Home › NDC Lookup › Ingredients › Sombra Max › 61577-3440-02
Sombra Max 6 g/100g; .025 g/100g; 3 g/100g; .025 g/100g; 12 g/100g Cream, 1 g — NDC 61577-3440-02 package photo

Sombra Max 6 g/100g; .025 g/100g; 3 g/100g; .025 g/100g; 12 g/100g Cream, 1 g

by Sombra Cosmetics Inc. · 1 g in 1 PACKET (61577-3440-2)
NDC 61577-3440-02
🏷️ FDA NDC (as labeled) 61577-3440-2 billing pads the package segment with a zero
This package
Contains1 g Pack sizes2 compare ↓
Also comes in: 1 g 61577-3440-01
OTC On market Non-controlled
🗂️ Data synced Aug 27, 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

🆔 Identity & classification

FDA NDC (as labeled) 61577-3440-2
Product NDC 61577-3440
11-digit billing NDC 61577344002
UNII WW64GZ6LQY, 3POA0Q644U, 5TJD82A1ET, S07O44R1ZM, LAV5U5022Y
Application # M017
SPL Set ID 41623a46-e6e7-907e-e063-6394a90afc4c
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-01
Route TOPICAL
Dosage form CREAM
Substance MENTHOL GLUCURONIDE; HISTAMINE DIHYDROCHLORIDE; CAMPHOR (SYNTHETIC); CAPSAICIN; METHYL SALICYLATE
Why two NDCs? The FDA registers this code as 61577-3440-2 — a 5-4-1 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 package segment → 61577-3440-02. 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.

🏭 Manufacturer & labeler

LabelerSombra Cosmetics Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61577
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio12 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.

🩺 Clinical

🧪 What is this product?

Sombra Max is a topical cream marketed as an over-the-counter monograph product. It contains multiple ingredients commonly used in topical pain-relief products: menthol and camphor, which produce a cooling sensation; methyl salicylate, which is a salicylate compound used in liniments; capsaicin, derived from peppers; and histamine dihydrochloride. The cream is applied to the skin and is typically used to provide temporary relief of minor muscle and joint discomfort.

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.

🧪 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 D072FFP9GU
    Cetyl esters wax is a waxy substance made from natural or synthetic fatty acids. It's used as a binder, hardening agent, and coating material to give tablets and capsules their structure and texture.

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

The official label also statesInactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.

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.

💲 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.
Try another pack size: 1 g
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sombra Max 6 g/100g; .025 g/100g; 3 g/100g; .025 g/100g; 12 g/100gthis 61577-3440-02 Sombra 1 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

🏛️
2026
On the market since
Jan 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61577-3440-01 1 g in 1 CONTAINER (61577-3440-1) 2026-01-01 Active
61577-3440-02 You're viewing this 1 g in 1 PACKET (61577-3440-2) 2026-01-01 Active

Pack size FAQ

What quantity is in NDC 61577-3440-02?
NDC 61577-3440-02 contains 1 g — 1 g in 1 packet.
What is the difference between NDC 61577-3440-02 and NDC 61577-3440-01?
Both are Sombra Max 6 g/100g; .025 g/100g; 3 g/100g; .025 g/100g; 12 g/100g Cream — the drug itself is identical. NDC 61577-3440-02 is the 1 g package, while NDC 61577-3440-01 is the 1 g package.
What NDC number is used to bill for this package of Sombra Max 6 g/100g; .025 g/100g; 3 g/100g; .025 g/100g; 12 g/100g Cream?
Bill NDC 61577-3440-02 — the 11-digit billing format is 61577344002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 61577-3440-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 61577-3440-02, written without dashes as 61577344002. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 61577-3440-02, the first segment (61577) is the labeler code FDA assigned to Sombra Cosmetics Inc.; the middle segment (3440) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
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 Sombra Cosmetics Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 g (61577-3440-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sombra Cosmetics Inc. 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.

📄 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
🎯 Indications and Usage 19 words ▾

Uses Temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, sprains

⏱️ Dosage and Administration 39 words ▾

Directions Directions: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age: consult a doctor.

⚠️ Warnings 78 words ▾

Warnings For external use only. Do not use if allergic to salicylates (including aspirin), on wounds or damaged skin or with a heat source. When using this product: avoid bandaging tightly, avoid contact with eyes, keep out of reach of children. If swallowed, get medical help or contact a Posion Control Center right away. Stop use and ask doctor if: condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

🧪 Active Ingredient 18 words ▾

Active Ingredients Section OTC Methyl Salicylate 12% Menthol USP 6% Camphor USP 3% Capsaicin 0.025% Histamine Dihydrochloride 0.025%

🧪 Inactive Ingredients 33 words ▾

Inactive Ingredients Inactive Ingredients: Aloe Barbadensis Leaf Extract, Carbomer, Cetearyl Alcohol, Cetyl Esters, Caprylyl Glycol, Glycerin, Phenoxyethanol, Polysorbate 60, Purified Water, Sodium Carbonate, Stearic Acid, Tocopheryl Acetate (Vitamin E), Yucca Schidigera Stem Extract.

🎯 Purpose 4 words ▾

Purpose Purpose External Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61577-3242-04 · SOMBRA 61577-7365-01 · SOMBRA →
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.