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MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g Patch — NDC 55301-0912-05 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g Patch — NDC 55301-912-05 (Billing 55301-0912-05)

by ARMY AND AIR FORCE EXCHANGE SERVICE · 5 PATCH in 1 POUCH / 8 g in 1 PATCH

This is a package of MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100g Patch from ARMY AND AIR FORCE EXCHANGE SERVICE, marketed since Jun 2019 and currently FDA-listed. It is this product's only package size.

NDC 55301-0912-05
🏷️ FDA NDC (as labeled) 55301-912-05 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 Sep 3, 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 55301-912-05 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55301 labeler · 912 product · 05 package
Package marketed since
Jun 1, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0614299793019
FDA record last changed
Sep 3, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 55301-912-05
Product NDC 55301-912
11-digit billing NDC 55301091205
RxCUI 1249758
UNII 98PI200987, L7T10EIP3A
UPC 0614299793019
Application # M017
SPL Set ID 60f72061-d264-424e-b396-5a609076d352
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 2019-06-01
Route TOPICAL
Dosage form PATCH
Substance LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Quick answers
  • RxCUI (RxNorm): 1249758
Why two NDCs? The FDA registers this code as 55301-912-05 — 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 → 55301-0912-05. 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 Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
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 patch containing lidocaine and menthol, marketed as an over-the-counter monograph drug. Lidocaine is a local anesthetic commonly used to numb skin and relieve pain on contact. Menthol is often used in topical products for its cooling sensation and mild counterirritant effects. The patch form allows the active ingredients to be applied directly to the affected area of skin.

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 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
55301-0912-05 You're viewing this Main listing 5 PATCH in 1 POUCH / 8 g in 1 PATCH 2019-06-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lidocaine Menthol Pain Relief 4 g/100g; 1 g/100g 46122-0574-21 Amerisource 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 70000-0558-01 Cardinal 5 patches $0.952 — Availability likely —
Cold and Heat Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 00363-0914-05 Walgreen 5 patches — — FDA listed —
Walgreens Cool N Heat Patch 10 mg/g; 40 mg/g 00363-6670-05 Walgreen 5 patches — — FDA listed —
Walgreens Kinesiology Pain Relief 4 mg/100mg; 1 mg/100mg 00363-9657-00 Walgreen 20 applicators — — FDA listed —
Maximum Strenght Lidocaine plus Menthol Pain Relief Patch 1 g/100g; 4 g/100g 11822-6514-01 Rite 5 patches — — FDA listed —
Albertson Lidocaine, Menthol Pain Relief Medicated Patch 4 g/100g; 1 g/100g 21130-0961-05 Safeway 5 g — — FDA listed —
Icy Hot with Lidocaine 240 mg/1; 60 mg 41167-1720-01 Chattem, 5 patches — — FDA listed —
Maximun Strength Lidocaine Patch Plus Menthol 4 g/100g; 1 g/100g 41250-0841-05 Meijer 5 patches — — FDA listed —
CVS Cold and Hot Pain Relief 10 mg/g; 40 mg/g 51316-0274-05 CVS 5 patches — — FDA listed —
Lidospot patch .01 g/g; .04 g/g 51452-0172-05 Fabrication 5 patches — — FDA listed —
Point Relief LidoSpot with Menthol 4 g/100g; 1 g/100g 51452-0912-05 Fabrication 5 patches — — FDA listed —
MAXIMUM STRENGTH Lidocaine Plus Menthol 4 g/100g; 1 g/100gthis 55301-0912-05 ARMY 5 patches — — FDA listed —
Biofreeze Ultraflex Plus .04 g/g; .01 g/g 59316-0898-04 Reckitt 4 patches — — FDA listed —
CVS Health Lidocaine Pain Relief Plus Menthol 240 mg/1; 60 mg 66902-0220-05 Natural 5 patches — — FDA listed —
Pure-Aid 240 mg/1; 60 mg 67510-0284-01 Kareway 1 patch — — FDA listed —
Soundbody 40 mg/1; 10 mg 67510-0636-01 Kareway 1 patch — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 68788-8879-01 Preferred 15 mg — — FDA listed —
Lidocaine Pain Relief Patch 1 g/100g; 4 g/100g 69159-0920-05 Foshan 5 patches — — FDA listed —
HealthWise Lidocaine Plus Menthol Patch 4 g/100g; 1 g/100g 71101-0062-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol 4 g/100g; 1 g/100g 71101-0082-15 Veridian 15 g — — FDA listed —
TheraCare 2X Medicated Pain Relief 1 g/100g; 4 g/100g 71101-0127-01 Veridian 5 patches — — FDA listed —
TheraCare Pain Relief Medicated 4 g/100g; 1 g/100g 71101-0912-05 Veridian 5 g — — FDA listed —
HealthWise Lidocaine and Menthol Pain Relief 4 g/100g; 1 g/100g 71101-0914-05 Veridian 5 g — — FDA listed —
Lidozen 40 mg/g; 10 mg/g 71205-0348-05 Proficient 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71205-0745-05 Proficient 5 patches — — FDA listed —
Dr Sabharwals 224 mg/1; 56 mg 71318-0115-15 Dr. 15 patches — — FDA listed —
AsperFlex MAX 240 mg/1; 60 mg 71399-4453-05 Akron 5 patches — — FDA listed —
Lidozen Patch 40 mg/g; 10 mg/g 71574-0905-05 Village 5 patches — — FDA listed —
Hot and Cold Lidocaine with Menthol Patch Pain Relief 240 mg/1; 60 mg 71811-0002-05 InterMed 500 patches — — FDA listed —
Lidothol Patch 1 mg/100mg; 4 mg/100mg 72189-0553-15 Direct_Rx 1 patch — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0172-05 Shanghai 5 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0174-20 Shanghai 20 patches — — FDA listed —
Pain Relief .01 g/g; .04 g/g 73557-0175-20 Shanghai 20 patches — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 73557-0176-18 Shanghai 18 patches — — FDA listed —
Careland Lidocaine 4 plus menthol pain relieving gel-patches with border for knee 40 mg/g; 10 mg/g 75568-0013-01 Planet 4.56 g — — FDA listed —
Careland Lidocaine 4 Plus Menthol Pain Relieving Gel Patches for back, neck shoulders knees and elbows with border 40 mg/g; 10 mg/g 75568-0014-01 Planet 9.1 g — — FDA listed —
Careland Plantar Fasciitis Hydrogel Pain Patches 40 mg/g; 10 mg/g 75568-0017-01 Planet 8 pouches — — FDA listed —
Careland Hydrogel Pain Relief Patches 40 mg/g; 10 mg/g 75568-0022-01 Planet 8 patches — — FDA listed —
TopCare Pain Relief Patch 4 g/100g; 1 g/100g 76162-0007-05 Topco 5 pouches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 76420-0581-15 Asclemed 15 patches — — FDA listed —
Equate Lidocaine and Menthol Paraben Free 1 g/100g; 4 g/100g 79903-0030-05 Walmart 5 pouches — — FDA listed —
Equate Lidocaine Cool and Heat 1 g/100g; 4 g/100g 79903-0038-05 Walmart 5 pouches — — FDA listed —
Lidothol 1 mg/100mg; 4 mg/100mg 80425-0385-01 Advanced 15 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 80425-0506-01 Advanced 15 mg — — FDA listed —
Lidocaine and Menthol .04 g/g; .01 g/g 80425-0560-01 Advanced 30 patches — — FDA listed —
LidoPro .04 g/g; .01 g/g 80425-0582-01 Advanced 30 patches — — FDA listed —
LidoReal Patch 4 mg/1; 1 mg 81877-0725-15 FORREAL 15 patches — — FDA listed —
Zylotrol Maximum Pain .03 g/3g; .12 g/3g 81902-0104-15 Whitestone 15 patches — — FDA listed —
Lidosync 4 g/1; 1 g 82944-0104-10 Ion 10 patches — — FDA listed —
Pain Relief Gel-Patch .12 g/12g; .48 g/12g 83016-0171-07 R 7 packets — — FDA listed —
AUVON Lidocaine Menthol Pain Relief Patch 100 mg/1; 400 mg 83391-0008-01 SHENZHEN 1 patch — — FDA listed —
Collajoint Lidocaine Pain Relief Gel Patch 1 g/1001; 4 g/1001 83559-0012-01 Henan 12 patches — — FDA listed —
Rapid Relief 1 g/100g; 4 g/100g 83569-0014-01 RAPID 100 g — — FDA listed —
Rapid Relief 4 g/100g; 1 g/100g 83569-0016-06 RAPID 1 pouch — — FDA listed —
Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0172-15 Guangzhou 15 patches — — FDA listed —
Foot Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0174-15 Guangzhou 15 patches — — FDA listed —
Lidocaine Pain Relief Gel-Patch .01 g/g; .04 g/g 83602-0175-11 Guangzhou 11 patches — — FDA listed —
Knee Pain Relief Gel-Patch .04 g/g; .01 g/g 83602-0178-12 Guangzhou 12 patches — — FDA listed —
LidoPro Patch (Lidocaine 4%, Menthol 1%) 84 mg/8400mg; 336 mg/8400mg 83881-0402-05 Clinic 5 mg — — FDA listed —
LidoPro .04 g/g; .01 g/g 83881-0403-01 Clinic 1 patch — — FDA listed —
Lidothol 4 mg/100mg; 1 mg/100mg 83881-0441-15 Clinic 15 patches — — Discontinued —
Plantar Fasciitis Pain Relief Gel-Patch 1 g/100g; 4 g/100g 84165-0007-01 Guangzhou 6 g — — FDA listed —
Chinese Red Tiger Lidocaine Patches .04 g/g; .01 g/g 84165-0010-01 Guangzhou 12 g — — FDA listed —
PAIN RELIEF Gel-Patch .01 g/g; .04 g/g 84165-0104-01 Guangzhou 12 g — — FDA listed —
Perform Leo Extensive Pain Relief 4 g/100g; 1 g/100g 84410-0001-01 PERFORM 5 patches — — FDA listed —
Lidocaine .4 g/10g; .1 g/10g 84722-3041-00 Vive 5 g — — FDA listed —
Lidocaine .1 g/10g; .4 g/10g 84722-3072-00 Vive 5 g — — FDA listed —
4% lidocaine plus 1% menthol Pain Relief Patch 1 g/100g; 4 g/100g 85323-0003-00 Xuzhou 5 patches — — FDA listed —
4% Lidocaine Patches 4 g/100g; 1 g/100g 85593-0010-01 Guangzhou 15 patches — — Discontinued —
NeuroCool Patches 4 mg/100mg; 1 mg/100mg 85622-0500-15 Blue 15 pouches — — FDA listed —
Plantar Pain Relief Patch .01 g/g; .04 g/g 87518-0174-15 Guangzhou 15 patches — — 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
Jun 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
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.

Manufacturer & labeler

LabelerARMY AND AIR FORCE EXCHANGE SERVICE
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55301
First marketedJun 2019
Product typeHuman Otc Drug
Portfolio47 products on file

More NDCs from ARMY AND AIR FORCE EXCHANGE SERVICE labeler code 55301

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

USES Temporary relief of minor pain

⏱️ Dosage and Administration 53 words ▾

DIRECTIONS Adults and children 12 years of age and over: Clean and dry affected area. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Discard after single use. Children under 12 years of age: consult a physician.

⚠️ Warnings ~1 min read ▾

WARNINGS For External use only. Use only as directed. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. ■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened. If pregnant or breast feeding Contact a physician prior to use. WHEN USING: ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets.

Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and consult a doctor if ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

📦 Storage and Handling 14 words ▾

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

🧪 Active Ingredient 8 words ▾

Lidocaine 4% Topical Anesthetic Menthol 1% Topical Anesthetic

🧪 Inactive Ingredients 27 words ▾

INACTIVE INGREDIENTS carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, ethylhexylglycerin, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

🎯 Purpose 2 words ▾

Topical Anesthetic

📄 Do Not Use 50 words ▾

■ More than one patch on your body at a time ■ On cut, irritated or swollen skin ■ On puncture wounds ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients ■ If pouch is damaged or opened.

📄 When Using This Product 99 words ▾

WHEN USING: ■ Use only as directed ■ Read and follow all directions and warnings on this carton ■ Do not allow contact with the eyes ■ Do not use at the same time as other topical analgesics ■ Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

📄 Stop Use and Ask a Doctor If 53 words ▾

Stop use and consult a doctor if ■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast feeding Contact a physician prior to use.

📄 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 2 words ▾

Label box

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 Lidocaine, Menthol — the ingredient across all brands.

Top reported reactions

Pain3,217
Fatigue3,056
Nausea3,046
Headache2,815
Dyspnoea2,181
Pneumonia2,007
Diarrhoea1,981

Age at onset

Neonate144
Infant62
Child366
Adolescent259
Adult4,987
Elderly3,158

Reporter sex

49,320 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization17,575
Life-threatening4,202
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 5,427 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ARMY AND AIR FORCE EXCHANGE SERVICE. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
ARMY AND AIR FORCE EXCHANGE SERVICE 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.
← 55301-0904-01 · Army 55301-0915-55 · Army →
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.