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Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE 30 mg/mL; 1 mg/mL Cream, 3785 mL — NDC 71061-0765-28 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE 30 mg/mL; 1 mg/mL Cream, 3785 mL — NDC 71061-765-28 (Billing 71061-0765-28)

by CMI Therapy Solutions · 3785 mL in 1 BOTTLE

This is a package of 3,785 mL of Alo Therapeutic Massage MENTHOL, HISTAMINE DIHYDROCHLORIDE 30 mg/mL; 1 mg/mL Cream from CMI Therapy Solutions, marketed since Nov 2016 and currently FDA-listed. It is this product's only package size.

NDC 71061-0765-28
🏷️ FDA NDC (as labeled) 71061-765-28 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 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

NDC database record

One package, one record: these facts belong to NDC 71061-765-28 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71061 labeler · 765 product · 28 package
Package marketed since
Nov 10, 2016
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7106176528 4
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71061-765-28
Product NDC 71061-765
11-digit billing NDC 71061076528
RxCUI 1300288, 1300293
UNII L7T10EIP3A, 3POA0Q644U
Application # M017
SPL Set ID 40f93076-1f68-58e6-e054-00144ff88e88
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-11-10
Route TOPICAL
Dosage form CREAM
Substance MENTHOL; HISTAMINE DIHYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1300288
Why two NDCs? The FDA registers this code as 71061-765-28 — 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 → 71061-0765-28. 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?

Alo Therapeutic Massage is an over-the-counter topical cream marketed under FDA's OTC monograph rules. It contains menthol and histamine dihydrochloride as active ingredients. Menthol is commonly used in topical products for a cooling or soothing sensation on the skin. Histamine dihydrochloride appears in products intended for massage and skin application, though its role in such formulations is not a typical use in standard medical practice.

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
71061-0765-28 You're viewing this Main listing 3785 mL in 1 BOTTLE 2016-11-10 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alo Therapeutic Massage 3 g/100g; .1 g/100g 51457-0000-04 Theraplex 118 g — — FDA listed —
Alo Therapeutic Massage 30 mg/mL; 1 mg/mL 71061-0763-04 CMI 118 ml — — FDA listed —
Alo Therapeutic Massage 30 mg/mL; 1 mg/mL 71061-0764-32 CMI 946 ml — — FDA listed —
Alo Therapeutic Massage 30 mg/mL; 1 mg/mLthis 71061-0765-28 CMI 3785 ml — — FDA listed —
Alo Therapeutic Massage 30 mg/mL; 1 mg/mL 71061-0766-05 CMI 5 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

🏛️
2016
On the market since
Nov 2016
📍
2026
Currently FDA-listed
10 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 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 0A5MM307FC
    A synthetic polymer that absorbs water and forms a thick, gel-like substance. In medicines, it works as a thickener and stabilizer to improve texture and help ingredients stay mixed together in creams, gels, and lotions.
  • 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 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 230OU9XXE4
    A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention in topical products.
  • UNII YD01N1999R
    A waxy substance made from polyethylene glycol and stearic acid. It helps mix oil and water-based ingredients together and serves as an emulsifier and solubilizer in liquid and semi-solid medicines.
  • 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 C3M81465G5
    Spearmint oil is a natural flavoring extract from spearmint plants. It's added to medicines to improve taste and mask bitter flavors, making medications easier to take.
  • UNII 3W1JG795YI
    Sunflower oil is a natural vegetable oil derived from sunflower seeds. It serves as a solvent, lubricant, and carrier in medicines, helping dissolve active ingredients and improve how the medication flows and absorbs in the body.
  • 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 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAqua (deionized Water), Butylene Glycol, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Dimethyl Sulfone (MSM), Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

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

LabelerCMI Therapy Solutions
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code71061
First marketedNov 2016
Product typeHuman Otc Drug
Portfolio4 products on file

More NDCs from CMI Therapy Solutions labeler code 71061

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
🎯 Indications and Usage 16 words ▾

Uses For temporary relief of minor aches and pains associated with backache, arthritis, bruises and sprains.

⏱️ Dosage and Administration 15 words ▾

Directions Apply directly to affected area. Do not use more than four times per day.

⚠️ Warnings 55 words ▾

Warnings For external use only. Avoid contact with eyes. Do not apply to open wounds or damaged skin. If symptoms persist for more than seven days, discontinue use and consult physician. Keep out of reach of children. If swallowed, consult physician. Do not bandage tightly. If pregnant or breast feeding, contact physician prior to use.

🧪 Active Ingredient 9 words ▾

Active ingredients Menthol 3.00% Histamine Dihydrochloride 0.100% External Analgesic

🧪 Inactive Ingredients 36 words ▾

Other Ingredients Aqua (deionized Water), Butylene Glycol, Carbomer, Cetyl Alcohol, Ethylhexylglycerin, Dimethyl Sulfone (MSM), Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Mentha Viridis (Spearmint) Oil, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, SD-Alcohol 40B, Triethanolamine, Xanthan Gum.

🎯 Purpose 2 words ▾

External Analgesic

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 CMI Therapy Solutions. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CMI Therapy 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.
← 71061-0764-32 · CMI 71061-0766-05 · CMI →
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.