium Chloride, Lidocaine HCI .005 g/g; .0013 g/g Cream, 10 packets — NDC 69396-136-10 (Billing 69396-0136-10)

by Trifecta Pharmaceuticals USA LLC · 10 PACKET in 1 CARTON / .9 g in 1 PACKET

This is a package of 10 packets of Burn Cream Benzalkonium Chloride, Lidocaine HCI .005 g/g; .0013 g/g Cream from Trifecta Pharmaceuticals USA LLC, marketed since Oct 2023 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 69396-0136-10
🏷️ FDA NDC (as labeled) 69396-136-10 billing pads the product segment with a zero
This package
Contains10 packets Pack sizes2 compare ↓
Main listing for product 69396-136 · Also comes in: 25 packets 69396-136-25
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Aug 27, 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 69396-136-10 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69396 labeler · 136 product · 10 package
Package marketed since
Oct 23, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0850058161266, 0766588195414
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69396-136-10
Product NDC 69396-136
11-digit billing NDC 69396013610
RxCUI 1012100
UNII V13007Z41A, F5UM2KM3W7
UPC 0850058161266, 0766588195414
Application # M003
SPL Set ID 087ac43c-1076-d1e2-e063-6294a90a5859
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-10-23
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE HYDROCHLORIDE; BENZALKONIUM CHLORIDE
Quick answers
  • RxCUI (RxNorm): 1012100
Why two NDCs? The FDA registers this code as 69396-136-10 — 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 → 69396-0136-10. 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 cream marketed as an over-the-counter monograph drug for minor burn care. It contains benzalkonium chloride, an antimicrobial agent typically used to help reduce bacteria on the skin, and lidocaine hydrochloride, a local anesthetic commonly used to numb minor pain and discomfort. The product is applied directly to the affected skin area.

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 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.
Try another pack size: 25 packets
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
69396-0136-10 You're viewing this Main listing 10 PACKET in 1 CARTON / .9 g in 1 PACKET 2023-10-23 — Active
69396-0136-25 69396-136-25 25 PACKET in 1 CARTON / .9 g in 1 PACKET 2023-10-23 — Active

Pack size FAQ

What quantity is in this package?
This package contains 10 packets — 10 packet in 1 carton / .9 g in 1 packet.
How does this package differ from NDC 69396-0136-25?
Both are Burn Cream Benzalkonium Chloride, Lidocaine HCI .005 g/g; .0013 g/g Cream — the drug itself is identical. This page's package is the 10 packets one, while NDC 69396-0136-25 is the 25 packets package.
What NDC number is used to bill for this package of Burn Cream Benzalkonium Chloride, Lidocaine HCI .005 g/g; .0013 g/g Cream?
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
First Aid Only First Aid/Burn 5 mg/g; 1.3 mg/g 00924-5011-00 Acme 9 g — — FDA listed —
First Aid Only First Aid-Burn 1.3 mg/g; 5 mg/g 00924-5702-00 Acme 9 g — — FDA listed —
First Aid Only First Aid/Burn 5 mg/g; 1.3 mg/g 00924-5730-00 Acme 9 g — — FDA listed —
Xpect First Aid Cream .13 g/100g; .5 g/100g 42961-0259-02 Cintas 9 g — — FDA listed —
GENUINE FIRST AID Antiseptic Pain Relieving .13 g/100g; .5 g/100g 43473-0015-01 Nantong 9 g — — FDA listed —
SAFLY Burn .5 g/100g; .13 g/100g 43473-0039-01 Nantong 9 g — — FDA listed —
Firstar Burn .5 g/100g; .13 g/100g 43473-0040-01 Nantong 9 g — — FDA listed —
Aosi Healthcare Burn .5 g/100g; .13 g/100g 43473-0055-01 Nantong 9 g — — FDA listed —
health and beyond BURN .5 g/100g; .13 g/100g 43473-0064-01 Nantong 9 g — — FDA listed —
Proheal Burn .5 g/100g; .13 g/100g 43473-0066-01 Nantong 9 g — — FDA listed —
Everlit Care Burn .5 g/100g; .13 g/100g 43473-0113-01 Nantong 9 g — — FDA listed —
Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0260-12 Unifirst 10 packets — — FDA listed —
Medi-First Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0270-12 Unifirst 10 packets — — FDA listed —
Green Guard Derma-Caine Burn 1.3 mg/g; 5 mg/g 47682-0319-35 Unifirst 144 packets — — FDA listed —
Medi-First Plus Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0930-73 Unifirst 25 packets — — FDA listed —
Medi-First Plus Burn Cream 5 mg/g; 1.3 mg/g 47682-0940-73 Unifirst 25 packets — — FDA listed —
Medi-First Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0984-73 Unifirst 25 packets — — FDA listed —
Medi-First Plus Burn with Lidocaine 1.3 mg/g; 5 mg/g 47682-0985-73 Unifirst 25 packets — — FDA listed —
Burn Treatment .13 g/100g; .5 g/100g 49687-0014-00 CMC 10 pouches — — FDA listed —
Refill 3 .13 g/100g; .5 g/100g 49687-0017-00 CMC 9 g — — FDA listed —
First Aid and Burn .13 g/100g; .5 g/100g 50332-0037-01 HART 6 packets — — FDA listed —
First Aid and Burn .13 g/100g; .5 g/100g 50332-0091-01 HART 6 packets — — FDA listed —
Refill 3 .13 g/100g; .5 g/100g 50814-0017-01 GFA 9 g — — FDA listed —
Genuine First Aid First Aid Antiseptic Pain Relieving Cream 1.3 mg/g; 5 mg/g 50814-0059-01 GFA 9 g — — FDA listed —
Genuine First Aid Pain Relieving Cream 1.3 mg/g; 5 mg/g 50814-0079-01 GFA 9 g — — FDA listed —
CareALL First Aid Burn Cream .005 g/g; .0013 g/g 51824-0096-14 New 144 packets — — FDA listed —
Be Smart Get Prepared Burn Cream .13 g/100g; .5 g/100g 55550-0521-01 Total 9 g — — FDA listed —
Burn Cream 1.3 mg/g; 5 mg/g 55550-0902-21 Total 9 g — — FDA listed —
First Aid Burn Cream .5 g/100g; .13 g/100g 58228-2044-02 ProStat 25 packets — — FDA listed —
First Aid Burn Cream 50 mg/10000mg; 13 mg/10000mg 58228-2309-01 ProStat 2000 packets — — FDA listed —
2677 First Aid Burn Cream 13 mg/10000mg; 50 mg/10000mg 58228-2677-01 ProStat 10 packets — — FDA listed —
Burn Cream .0013 g/g; .005 g/g 58228-7000-01 Prostat 25 packets — — FDA listed —
Burn Cream .0013 g/g; .005 g/g 58228-7010-01 Prostat 10 packets — — FDA listed —
First Aid Burn .5 g/100g; .13 g/100g 59898-0902-01 Water-Jel 1728 packets — — FDA listed —
First Aid and Burn 1.3 mg/g; 5 mg/g 61010-5701-04 Safetec 144 packets — — FDA listed —
Burn First Aid 50 mg/10000mg; 13 mg/10000mg 67777-0007-50 Dynarex 144 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0105-09 Trifecta 144 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0124-09 Trifecta 25 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/gthis 69396-0136-10 Trifecta 10 packets — — FDA listed —
Burn Cream .005 g/g; .0013 g/g 69396-0146-10 Trifecta 10 packets — — FDA listed —
ECOLAB Burn Cream 5 mg/g; 1.3 mg/g 71338-0123-73 ECOLAB 25 packets — — FDA listed —
Medi-First 5 mg/g; 1.3 mg/g 71927-0019-02 Orazen 25 pouches — — FDA listed —
Ever Ready First Aid 5 mg/g; 1.3 mg/g 72976-0005-01 Ever 9 g — — FDA listed —
First Shield 5 mg/g; 1.3 mg/g 72976-0008-01 Ever 9 g — — FDA listed —
Burn .5 g/100g; .13 g/100g 73288-0007-01 NINGBO 9 g — — FDA listed —
Thompson Burn Cream with Lidocain 1.3 mg/g; 5 mg/g 73408-0060-12 Thompson 10 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 5 mg/g; 1.3 mg/g 73408-0160-12 Thompson 10 packets — — FDA listed —
Crane Safety Burn 5 mg/g; 1.3 mg/g 73408-0260-12 Crane 10 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 1.3 mg/g; 5 mg/g 73408-0940-73 Thompson 25 packets — — FDA listed —
Thompson Burn Cream with Lidocaine 5 mg/g; 1.3 mg/g 73408-0985-73 Thompson 25 packets — — FDA listed —
First Aid Burn 5 mg/g; 1.3 mg/g 82749-0009-01 Epic 144 packets — — FDA listed —
First Aid Antiseptic Pain Relieving 1.3 mg/g; 5 mg/g 82996-0002-01 Hubei 9 g — — FDA listed —
First Aid Antiseptic Pain Relieving Cream 1.3 mg/g; 5 mg/g 83165-0004-00 Hubei 1 patch — — FDA listed —
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine Hydrochloride 1.3 mg/g; 5 mg/g 84219-0002-00 M-star 9 g — — FDA listed —
First Aid Burn 5 mg/g; 1.3 mg/g 87251-0009-01 4 144 packets — — 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
Oct 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.

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 ZY81Z83H0X
    Aloe vera leaf is a plant extract derived from the aloe plant. It is used in medicines as a natural moisturizer and skin-soothing agent in topical formulations.
  • 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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII KC98RO82HJ
    A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
  • 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 YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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 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 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.

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

The official label also statesAloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, 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

LabelerTrifecta Pharmaceuticals USA LLC
FDA applicationM003 (OTC MONOGRAPH DRUG)
Labeler code69396
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio67 products on file

More NDCs from Trifecta Pharmaceuticals USA LLC labeler code 69396

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 17 words ▾

Uses Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria.

⏱️ Dosage and Administration 22 words ▾

Directions Clean the affected area Apply a small amount not more than 3 times daily May be covered with a sterile bandage

⚠️ Warnings 38 words ▾

Warnings For external Use Only Do not use in eyes in large quantities over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns for more than one week unless directed by a doctor

📦 Storage and Handling 25 words ▾

Storage Information Store in cool dry area 15° to 25°C (59° to 77°F). tamper evident sealed packets do not use any opened or torn packets

🧪 Active Ingredient 8 words ▾

Active Ingredient Lidocaine HCL 0.5%

Benzalkonium Chloride 0.13%

🧪 Inactive Ingredients 29 words ▾

Inactive Ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Diazolidinyl urea, Edetate disodium, glycerin, methylparaben, Mineral oil, Mono and di glycerides, PEG-100 stearate, propylene glycol, propylparaben, stearic acid, triethanolamine, water

🎯 Purpose 7 words ▾

Purpose Topical Analgesic

Purpose First Aid Antiseptic

📄 Keep Out of Reach of Children 18 words ▾

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

📄 Questions or Comments 3 words ▾

Questions Call: 1-888-296-9067

📄 Package Label / Principal Display Panel 24 words ▾

Package Label R519-539 Globe First Aid Burn Cream 0.9g 10pk 102425 CDER

Package Label R519541 GLOBE FIRST AID BURN CREAM 0.9G 25CT 092623 CDER

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 ✓ 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 Trifecta Pharmaceuticals USA 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 1 other package presentation of this same product, including 25 packets (69396-0136-25). 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?
Trifecta Pharmaceuticals USA 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.
← 69396-0135-10 · Trifecta 69396-0137-10 · Trifecta →
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.