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Arthritis Pain Relief Cream Histamine Dihydrochloride .00025 g/g Cream — NDC 61577-8120-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Arthritis Pain Relief Cream Histamine Dihydrochloride .00025 g/g Cream — NDC 61577-8120-1 (Billing 61577-8120-01)

by Sombra Cosmetics Inc. · 1 JAR in 1 CARTON / 59 g in 1 JAR

This is a package of Arthritis Pain Relief Cream Histamine Dihydrochloride .00025 g/g Cream from Sombra Cosmetics Inc., marketed since Oct 2024 and currently FDA-listed. It is the main listing for this product, which comes in 7 package sizes.

NDC 61577-8120-01
🏷️ FDA NDC (as labeled) 61577-8120-1 billing pads the package segment with a zero
This package
Contains59 g in 1 jar Pack sizes7 compare ↓
Main listing for product 61577-8120 · Also comes in: 119 g 61577-8120-5 266 g 61577-8120-8 59 g 61577-8120-2 59 g 61577-8120-3 119 g 61577-8120-4 266 g 61577-8120-9
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 61577-8120-1 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
61577 labeler · 8120 product · 1 package
Package marketed since
Oct 23, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 6157781201 5
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 61577-8120-1
Product NDC 61577-8120
11-digit billing NDC 61577812001
RxCUI 1091387
UNII 3POA0Q644U
Application # M017
SPL Set ID 523333ee-eccd-bcf7-e063-6394a90aea60
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-23
Route TOPICAL
Dosage form CREAM
Substance HISTAMINE DIHYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1091387
Why two NDCs? The FDA registers this code as 61577-8120-1 — 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 → 61577-8120-01. 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 Other immunostimulants class.

Drug family (ATC) Other immunostimulants, Tests for gastric secretion
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 cream marketed as an over-the-counter monograph product under FDA's established guidelines for its drug category. The active ingredient, histamine dihydrochloride, is typically used in topical formulations to stimulate local blood flow and promote circulation in the skin. Products containing this ingredient are commonly applied to areas of joint or muscle discomfort as part of pain-relief cream formulations.

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.
Try another pack size: 119 g 266 g 59 g 59 g 119 g 266 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
61577-8120-02 61577-8120-2 59 g in 1 JAR 2019-12-10 — Inactivated by FDA
61577-8120-03 61577-8120-3 59 g in 1 TUBE 2019-12-10 — Inactivated by FDA
61577-8120-04 61577-8120-4 119 g in 1 JAR 2019-12-10 — Inactivated by FDA
61577-8120-09 61577-8120-9 266 g in 1 JAR 2019-12-10 — Inactivated by FDA
61577-8120-01 You're viewing this Main listing 1 JAR in 1 CARTON / 59 g in 1 JAR 2024-10-23 — Active
61577-8120-05 61577-8120-5 1 JAR in 1 CARTON / 119 g in 1 JAR 2024-10-23 — Active
61577-8120-08 61577-8120-8 1 JAR in 1 CARTON / 266 g in 1 JAR 2024-10-23 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 1 jar in 1 carton / 59 g in 1 jar.
What NDC number is used to bill for this package of Arthritis Pain Relief Cream Histamine Dihydrochloride .00025 g/g Cream?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Walgreens Arthritis Pain Relief Cream .00025 g/g 00363-5301-40 Walgreens 113 g — — FDA listed —
Arthritis Pain Relief Cream .00025 g/gthis 61577-8120-01 Sombra 1 jar — — FDA listed —
CVS Arthritis Pain Relief .025 g/100g 69842-0301-60 CVS 1 jar — — FDA listed —
AMINO ACTIVE Topical Analgesic Cream .25 mg/mL 82908-0357-00 VIREO 81.33 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 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 WR1WPI7EW8
    A synthetic form of vitamin E used as an antioxidant. It prevents oils and fats in the medicine from breaking down and becoming rancid, helping keep the product stable during storage.
  • UNII 3XUS85K0RA
    Butylene glycol is a clear liquid derived from petroleum or plants that acts as a humectant, solvent, and preservative booster in medicines. It helps keep formulations stable, dissolve active ingredients, and maintain moisture in topical products.
  • 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 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 344821WD61
    Emu oil is a natural fat derived from emu birds, used in some medicines as an emollient and penetration enhancer to help active ingredients absorb through the skin and soften the formulation.
  • UNII EG3PA2K3K5
    Ethylhexyl stearate is a waxy oil made from stearic acid and ethylhexyl alcohol. In medicines, it acts as an emollient and thickener to improve texture and help the product spread smoothly on skin or dissolve properly.
  • 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 1FW7WLR731
    Glucosamine sulfate is a natural compound derived from shellfish or made in laboratories. In medications, it acts as an active therapeutic ingredient rather than an inactive excipient, though it may also serve as a filler or binder in some formulations.
  • UNII R9N3379M4Z
    Sunflower seed is a plant-derived ingredient used as a filler and source of oil in medications. It helps add bulk to the formulation and may serve as a natural binding or lubricating component.
  • 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 E2KR9C9V2I
    Polyacrylamide is a synthetic polymer used as a thickening agent and binder in medications. It helps create the proper texture and hold ingredients together in the formulation.
  • UNII 1VPU26JZZ4
    Potassium sorbate is a salt derived from sorbic acid, a naturally occurring preservative. It prevents growth of mold, yeast, and some bacteria, extending the medicine's shelf life.
  • UNII 1K7417JX6Q
    A synthetic surfactant made from propylene glycol and fatty alcohols. It helps dissolve, suspend, or mix ingredients that don't naturally blend together in liquid medicines and personal care products.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII H5BJH23Z9A
    A natural polymer extracted from porcine (pig) cartilage tissue. It acts as a binder to hold tablet ingredients together and may improve the product's texture and consistency during manufacturing.
  • UNII 05I15JNI2J
    A synthetic polymer that absorbs and holds moisture. Used in tablets and capsules as a super-disintegrant to help the medicine break apart quickly when swallowed, allowing faster drug release.
  • UNII MP1J8420LU
    A salt derived from edetic acid that binds to trace metals in medicines. It serves as a chelating agent and preservative to prevent metal-catalyzed breakdown of the drug and extend shelf life.
  • 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.

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

The official label also statesAqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

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

LabelerSombra Cosmetics Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61577
First marketedOct 2024
Product typeHuman Otc Drug
Portfolio12 products on file

More NDCs from Sombra Cosmetics Inc. labeler code 61577

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 44 words ▾

Indications and Usage Section For use by adults and children over 12 years. Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily. Children 12 years or younger consult a physician.

⏱️ Dosage and Administration 12 words ▾

Dosage and Administration Apply no more than 3 to 4 times daily.

⚠️ Warnings 80 words ▾

Warnings Section For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in the product. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad. Stop use and ask doctor if: rash appears. condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

🧪 Active Ingredient 5 words ▾

Active Ingredients Histamine Dihydrochloride .025%

🧪 Inactive Ingredients 38 words ▾

Inactive Ingredients Aqua (Purified Water), Butylene Glycol, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Methylsulfonylmethane (MSM), Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Chondroitin Sulfate, Glucosamine Sulfate

🎯 Purpose 3 words ▾

Purpose External Analgesic

📄 When Using This Product 63 words ▾

Uses For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backaches, strains & bruises.

Directions For use by adults and children over 12 years. Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily. Children 12 years or younger consult a physician.

📄 Stop Use and Ask a Doctor If 79 words ▾

Warnings For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in the product. When using this product: avoid contact with eyes. If product gets into eyes, rinse thoroughly with water. Do not bandage tightly or use a heating pad. Stop use and ask doctor if: rash appears. condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

📄 Keep Out of Reach of Children 25 words ▾

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

📄 Questions or Comments 5 words ▾

Questions or Comments Call 1-888-600-4642

📄 Recent Major Changes 70 words ▾

Indications and Usage 12/2019 Submission Indications and Usage Section: For temporary relief of minor aches and pains of muscles and joints associated with arthritis 3/2026 Submission Indications and Usage Section: For use by adults and children over 12 years. Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily. Children 12 years or younger consult a physician.

📄 Package Label / Principal Display Panel 8 words ▾

AD Arthritis 9oz Carton AD Arthritis 9oz Carton

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

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 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 6 other package presentations of this same product, including 1 jar (61577-8120-05), 1 jar (61577-8120-08), 59 g (61577-8120-02). 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.
← 61577-7365-01 · SOMBRA 61577-8121-02 · 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.