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Lemon Glycerin .3 g/4g Swab, 25 applicators — NDC 67777-0161-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Lemon Glycerin .3 g/4g Swab, 25 applicators — NDC 67777-161-11 (Billing 67777-0161-11)

by Dynarex Corporation · 25 APPLICATOR in 1 BOX / .3 g in 1 APPLICATOR

This is a package of 25 applicators of Lemon Glycerin .3 g/4g Swab from Dynarex Corporation, marketed since Dec 2019 and currently FDA-listed.

NDC 67777-0161-11
🏷️ FDA NDC (as labeled) 67777-161-11 billing pads the product segment with a zero
This package
Contains25 applicators Pack sizes2 compare ↓
Product page 67777-0161-10 Also comes in: 25 applicators 67777-161-10
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 67777-161-11 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
67777 labeler · 161 product · 11 package
Package marketed since
Dec 18, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Billing quantity
25 EA per package
Barcode (UPC)
0616784121628
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Glycerin (different manufacturers) — 4 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Apr 27, 2026 — Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision. (Oasis Medical, Inc.) · FDA recall D-0525-2026
Class II · Apr 20, 2026 — Lack of Assurance of Sterility (SCOPE HEALTH) · FDA recall D-0499-2026
Class II · Mar 25, 2026 — Lack of Assurance of Sterility (Preferred Pharmaceuticals, Inc.) · FDA recall D-0443-2026
Class II · Mar 3, 2026 — Lack of Assurance of Sterility (K.C. Pharmaceuticals, Inc) · FDA recall D-0411-2026
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) 67777-161-11
Product NDC 67777-161
11-digit billing NDC 67777016111
NCPDP billing unit EA — each (per item)
RxCUI 1114098
UNII PDC6A3C0OX
UPC 0616784121628
Application # M022
SPL Set ID 99fc00ea-9d55-0380-e053-2995a90a2c0b
Established class (EPC) Non-Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production
Chemical class Allergens; Glycerol
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-12-18
Route ORAL
Dosage form SWAB
Substance GLYCERIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 077319
GCN 43295
HICL code 002184
Ingredient (HICL) Glycerin
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3A
Therapeutic class — specific (HIC3) Protectives
AHFS code 94:00.00.00
AHFS class Devices
FDB label name LEMON GLYCERIN SWABSTICK
FDB brand name Lemon Glycerin
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 077319
  • GCN: 43295
  • HICL (First Databank): 002184
  • AHFS class code: 94:00.00.00
  • RxCUI (RxNorm): 1114098
Why two NDCs? The FDA registers this code as 67777-161-11 — 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 → 67777-0161-11. 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 Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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

Label name LEMON GLYCERIN SWABSTICK Ingredient Glycerin
🧪 What is this product?

This is an over-the-counter oral swab product that contains glycerin as its active ingredient. Glycerin is commonly used in oral swabs as a moistening and soothing agent for dry mouth or irritated oral tissues. The lemon flavoring provides taste. This product is marketed under the FDA's OTC monograph rules for its category rather than through an individual drug application.

Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 25 applicators
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
67777-0161-10 67777-161-10 Main listing 250 BOX in 1 CASE / 25 APPLICATOR in 1 BOX / .3 g in 1 APPLICATOR 2019-12-18 — Active
67777-0161-11 You're viewing this 25 APPLICATOR in 1 BOX / .3 g in 1 APPLICATOR 2019-12-18 — Active

Pack size FAQ

What quantity is in this package?
This package contains 25 applicators — 25 applicator in 1 box / .3 g in 1 applicator.
What NDC number is used to bill for this package of Lemon Glycerin .3 g/4g Swab?
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
Lemon .3 g/4g 55681-0750-00 TwinMed 25 packets — — FDA listed —
Lemon Glycerine Swabsticks 7.5 g/100g 60913-0061-01 PHOENIX 50 pouches — — FDA listed —
Lemon Glycerin .3 g/4gthis 67777-0161-11 Dynarex 25 applicators — — FDA listed —
Lemon 7.5 mg/100mg 68786-0160-01 Sion 50 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

🏛️
2019
On the market since
Dec 2019
📍
2026
Currently FDA-listed
7 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

FlavorLemon
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 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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.

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

The official label also statesCitric Acid, Lemon Flavor, Sodium Benzoate, 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

LabelerDynarex Corporation
FDA applicationM022 (OTC MONOGRAPH DRUG)
Labeler code67777
First marketedDec 2019
Product typeHuman Otc Drug
Portfolio60 products on file

More NDCs from Dynarex Corporation labeler code 67777

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 📄 Do Not Use 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 18 words ▾

Use(s) For temporary relief of minor discomfort and protection of irritated areas in sore mouth and sore throat

⏱️ Dosage and Administration 50 words ▾

Directions Adults and children 12 years of age and older: Tear open the packet and remove the swabstick. Swab around the mouth and discard. Use as needed or as directed by a dentist or doctor. Childern under 12 years of age should be supervised in the use of this product.

⚠️ Warnings 103 words ▾

Warnings For Oral Use Only. Do not get in eyes. Do not use • If you are allergic to any of the ingredients • On children under 2 years of age unless directed by a doctor or dentist Stop use and ask a doctor if • Sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting • Sore mouth symptoms do not imrpove in 7 days Keep out of reach of children If swallowed, or in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

🧪 Active Ingredient 4 words ▾

Active Ingredient Glycerin 7.5%

🧪 Inactive Ingredients 9 words ▾

Inactive ingredients Citric Acid, Lemon Flavor, Sodium Benzoate, Water

🎯 Purpose 3 words ▾

Purpose Oral Demulcent.

📄 Do Not Use 28 words ▾

Do not use • If you are allergic to any of the ingredients • On children under 2 years of age unless directed by a doctor or dentist

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if • Sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting • Sore mouth symptoms do not imrpove in 7 days

📄 Keep Out of Reach of Children 25 words ▾

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

📄 Other Information 13 words ▾

Other information • Store at room temperature 15º-30ºC (59º-86ºF) • Avoid excessive heat

📄 Questions or Comments 9 words ▾

Questions? 1-888-DYNAREX Monday - Friday, 9AM - 5PM EST

📄 Package Label / Principal Display Panel 7 words ▾

Label 1216 Lemon-Glycerin Swabstick 1216 BX MASTER

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 Dynarex Corporation. 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 applicators (67777-0161-10). 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?
Dynarex 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.
← 67777-0147-30 · Dynarex 67777-0175-11 · Dynarex →
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.