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LidoStat LIDOCAINE HCL 40 mg/g Cream — NDC 44577-0704-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

LidoStat LIDOCAINE HCL 40 mg/g Cream — NDC 44577-704-02 (Billing 44577-0704-02)

by Clinical Therapeutic Solutions · 1 TUBE in 1 CARTON / 56 g in 1 TUBE

This is a package of LidoStat LIDOCAINE HCL 40 mg/g Cream from Clinical Therapeutic Solutions, marketed since Jun 2013 and currently FDA-listed. It is this product's only package size.

NDC 44577-0704-02
🏷️ FDA NDC (as labeled) 44577-704-02 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 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 44577-704-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
44577 labeler · 704 product · 02 package
Package marketed since
Feb 7, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 4457770402 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44577-704-02
Product NDC 44577-704
11-digit billing NDC 44577070402
RxCUI 1010895, 1427002
UNII V13007Z41A
Application # M017
SPL Set ID 1825885b-9141-4515-bb69-a1c4a39fb10d
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 2013-06-19
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1010895
Why two NDCs? The FDA registers this code as 44577-704-02 — 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 → 44577-0704-02. 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

📗 Our plain-language guide HelloPharmacist
  • Lidocaine numbs the area where it is used. Clinicians inject it for procedures. Skin products are used for pain, itching, minor burns, insect bites, hemorrhoid discomfort, and in s...
  • Clean and dry the skin first, then apply as your product’s directions say. Wash your hands afterward. Don’t exceed the number of uses on the label. Ask a doctor before using a prod...
  • No. Heat can increase how much lidocaine your body absorbs. Don’t bandage tightly either. Also avoid using other topical pain products at the same time.
  • Can I use a heating pad with a lidocaine patch?
📖 Read our full Lidocaine 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
44577-0704-02 You're viewing this Main listing 1 TUBE in 1 CARTON / 56 g in 1 TUBE 2017-02-07 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
GNP Lidocaine Maximum Strength 4 g/100g 46122-0614-10 AMERISOURCE 1 bottle $0.052 — Availability likely —
Leader 4 g/100g 70000-0098-01 Cardinal 1 bottle $0.052 — Availability likely —
Lidocaine HCL 4 g/100g 87137-0101-07 Matthias 1 bottle $0.052 — Availability likely —
Pain and Itch Relief 4% Lidocaine .04 g/40g 00363-3001-24 Walgreens 1 tube — — FDA listed —
Walgreens Pain Relieving Cream 4 g/100g 00363-3037-02 Walgreens 76.5 g — — FDA listed —
Mentholatum Lidocaine Heat 40 mg/mL 10742-8386-01 The 1 bottle — — FDA listed —
Signature Care Lidocaine Cream 40 mg/g 21130-0544-27 Better 1 bottle — — FDA listed —
Kroger Analgesic Analgesic 40 mg/g 30142-0260-01 THE 1 bottle — — FDA listed —
TopCare Pain Relieving Analgesic 40 mg/g 36800-0470-01 Topco 1 bottle — — FDA listed —
Gold Bond Medicated Pain and Itch Relief 4 g/100g 41167-0529-00 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine with Rosemary and Mint 4 g/100g 41167-0565-00 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine with Eucalyptus Essential Oil 4 g/100g 41167-0566-00 Chattem, 1 tube — — FDA listed —
Aspercreme with Lidocaine Pain Relieving Creme 4 g/100g 41167-0582-01 Chattem, 1 bottle — — FDA listed —
Aspercreme with Lidocaine Foot Pain Creme 4 g/100g 41167-0586-02 Chattem, 1 bottle — — FDA listed —
Aspercreme with Lidocaine Pain Relieving Creme 4 g/100g 41167-0587-07 Chattem, 1 bottle — — FDA listed —
Aspercreme Lidocaine Foot (Diabetic) 4 g/100g 41167-0597-00 Chattem, 1 bottle — — FDA listed —
LidoStat 40 mg/gthis 44577-0704-02 Clinical 1 tube — — FDA listed —
Equate Pain Relief Cream 4 mg/100mL 49035-0634-97 Walmart, 74 ml — — FDA listed —
Equate Pain Relieving Cream Lidocaine 40 mg/g 49035-0860-01 Wal-Mart 1 bottle — — FDA listed —
CVS Lidocaine Pain Relief Cream 40 mg/g 51316-0379-43 CVS 1 bottle — — FDA listed —
Launch Medical 4 g/100mL 54723-0018-01 Sambria 30 ml — — FDA listed —
BeardedMoney 4 g/100g 54723-0032-01 Sambria 15 g — — FDA listed —
NeuroMed 7 Topical Pain Relief 4 g/100g 54723-0175-22 Sambria 1 tube — — FDA listed —
DG Health Pain Relieving 40 mg/g 55910-0759-01 DOLGENCORP, 1 bottle — — FDA listed —
T-Relief Lidocaine HCL 4% 3.4 g/85g 62795-6050-07 Medinatura 85 g — — FDA listed —
QC Lidocaine Maximum Strength 4 g/100g 63868-0956-01 Chain 1 bottle — — FDA listed —
Pain Itch Relief 4 g/100g 69396-0120-17 Trifecta 1 bottle — — FDA listed —
Lidocaine 4 Percent 4 g/100g 69420-6262-01 SA3, 120 g — — FDA listed —
CVS Health Lidocaine Cream 40 mg/g 69842-0814-77 CVS 1 bottle — — FDA listed —
CVS Lidocaine Maximum Strength 4 g/100g 69842-0921-49 CVS 1 bottle — — FDA listed —
CVS Health Lidocaine Pain Relief 40 mg/g 69842-0980-01 CVS 1 bottle — — FDA listed —
BENGAY Tropical Jasmine 40 mg/g 69968-0614-03 Kenvue 1 tube — — FDA listed —
NumbR-X 4 g/100g 70171-0001-01 Prodigy 1 jar — — FDA listed —
Dr Lido 4 g/100g 70171-0002-01 Prodigy 1 jar — — FDA listed —
Inked Inspired 4 g/100g 70171-0003-01 Prodigy 1 jar — — FDA listed —
Dr Tatty Numbing 4 g/100g 70171-0020-01 Prodigy 1 jar — — FDA listed —
TattooGirl Numbing 4 g/100g 70171-0021-01 Prodigy 1 tube — — FDA listed —
InkKulture Numbing 4 g/100g 70171-0022-01 Prodigy 1 tube — — FDA listed —
Inkorporated Numbing 4 g/100g 70171-0028-01 Prodigy 1 jar — — FDA listed —
Ink Scribd Numbing 4 g/100g 70171-0029-01 Prodigy 1 jar — — FDA listed —
LidoPlus Pain Relief 40 mg/mL 70372-0723-01 Centura 1 tube — — FDA listed —
TheraCare Pain Relieving Lidocaine Cream 4 g/100g 71101-0056-01 Veridian 1 bottle — — FDA listed —
TheraCare Pain Relieving Lidocaine Cream 4 g/100g 71101-0057-01 Veridian 1 bottle — — FDA listed —
HealthWise 4% Lidocaine Cream 2.7 oz 4 g/100g 71101-0102-01 Veridian 1 bottle — — FDA listed —
HealthWise Pain Relief Lidocaine 4 g/100g 71101-0107-47 Veridian 1 bottle — — FDA listed —
HealthWise 4% Lidocaine Cream 4 g/100g 71101-0919-27 Veridian 1 bottle — — FDA listed —
TheraCare 4% Lidocaine Cream 4 g/100g 71101-0930-01 Veridian 1 bottle — — FDA listed —
HealthWise Pain Relief Cream with Lidocaine 4 g/100g 71101-0932-01 Veridian 1 bottle — — FDA listed —
Lidocaine HCl 4 Percent 4 g/100g 71436-0026-01 ARI 120 g — — FDA listed —
Lidozall Plus 4 g/100g 72835-0114-15 V2 15 packets — — FDA listed —
Lidozall Pro 4 g/100g 72835-0445-05 V2 5 packets — — FDA listed —
DCH Pain Relief 4 g/100g 72839-0361-02 Derma 76.5 g — — FDA listed —
SUGAR BRANDS Rescue Pain Relief and Recovery 40 mg/mL 73313-0075-04 Sugar 118 ml — — FDA listed —
Lidocaine HCI 40 mg/g 73352-0204-60 Trifluent 30 g — — FDA listed —
LidoGuard 4 g/100g 73492-0272-30 ALAINA 1 tube — — FDA listed —
TopCare Pain Relieving Cream 40 mg/g 76162-0291-02 Topco 1 bottle — — FDA listed —
Sting Master 40 mg/g 80324-0078-00 Les 1 jar — — FDA listed —
Lidocaine Pain Relief Roll-On 4 g/100mL 82645-0013-97 Pharma 1 bottle — — FDA listed —
Westlake Lidocaine 4 g/100g 82895-0717-50 Westlake 1 bottle — — FDA listed —
Westlake Outdoor Pain and Itch Relieving 40 mg/g 82895-0718-50 WESTLAKE 49 g — — FDA listed —
Lidocore 3.1 g/76.5g 82944-0201-02 iON 1 bottle — — FDA listed —
Gold Bond Maximum Strength Foot Pain Relief 4 g/100g 84714-0427-06 Gold 1 bottle — — FDA listed —
Gold Bond Medicated Pain and Itch Relief 4 g/100g 84714-0529-00 Gold 1 bottle — — FDA listed —
Ikonik Tonik 4 g/100mL 85132-0001-30 IKONIK 1 tube — — FDA listed —
LidoGuard 4 g/100g 85231-0200-30 ViolaCare, 1 tube — — FDA listed —
Alcemiste 4 g/100mL 87087-0001-01 Price 1 jar — — FDA listed —
Tattoo Numbx Numbing Pain Relieving 40 mg/mL 87460-0905-00 Scyberco 1 tube — — FDA listed —
Comfortcaine 40 mg/g 65008-0005-04 QS 1 bottle — — FDA listed —
Derma Numb Pain Relief 40 mg/g 70188-0005-01 A.T.S. 28 g — — FDA listed —
DermaNumb Analgesic 40 mg/g 70188-0006-01 A.T.S. 57 g — — 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

🏛️
2013
On the market since
Jun 2013
📍
2026
Currently FDA-listed
13 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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII 9H4PO4Z4FT
    A sulfur-containing organic compound used as a solvent and penetration enhancer in medicines. It helps dissolve active ingredients and improve their absorption through skin or mucous membranes.
  • UNII 147D247K3P
    Ethylhexylglycerin is a synthetic preservative used to prevent bacteria and mold from growing in medicines and personal care products. It helps keep the product safe and stable throughout its shelf life.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII HIE492ZZ3T
    Phenoxyethanol is a synthetic preservative and antimicrobial agent used to prevent bacterial and fungal growth in medicines and cosmetic products, extending shelf life and maintaining product safety.
  • UNII 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • 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 8W8T17847W
    A nitrogen-containing chemical compound used in pharmaceuticals as a humectant to retain moisture, and sometimes as a keratolytic agent in topical formulations to help soften and remove dead skin cells.
  • 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.

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

The official label also statesAloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.

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

LabelerClinical Therapeutic Solutions
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code44577
First marketedJun 2013
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from Clinical Therapeutic Solutions labeler code 44577

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

Uses: For temporary relief of pain and itching caused by minor skin irritations.

⏱️ Dosage and Administration 34 words ▾

Directions: For adults and children two-years or older, apply externally to the affected area. Do not use more than three to four times per day. Children under 2 years of age: Ask a doctor.

⚠️ Warnings 88 words ▾

Warnings: For external use only. Do not use on children under 2 years of age unless directed by a physician. When using this product avoid contact with eyes Use only as directed.

Do not use in large quantities, particularly over raw surfaces or blistered areas. Stop use and ask a doctor if: symptoms persist for more than seven days, or clear up and occur again within a few days. redness, irritation, swelling, pain or other symptoms increase Keep out of reach of children. If swallowed, consult a physician.

🧪 Active Ingredient 5 words ▾

Active Ingredient Lidocaine HCL 4%

🧪 Inactive Ingredients 32 words ▾

Other Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Bin Vinyl Dimethicone/Dimethicone Copolymer, C13-14 Isoparaffin, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Laureth-7, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Stearic Acid, Triethanolamine, Urea.

🎯 Purpose 3 words ▾

Purpose External Anesthetic

📄 Do Not Use 15 words ▾

Do not use on children under 2 years of age unless directed by a physician.

📄 When Using This Product 25 words ▾

When using this product avoid contact with eyes Use only as directed. Do not use in large quantities, particularly over raw surfaces or blistered areas.

📄 Stop Use and Ask a Doctor If 32 words ▾

Stop use and ask a doctor if: symptoms persist for more than seven days, or clear up and occur again within a few days. redness, irritation, swelling, pain or other symptoms increase

📄 Keep Out of Reach of Children 11 words ▾

Keep out of reach of children. If swallowed, consult a physician.

📄 Questions or Comments 6 words ▾

Question or Comments? Please visit www.BakoCTS.com

📄 Package Label / Principal Display Panel 36 words ▾

LidoStat CREAM Lidocaine HCI 4% In a 20% Urea Vehicle MEDICAL STRENGTH PAIN CREAM PENETRATING FORMULA Dipensed Only by Physicians NET WT. 2.0 oz (56 g) LOT: EXP:

LidoStat CREAM 2oz/56g (44577-704-02) Inner Label Outer Label

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

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

Medicare Part D (outpatient prescription) spending for Lidocaine HCl Viscous (matched by generic name) — the program that covers self-administered drugs. 4 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 Lidocaine HCl Viscous. CMS lists 5 products for this generic; we show the highest-spend one. 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
$2.02M
Claims incl. refills
110.4K
Beneficiaries
87.1K
Spend / beneficiary
$23.19
Spend / claim
$18.30
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.

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 Clinical Therapeutic Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Clinical Therapeutic Solutions 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.
← 44577-0623-02 · Clinical 44577-0711-08 · Clinical →
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.