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Gel Cooling Pain Relief Menthol 40 mg/mL Gel, 74 mL — NDC 11344-0894-18 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Gel Cooling Pain Relief Menthol 40 mg/mL Gel, 74 mL — NDC 11344-894-18 (Billing 11344-0894-18)

by Nice-Pak Products, LLC · 74 mL in 1 BOTTLE, WITH APPLICATOR

This is a package of 74 mL of Gel Cooling Pain Relief Menthol 40 mg/mL Gel from Nice-Pak Products, LLC, marketed since Jan 2021 and currently FDA-listed. It is this product's only package size.

NDC 11344-0894-18
🏷️ FDA NDC (as labeled) 11344-894-18 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
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) 11344-894-18
Product NDC 11344-894
11-digit billing NDC 11344089418
Application # M017
SPL Set ID 696f678d-8f76-4087-a52e-efe3c9f814d0
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-01-13
Route TOPICAL
Dosage form GEL
Substance MENTHOL
Why two NDCs? The FDA registers this code as 11344-894-18 — 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 → 11344-0894-18. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 Read our full Menthol guide →

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.
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
11344-0894-18 You're viewing this Main listing 74 mL in 1 BOTTLE, WITH APPLICATOR 2021-01-13 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Leader Cooling Pain Relief Topical Analgesic 40 mg/mL 70000-0618-01 Cardinal 89 ml $0.052 — Availability likely —
Leader Roll-On Cooling Pain Relief Topical Analgesic 40 mg/mL 70000-0617-01 Cardinal 74 ml $0.059 — Availability likely —
Gel Cooling Pain Relief 40 mg/mLthis 11344-0894-18 Nice-Pak 74 ml — — FDA listed —
Target Up and Up Pain Relief Menthol Topical Analgesic Roll-On 40 mg/mL 11673-0261-03 TARGET 89 ml — — FDA listed —
Gel Cooling Pain Relief 40 mg/mL 30142-0043-18 The 74 ml — — FDA listed —
TopCare Pain Relieving Roll-On Topical Analgesic 40 mg/mL 36800-0290-01 Topco 74 ml — — FDA listed —
4% Menthol PAIN RELIEF 4 g/100mL 43473-0095-25 Nantong 74 ml — — FDA listed —
4% Menthol Cold Therapy 4 g/100g 43473-0098-15 Nantong 1 tube — — FDA listed —
Dragon with Arnical Pain Relief 4 g/100g 50066-0621-56 Genomma 1 tube — — FDA listed —
Biofreeze Roll-On 40 mg/mL 50090-6358-00 A-S 74 ml — — FDA listed —
Biofreeze Colorless 40 mg/mL 50090-6361-00 A-S 89 ml — — FDA listed —
GoodSense Cooling Pain Relief 4 g/100mL 50804-0297-03 Geiss, 1 tube — — FDA listed —
CVS Pain Relief Lavender Scent 4 g/100mL 51316-0118-02 CVS 74 ml — — FDA listed —
CVS Pain Relief 4 g/100mL 51316-0161-02 CVS 74 ml — — FDA listed —
CVS Pain Relief 40 mg/mL 51316-0933-03 CVS 89 ml — — FDA listed —
CVS Pain Relief 4 g/100g 51316-0997-04 CVS 85 g — — FDA listed —
4% Menthol PAIN RELIEF 4 g/100mL 52000-0439-25 Universal 74 ml — — FDA listed —
4% Menthol Cold Therapy 4 g/100g 52000-0442-15 Universal 1 tube — — FDA listed —
DG Health Cold Zone Pain Relieving Topical Analgesic 40 mg/mL 55910-0884-01 Dolgencorp 59 ml — — FDA listed —
Biofreeze 40 mg/mL 59316-0102-10 Reckitt 5 ml — — FDA listed —
Biofreeze Colorless 40 mg/mL 59316-0103-12 Reckitt 89 ml — — FDA listed —
Biofreeze Overnight Gel 40 mg/mL 59316-0121-10 Reckitt 89 ml — — FDA listed —
Biofreeze Roll-On 40 mg/mL 59316-0205-10 Reckitt 89 ml — — FDA listed —
Biofreeze Colorless Roll-On 40 mg/mL 59316-0206-10 Reckitt 1 bottle — — FDA listed —
Biofreeze Overnight Roll-on 40 mg/mL 59316-0207-14 Reckitt 74 ml — — FDA listed —
Biofreeze Roll-On and Overnight Roll-On 59316-0209-14 Reckitt 2 bottles — — FDA listed —
Pain Relieving 4 g/100g 61010-4403-01 Safetec 113.4 g — — FDA listed —
X-Treme Freeze 4 g/100mL 67777-0144-10 Dynarex 100 packets — — FDA listed —
Cold Therapy Roll on .04 g/mL 69168-0483-67 Allegiant 74 ml — — FDA listed —
Pain Relief Gel Roll On 40 g/L 69396-0184-01 Trifecta 1 bottle — — FDA listed —
Tommie Copper Cooling Roller Lavender Scent 4 g/100mL 72562-0185-03 Tommie 89 ml — — FDA listed —
DCH Cooling Pain Relief 4 g/100mL 72839-0297-03 Derma 89 ml — — FDA listed —
PAIN RELIEF Gel-Tube .04 g/mL 73557-0323-30 Shanghai 89 ml — — FDA listed —
PAIN RELIEF Gel-Roll On .04 g/mL 73557-0333-25 Shanghai 74 ml — — FDA listed —
BonicaEaseX Colorless Roll-On Menthol Pain Relieving 40 mg/mL 75568-0041-00 Planet 3 bottles — — FDA listed —
BonicaEaseX Menthol Pain Relieving 40 mg/mL 75568-0043-00 Planet 3 tubes — — FDA listed —
Gel Cooling Pain Relief 40 mg/mL 76162-0894-21 Topco 89 ml — — FDA listed —
meijer Cold Therapy Pain Relieving analgesic 40 mg/mL 79481-0087-01 Meijer 89 ml — — FDA listed —
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic 40 mg/mL 79481-0088-01 Meijer 74 ml — — FDA listed —
Equate Cold Therapy Pain Relieving Analgesic 40 mg/mL 79903-0021-01 Wal-Mart 89 ml — — FDA listed —
Equate Cold Therapy Pain Relieving Roll-on Analgesic 40 mg/mL 79903-0022-01 Wal-Mart 74 ml — — FDA listed —
Thera Plus Cold Therapy Pain Relieving Menthol 40 mg/mL 80684-0101-00 Fourstar 74 ml — — FDA listed —
Sync Ice 4 g 82944-0300-74 iON 1 bottle — — FDA listed —
DIRT Pain Relieving Gel 40 mg/mL 83067-0363-00 PURIVITAE, 88 ml — — FDA listed —
DIRT Pain Relieving Gel 40 mg/mL 83067-0463-00 PURIVITAE, 88 ml — — FDA listed —
Quality Choice Cold Therapy Gel 40 mg/mL 83324-0007-04 Chain 118.2 ml — — FDA listed —
Auvon 4% Menthol Pain Relief Gel .04 mg/mL 83391-0007-01 SHENZHEN 89 ml — — FDA listed —
Menthol Pain Relief Gel-Tube .04 g/mL 83602-0323-30 Guangzhou 89 ml — — FDA listed —
Menthol Pain Relief Gel-Roll On .04 g/mL 83602-0333-25 Guangzhou 74 ml — — FDA listed —
Pain Relief Gel-Tube .04 g/mL 84008-0003-02 Bullet 1 bottle — — FDA listed —
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-On 4 g/100mL 84165-0008-01 Guangzhou 1 bottle — — FDA listed —
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-On 4 g/100mL 84165-0009-01 Guangzhou 1 bottle — — FDA listed —
HEEL PAIN Relief Gel Roll-On .04 g/mL 84165-0011-01 Guangzhou 1 bottle — — FDA listed —
PLANTAR FASCIITIS Relief Gel Roll-On 4 g/100mL 84165-0012-01 Guangzhou 1 bottle — — FDA listed —
PRO COLD HOT Pain Relief Gel Roll-On (Plantar Fasciitis) 4 g/100mL 84165-0013-01 Guangzhou 1 bottle — — FDA listed —
AVCOO Pain Relief 4 g/100mL 84992-0003-01 ADP 89 ml — — FDA listed —
Dr. Carrasco Pain Relief 40 mg/mL 69921-0024-01 Carrasco 89 ml — — FDA listed —
Nerve Reverse Pain Relief 40 mg/mL 73067-0870-04 Pogue 118 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

🏛️
2021
On the market since
Jan 2021
📍
2026
Currently FDA-listed
5 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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 597E9BI3Z3
    Arctium lappa root is a plant-derived ingredient used in some traditional and herbal preparations. In formulations, it may serve as a natural extract or botanical agent to support product stability or flavor.
  • UNII OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII N20HL7Q941
    Camphor is a waxy, aromatic substance derived from camphor tree wood or made synthetically. In medicines, it typically serves as a preservative, flavoring agent, or mild skin irritant in topical products.
  • UNII 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • UNII FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance 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 R9XLF1R1WM
    Frankincense is a natural resin from the Boswellia tree. It's used in medicines as a binder or thickener to help hold ingredients together and improve the product's consistency and texture.
  • 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 W2ZU1RY8B0
    A plant extract from green tea leaves. It's used as an antioxidant ingredient to help preserve the medicine and maintain its stability during storage.
  • UNII 1Q953B4O4F
    Ilex paraguariensis leaf, commonly known as yerba mate, is a plant extract used in medicines as a flavoring agent and to add botanical content. It may also contribute mild preservative properties to the formulation.
  • UNII ND2M416302
    Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII O84B5194RL
    A plant extract from juniper berries used as a flavoring agent to improve the taste of medicines. It may also contribute mild antimicrobial properties to support product stability.
  • UNII YF70189L0N
    Melissa officinalis, commonly known as lemon balm, is a plant extract used as a flavoring and aromatic ingredient in medicines. It adds a mild lemon scent and taste to improve palatability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

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

The official label also statesAloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

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

LabelerNice-Pak Products, LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11344
First marketedJan 2021
Product typeHuman Otc Drug
Portfolio45 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.

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 🤒 Adverse Reactions 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 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 21 words ▾

Uses for temporary relief from minor aches and pains of muscles & joints associated with simple backache arthritis strains bruises sprains

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a doctor

⚠️ Warnings 12 words ▾

Warnings For external use only Flammable, keep away from fire or flame.

🤒 Adverse Reactions 13 words ▾

Adverse reaction Distributed by: Consumer Product Partners, LLC St. Louis, MO 63114 1-888-593-0593

📦 Storage and Handling 12 words ▾

Other information store in a cool dry place with lid closed tightly

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 4%

🧪 Inactive Ingredients 59 words ▾

Inactive ingredients Aloe barbadensis leaf juice, Arctium lappa root extract, Arnica montana flower extract, blue 1, Boswellia carterii resin extract, Calendula officinalis flower extract, Camellia sinensis leaf extract, camphor, carbomer, Chamomilla recutita (matricaria) flower extract, glycerin, llex paraguariensis leaf extract, isopropyl alcohol, isopropyl myristate, Juniperus communis fruit extract, Melissa officinalis extract, silica, sodium hydroxide, tocopheryl acetate, water, yellow 5

🎯 Purpose 3 words ▾

Purpose External analgesic

📄 When Using This Product 21 words ▾

When using this product avoid contact with the eyes do not apply to wounds or damaged skin do not bandage tightly

📄 Stop Use and Ask a Doctor If 28 words ▾

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

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

📄 Package Label / Principal Display Panel 45 words ▾

Principal display panel swan ® ROLL-ON COOLING PAIN RELIEF PAIN RELIEVING GEL soothing menthol For arthritis, sore muscles, joints and back pain Diminishing scent Compare to Biofreeze ® Cool the Pain ® Colorless Roll-On Menthol Pain Relieveing Gel*

2.5 FL OZ (74 mL) image description

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 Gel Cooling Pain Relief (this brand).

Top reported reactions

Dyspnoea85
Fatigue84
Pain81
Pruritus78
Dizziness67
Headache67
Cough65

Age at onset

Infant1
Child1
Adolescent1
Adult95
Elderly90

Reporter sex

989 reports
Male · 38%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization333
Death125
Life-threatening45
Disabling26
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 109 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 Nice-Pak Products, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Nice-Pak Products, 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.
← 11344-0880-10 · Nice-Pak 11344-0900-77 · Nice-Pak →
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.