HomeNDC LookupIngredientsSodium Chloride › 51879-0122-88
Licefreee Sodium chloride Kit — NDC 51879-0122-88 package photo

Licefreee Sodium chloride Kit

by Tec Laboratories, Inc. · 1 KIT in 1 KIT (51879-122-88) * 227 g in 1 BOTTLE, PLASTIC (51879-121-80) * 236.6 mL in 1 BOTTLE, PLASTIC (51879-191-08)
NDC 51879-0122-88
🏷️ FDA NDC (as labeled) 51879-122-88 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Sodium 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 2, 2026 — Lack of Assurance of Sterility (Huons Co., Ltd.) · FDA recall D-0531-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0433-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0427-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0425-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0429-2026
Class II · Mar 11, 2026 — Lack of Assurance of Sterility (Fresenius Kabi USA, LLC) · FDA recall D-0431-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51879-122-88
Product NDC 51879-122
11-digit billing NDC 51879012288
SPL Set ID 40b8dd81-fd8b-602e-e054-00144ff8d46c
DEA schedule Non-controlled
Marketing category UNAPPROVED HOMEOPATHIC
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-07-13
Route TOPICAL
Dosage form KIT
Why two NDCs? The FDA registers this code as 51879-122-88 — 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 → 51879-0122-88. 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.

🏭 Manufacturer & labeler

LabelerTec Laboratories, Inc.
Labeler code51879
First marketedJul 2016
Product typeHuman Otc Drug
Portfolio3 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Yes, exactly. Saline is just sodium chloride dissolved in water — it's essentially a sterile salt-water solution. Depending on the concentration and form, it can be used as an IV f...
  • I've heard of saline solution — is that the same thing as sodium chloride?
  • In some situations — like after surgery, during serious illness, or when someone can't take anything by mouth — the body needs fluids and electrolytes delivered directly into the b...
  • Why would someone need sodium chloride through an IV? Can't you just drink water?
📖 Read our full Sodium Chloride guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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 sectionInactive ingredients benzyl alcohol, cocamidopropyl betaine, disodium EDTA, fragrances, polyquaternium 10, purified water, sodium lauryl sulfate, tea tree oil Inactive Ingredients aminomethyl propanol, anise oil, carbomer, cocamidopropyl betaine, fragrance, PEG-6 caprylic/capric glycerides, purified water

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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Licefreee Everyday 1 [hp_X]/mL 51879-0191-08 Tec 236.6 ml FDA listed
Licefreeethis 51879-0122-88 Tec 1 kit 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

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Sodium Chloride (matched by generic name) — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Sodium Chloride. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$16.2K
Claims incl. refills
266
Beneficiaries
53
Spend / beneficiary
$304.99
Spend / claim
$60.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 Licefreee (this brand).

Top reported reactions

Nausea5,254
Myelosuppression5,168
Dyspnoea4,604
Headache4,257
Pyrexia4,195
Fatigue4,058
Vomiting3,745

Age at onset

Neonate122
Infant128
Child819
Adolescent624
Adult8,741
Elderly4,772

Reporter sex

73,152 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization33,215
Life-threatening4,970
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,388 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51879-0122-88 You're viewing this 1 KIT in 1 KIT (51879-122-88) * 227 g in 1 BOTTLE, PLASTIC (51879-121-80) * 236.6 mL in 1 BOTTLE, PLASTIC (51879-191-08) 2016-07-13 Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing Kit / multi-component package

About homeopathic listings

Licefreee Sodium chloride KIT is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

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 ✓ 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 "Unapproved Homeopathic". 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 FDA registers it as 51879-122-88, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 51879-0122-88, written without dashes as 51879012288. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 51879-0122-88, the first segment (51879) is the labeler code FDA assigned to Tec Laboratories, Inc.; the middle segment (0122) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (88) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Tec Laboratories, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Tec Laboratories, 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.

📄 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 24 words

Uses Use daily to help avoid head lice reinfestation.

Uses ■For the treatment of ■ head lice ■ pubic (crab) lice ■ body lice

⏱️ Dosage and Administration ~1 min read

Directions Adults and children 6 months and older: for best results on a head lice infestation, use Licefreee Spray!® or Licefreee!® Gel treatment before using this shampoo. apply a generous amount of shampoo to wet hair, work into a lather while massaging into scalp; rinse repeat, this time leaving the shampoo on the hair for 3 minutes; rinse use daily for at least 7-10 days to treat any lice that have hatched. Children under 6 months: do not use; consult a doctor

Directions adults and children 6 months of age and older: shake well remove cap and tamper evident seal; replace with enclosed root applicator apply to DRY hair and entire scalp, starting at the nape of the neck and behind ears (where lice congregate) and work forward thoroughly saturate all hair and scalp; to be effective, all lice and nits must come in full contact with the product put plastic cap on head and leave on for at least 60 minutes; for best results stay in a warm room never leave child unattended with plastic cap on with product still in hair, remove plastic cap and comb out all dead lice and nits with enclosed fine toothed comb; rinse comb out under running water once all lice and nits are combed out, rinse hair thoroughly with warm running water thoroughly inspect and comb hair and scalp a second time to ensure complete removal of all lice and nits Licefreee! may be used as often as necessary; a second treatment in 7-10 days is recommended to kill any newly hatched lice children under 6 months of age: do not use, consult a doctor

⚠️ Warnings 10 words

Warnings For external use only.

Warnings For external use only

📦 Storage and Handling 16 words

Other information store at 59-86°F (15-30°C)

Other Information​ Store at 59 - 86°F (15 - 30°C)

🧪 Active Ingredient 25 words

Licefreee Shampoo Everyday! Active Ingredient Natrum muriaticum 1X 10% HPUS (Sodium chloride)

Licefreee! Gel Lice Treatment Active Ingredient Natrum muriaticum 1X 10% HPUS (Sodium chloride)

🧪 Inactive Ingredients 34 words

Inactive ingredients benzyl alcohol, cocamidopropyl betaine, disodium EDTA, fragrances, polyquaternium 10, purified water, sodium lauryl sulfate, tea tree oil

Inactive Ingredients aminomethyl propanol, anise oil, carbomer, cocamidopropyl betaine, fragrance, PEG-6 caprylic/capric glycerides, purified water

🎯 Purpose 6 words

Purpose Pediculosis remedy

Purpose Pediculosis remedy

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