NDC 70512-015-15 (70512-0015-15) — SynoFlex Patch 40 mg/g; 50 mg/g Patch

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70512-015-15

Product NDC 70512-015

11-digit billing NDC 70512001515

NCPDP billing unit EA — each (per item)

RxCUI 2600301

UNII V13007Z41A, L7T10EIP3A

UPC 0070512015151

Application # M017

SPL Set ID de2042c4-6c5e-7365-e053-2a95a90ada2a

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 2022-04-28

Route TOPICAL

Dosage form PATCH

Substance LIDOCAINE HYDROCHLORIDE; MENTHOL

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

GPI-14 90859902885955

GPI class SynoFlex

GCN Seq No 073512

GCN 37916

HICL code 036762

Ingredient (HICL) Lidocaine Hcl/Menthol

HIC1 code Q

Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other

HIC2 code Q5

Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin

HIC3 code Q5H

Therapeutic class — specific (HIC3) Topical Local Anesthetics

AHFS code 72:00.00.00

AHFS class Local Anesthetics

FDB label name SYNOFLEX 4%-5% PATCH

FDB brand name Synoflex

Legend status O — Over-the-counter (OTC) drug or device

Quick answers

GSN (GCN sequence number): 073512
GCN: 37916
GPI-14 (Medi-Span): 90859902885955
HICL (First Databank): 036762
AHFS class code: 72:00.00.00
RxCUI (RxNorm): 2600301

Why two NDCs? The FDA registers this code as 70512-015-15 — 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 → 70512-0015-15. 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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

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.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name SYNOFLEX 4%-5% PATCH Ingredient Lidocaine Hcl/Menthol

🧪 What is this product?

SynoFlex Patch is a topical patch marketed as an over-the-counter monograph product containing lidocaine hydrochloride and menthol. Lidocaine is a local anesthetic, and menthol is a cooling agent. Together, these ingredients are typically used in patches applied to the skin to provide temporary relief of minor aches and pains. This product is not individually FDA-approved but is marketed under the FDA's established rule-book for over-the-counter topical analgesic products.

Patient education

📘 MedlinePlus patient leaflet ↗

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.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 6, 2026

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	$52.80	$158.39 / 3 pouches
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

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.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · through Q1 2025
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
70512-0015-15 You're viewing this Main listing	3 POUCH in 1 BOX / 5 g in 1 POUCH	2022-04-28	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
SynoFlex Patch 40 mg/g; 50 mg/gthis 70512-0015-15	Sola	3 pouches	—	—	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.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Oct 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2022

On the market since

Apr 2022

📍

2026

Currently FDA-listed

4 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.

FDA Orange Book · refreshed Oct 3, 2026

What it looks like

ShapeRectangle

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.

FDA label on DailyMed · label index refreshed Oct 6, 2026

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 J94PBK7X8S
A synthetic polymer derived from acrylic acid monomers. In medicines, it's used as a binder to hold tablet ingredients together and sometimes as a coating agent to control where and how the drug releases in the body.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesAcrylic Adhesive

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.

FDA label on DailyMed · label index refreshed Oct 6, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

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

LabelerSola Pharmaceuticals

FDA applicationM017 (OTC MONOGRAPH DRUG)

Labeler code70512

First marketedApr 2022

Product typeHuman Otc Drug

Portfolio12 products on file

More NDCs from Sola Pharmaceuticals labeler code 70512

🔎 All NDCs from Sola Pharmaceuticals

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 openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel

🎯 Indications and Usage 7 words ▾

Uses For the temporary relief of pain

⏱️ Dosage and Administration 57 words ▾

Directions Adults and children over 12 years: Clean and dry the affected area Open pouch and remove one patch Remove the protective film from the patch and apply patch to the affected area Reseal pouch containing unused patches after each use Use 1 patch for up to 12 hours Children 12 years or younger: ask a doctor

⚠️ Warnings 5 words ▾

Warnings For external use only

🧪 Active Ingredient 7 words ▾

Active Ingredients Lidocaine Hcl 4% Menthol 5%

🧪 Inactive Ingredients 4 words ▾

Other Ingredients Acrylic Adhesive

🎯 Purpose 3 words ▾

Purpose Topical Anesthetic

📄 Do Not Use 32 words ▾

Do not use More than 1 patch on your body at a time or on cut, irritated, or swollen skin On puncture wounds For more than one week without consulting a doctor

📄 When Using This Product 119 words ▾

When using this product use only as directed. Read and follow all directions and warnings on this label rare cases of serious burns have been reported with products of this type do not apply to wounds or damaged, broken, or irritated skin do not allow contact with the eyes and mucous membranes do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analgesics dispose of used patch in a 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 48 words ▾

Stop use and ask 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 10 words ▾

If pregnant or breast-feeding ask a healthcare professional before use.

📄 Keep Out of Reach of Children 21 words ▾

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

📄 Other Information 13 words ▾

Other Information Avoid storing product in direct sunlight Protect product from excessive moisture

📄 Questions or Comments 4 words ▾

Questrions or comments? 866-747-7365

📄 Package Label / Principal Display Panel 32 words ▾

Manufactured for: Sola Pharmaceuticals LLC Baton Rouge, LA 70810 SynoFlex Patch Topical Pain Patch For temporary relief of pain NDC 70512-015-15 Qty: 15 Flex Patches (5 per Resealable Pouch) x 3 SnyoFlex

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q1 2025 · 1 quarter of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

116

Units reimbursed last 4 qtrs

3.4K

Gross reimbursed last 4 qtrs

$179K

Avg / prescription

$1,542.92

Avg / unit

$52.7960

Latest quarter Q1 2025

116Rx

Fee-for-service vs managed care ⓘ

100% FFS

Fee-for-service · 116 Rx Managed care · 0 Rx

State Medicaid map

Units reimbursed · per 100k residents

93.793.7

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 Connecticut 93.7 /100k

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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)	✓ Available

“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 Sola Pharmaceuticals. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Sola Pharmaceuticals 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.

Related NDC lookups

🧪 All Synoflex Patch NDCsSame ingredient 🏭 All Sola labeler NDCsLabeler code 70512 📚 All Amide Local Anesthetic NDCsDrug class

Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Topical Local Anesthetics.

Pramoxine Hcl 00316-0230-75 Dyclonine Hcl 00362-3971-05 Lidocaine Hcl 00536-1139-20 Dibucaine 00536-1211-95 Tetracaine/Benzocaine/Butamben 10223-0201-03 Benzocaine 16864-0640-01 Benzocaine/Benzethon Cl 16864-0670-01 Benzocaine/Menthol 16864-0680-01 Lidocaine/Aloe Vera 46122-0555-28 Lidocaine/Menthol 46122-0574-21 Lidocaine Hcl/Benzalkonium Chl 46122-0656-25 Lidocaine 50804-0838-05 Benzocaine/Resorcinol 63868-0949-01 Dyclonine Hcl/Benzethonium Cl 70000-0599-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

First Databank (licensed) · refreshed Oct 1, 2026

SynoFlex Patch 40 mg/g; 50 mg/g Patch — NDC 70512-015-15 (Billing 70512-0015-15)

NDC database record

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

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

RxNorm drug class

Clinical

Patient education

Supplement & herbal interactions

Pricing

Packaging — all sizes for this product

Therapeutic equivalents

Availability & generic status

What it looks like

Inactive Ingredients / Excipients

Inactive ingredient FAQ

Manufacturer & labeler

More NDCs from Sola Pharmaceuticals labeler code 70512

FDA label — Drug Facts FDA SPL

Medicaid utilization & spend

About this NDC listing & data coverage

Questions about this listing