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Australian Dream Back Pain Histamine Dihydrochloride .0005 g/g Cream — NDC 61577-8121-05 package photo

Australian Dream Back Pain Histamine Dihydrochloride .0005 g/g Cream

by Sombra Cosmetics Inc. · 1 JAR in 1 CARTON (61577-8121-5) / 119 g in 1 JAR (61577-8121-4)
NDC 61577-8121-05
🏷️ FDA NDC (as labeled) 61577-8121-5 billing pads the package segment with a zero
This package
Contains119 g in 1 jar Pack sizes5 compare ↓
Also comes in: 59 g 61577-8121-03 266 g 61577-8121-08 59 g 61577-8121-02 119 g 61577-8121-04
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 61577-8121-5
Product NDC 61577-8121
11-digit billing NDC 61577812105
RxCUI 1542820
UNII 3POA0Q644U
UPC 0694603827142
Application # M017
SPL Set ID 5256a63e-e6da-84c1-e063-6294a90a8dff
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-09-29
Route TOPICAL
Dosage form CREAM
Substance HISTAMINE DIHYDROCHLORIDE
Why two NDCs? The FDA registers this code as 61577-8121-5 — 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 → 61577-8121-05. 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 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.

🏭 Manufacturer & labeler

LabelerSombra Cosmetics Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code61577
First marketedSep 2023
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?

Australian Dream Back Pain Histamine Dihydrochloride is a topical cream applied to the skin, marketed as an over-the-counter monograph product. The active ingredient is histamine dihydrochloride, a compound that in topical form is typically used to help relieve localized back pain and muscle discomfort. This product is regulated under the FDA's established rules for over-the-counter pain relief creams rather than as an individually approved drug application.

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 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 OZ0E5Y15PZ
    A plant extract from arnica flowers, used as a flavoring agent or fragrance component in medicines. It may also provide mild soothing properties to certain topical formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII X7B7P649WQ
    A plant extract from boswellia serrata tree resin, used as a natural filler and binding agent in capsules and tablets to add bulk and help hold the formulation together.
  • UNII U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • 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 FGL3685T2X
    Chamomile is a plant extract used in medications as a flavoring agent and for its mild soothing properties in formulations. It helps improve taste and aroma of the medicine.
  • 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 J5P04QW0CF
    A fungus used as a filler and natural colorant in supplements and medicines. It may help standardize the product's appearance and texture while adding bulk.
  • UNII C5529G5JPQ
    Ginger is a plant-derived ingredient used as a flavoring agent to add taste and aroma to medicines. It may also provide mild soothing properties to support product palatability.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • 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 DE08037SAB
    Magnesium sulfate is a mineral salt that acts as an osmotic agent in medications. It draws water into the intestines to soften stool or is used as a filler and processing aid in some solid dosage forms.
  • UNII 2679MF687A
    Niacin is a B vitamin used in medications as a nutritional supplement and pH buffer. It helps stabilize the product and may support formulation integrity during manufacturing and storage.
  • 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 285CYO341L
    Sodium polyacrylate is a synthetic polymer that absorbs and holds water. In medicines, it acts as a disintegrant, helping tablets break apart quickly in the stomach, and as a binder, holding tablet ingredients together.
  • 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 R0ZB2556P8
    Tocopherol is a form of vitamin E derived from plant oils. It acts as an antioxidant in medicines to prevent oils and fats from breaking down and spoiling during storage.
  • UNII 3T5PCR2H0C
    A synthetic detergent and emulsifier made from plant-derived materials. It helps mix oil and water components together and improves how the medicine spreads or absorbs in the body.
  • UNII 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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.

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

The official label also statesAloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Turmeric Extract, Zingiber Officinalis (Ginger) 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: 59 g 266 g 59 g 119 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
Australian Dream Back Pain .0005 g/gthis 61577-8121-05 Sombra 1 jar — — FDA listed —
Glucosamine Cream EXTRA STRENGTH .05 g/100g 78983-0101-85 IDEAZ, 85 g — — FDA listed —
2nd CHANCE MOBILITY Pain Relief .5 mg/g 83984-0441-00 ALPHA 96 g — — FDA listed —
Pain Relieving Cream .05 g/100g 85063-0101-85 Mediapower, 85 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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Australian Dream Back Pain (this brand).

Top reported reactions

Colon Cancer Metastatic3
Diarrhoea3
Back Pain2
Dizziness2
Allergy Test Positive1
Ankylosing Spondylitis1
Anxiety1

Age at onset

Adult1
Elderly1

Reporter sex

10 reports
Male · 40%
Female · 60%

Serious outcomes

Hospitalization1
Life-threatening1
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 4 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
61577-8121-02 59 g in 1 JAR (61577-8121-2) 2022-06-10 Active
61577-8121-04 119 g in 1 JAR (61577-8121-4) 2022-06-10 Active
61577-8121-03 1 JAR in 1 CARTON (61577-8121-3) / 59 g in 1 JAR (61577-8121-2) 2023-09-29 Active
61577-8121-05 You're viewing this 1 JAR in 1 CARTON (61577-8121-5) / 119 g in 1 JAR (61577-8121-4) 2026-02-20 Active
61577-8121-08 1 JAR in 1 CARTON (61577-8121-8) / 266 g in 1 JAR (61577-8121-9) 2024-01-18 Active

Pack size FAQ

What quantity is in NDC 61577-8121-05?
NDC 61577-8121-05 is listed by the FDA — 1 jar in 1 carton / 119 g in 1 jar.
What NDC number is used to bill for this package of Australian Dream Back Pain Histamine Dihydrochloride .0005 g/g Cream?
Bill NDC 61577-8121-05 — the 11-digit billing format is 61577812105. 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 61577-8121-5, 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: 61577-8121-05, written without dashes as 61577812105. 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 61577-8121-05, the first segment (61577) is the labeler code FDA assigned to Sombra Cosmetics Inc.; the middle segment (8121) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (05) 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 4 other package presentations of this same product, including 1 jar (61577-8121-03), 1 jar (61577-8121-08), 59 g (61577-8121-02). 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.

📄 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 50 words ▾

Indications & Usage Section For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and bruises. 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.

⏱️ Dosage and Administration 26 words ▾

Dosage and Administration Apply a thin layer to pain site and massage until thoroughly absorbed into skin. Apply no more than 3 to 4 times daily.

⚠️ Warnings 91 words ▾

Warnings Section For external use only. Do not use on wounds or damaged skin or if you are allergic to ingredients in this 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. If pregnant or breast feeding, ask a health professional before use.

🧪 Active Ingredient 5 words ▾

Active Ingredients Histamine Dihydrochloride .025%

🧪 Inactive Ingredients 75 words ▾

Inactive Ingredients Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Purified Water), Ascorbic Acid (Vitamin C), Arnica Montana Flower Extract, Boswellia Serrata Extract, Bromelain, Butylene Glycol, Chamomilla Recutita (Chamomile) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Ganoderma Lucidum (Reishi Mushroom) Extract, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Seed Oil, C13-14 Isoparaffin, Laureth-7, Magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tochopheryl Acetate (Vitamin E), Trideceth-6, Turmeric Extract, Zingiber Officinalis (Ginger) Extract

🎯 Purpose 3 words ▾

Purpose Topical Analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 61577-8120-02 · Sombra 61578-0213-01 · Dental →
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.