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External Analgesic Cream with Menthol 5% 5 g/100g Cream, 50 g

by BLOOMWELL GARDENS LLC · 50 g in 1 BOTTLE (85284-010-01)
NDC 85284-0010-01
🏷️ FDA NDC (as labeled) 85284-010-01 billing pads the product segment with a zero
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) 85284-010-01
Product NDC 85284-010
11-digit billing NDC 85284001001
RxCUI 1039690
UNII L7T10EIP3A
Application # M017
SPL Set ID 402faa27-5305-c73d-e063-6394a90a36f2
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-02
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Why two NDCs? The FDA registers this code as 85284-010-01 — 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 → 85284-0010-01. 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.

🏭 Manufacturer & labeler

LabelerBLOOMWELL GARDENS LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85284
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio9 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

📗 Our plain-language guide HelloPharmacist
  • Menthol is found in a lot of over-the-counter topical products — creams, gels, patches, sprays, and powders. Depending on the product, it's used to temporarily ease minor muscle an...
  • Start with clean, dry skin — free of lotions or creams — before applying the patch. Peel the backing off and press the sticky side firmly to the sore area. Most menthol patches sho...
  • Yes, a mild burning or tingling feeling right after applying a menthol product is common and usually settles down within a few days of regular use. What's not normal is severe burn...
  • Is that burning sensation after I apply it normal?
📖 Read our full Menthol guide →

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 TR046Y3K1G
    A liquid alcohol derived from petroleum or plant sources. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 607YAE70V1
    A plant extract from chrysanthemum flowers used as a natural flavoring or coloring agent in medicines. It may help improve taste or add visual appeal to the formulation.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • UNII G1L3HT4CMH
    A synthetic compound used in medicines as a preservative and antimicrobial agent. It helps prevent bacterial and fungal growth, extending the product's shelf life.
  • UNII A4IWO4DDZ9
    A plant extract from spearmint leaves, used as a flavoring agent and to add a cooling, refreshing taste to medicines. It may also have mild soothing properties in the formulation.
  • UNII 7YC686GQ8F
    A synthetic oily substance made from castor oil. It works as a solubilizer and emulsifier to help mix oily and water-based ingredients together in the medicine.
  • UNII VHJ480553K
    Portulaca grandiflora leaf is a plant-derived ingredient used as a natural colorant and antioxidant in formulations. It may help preserve product stability and add visual appeal to the medicine.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • 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.

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

The official label also statesWater, Propylene Glycol, Carbomer Homopolymer, Glycerin, Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol, Mentha Arvensis Leaf, Chrysanthemum Indicum Top, Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

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.
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
Joint and Muscle Pain 50 mg/g 59899-0022-00 Shaklee 85 g — — FDA listed —
Advanced Pain Relief Cream With 5 % Natural Menthol 5 g/100g 62742-4278-02 Allure 1 tube — — FDA listed —
Cheezheng Pain Relief Cream 5 g/100g 66506-0184-01 Tibet 1 tube — — FDA listed —
KT Pain Relief Cream Magnesium with Cooling 5% Menthol 5 g/100mL 69693-0108-25 Clarion 1 ml — — FDA listed —
Rubbing Dots Natural Cool Pain Relief 50 mg/mL 73294-0005-04 Awesome 110 ml — — FDA listed —
Mg Plus Menthol With Hemp 5.6 g/112g 76348-0471-04 RENU 112 g — — Discontinued —
Dr PAINES Pain Relief 50 mg/g 78970-0161-03 DOCTOR 1 tube — — FDA listed —
SCALAR Pain Relief Cream 50 mg/mL 80883-0097-00 Miracle 1 jar — — FDA listed —
FISICO Arthrozene Pain Cream 50 mg/g 83204-0375-00 FISICO 96.4 g — — FDA listed —
TIDL CLINICAL CRYOTHERAPY MENTHOL Cream 5 g/.1L 84214-0010-01 Shenzhen 3.785 l — — FDA listed —
Dermfree Numbing 5 g/100g 85248-0158-01 Jiangxi 50 g — — FDA listed —
Healmusz Numbing 5 g/100g 85248-0160-01 Jiangxi 50 g — — FDA listed —
Sylvirene Numbing 5 g/100g 85248-0163-01 Jiangxi 50 g — — FDA listed —
ANIXIKE Numbing 5 g/100g 85248-0167-01 Jiangxi 30 g — — FDA listed —
Puvida Numbing 5 g/100g 85248-0172-01 Jiangxi 50 g — — FDA listed —
Bellehaven numbing cream 5 g/100g 85284-0009-01 BLOOMWELL 50 g — — Discontinued —
External Analgesic Cream with Menthol 5% 5 g/100gthis 85284-0010-01 BLOOMWELL 50 g — — FDA listed —
tuiwaro Numbing Cream 5 g/100g 87408-0012-01 Guangzhou 1 bottle — — FDA listed —
Aemerry Numbing Cream 2.5 g/50g 87615-0002-01 Da 50 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85284-0010-01 You're viewing this 50 g in 1 BOTTLE (85284-010-01) 2025-10-02 Active

🧭 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 — Not published for this NDC No photo available yet for this listing.
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 85284-010-01, 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: 85284-0010-01, written without dashes as 85284001001. 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 85284-0010-01, the first segment (85284) is the labeler code FDA assigned to BLOOMWELL GARDENS LLC; the middle segment (0010) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 BLOOMWELL GARDENS LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
BLOOMWELL GARDENS LLC 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 21 words ▾

For the temporary relief of minor aches and pains of muscles and joints associated with: simple backache, arthritis, strains, bruises, sprains

⏱️ Dosage and Administration 46 words ▾

- Adults and children 12 years and older: Clean the affected area with mild soap and warm water, then pat dry. Apply a thin, even layer to the affected area not more than 3 to 4 times daily. - Children under 12 years: consult a doctor

⚠️ Warnings 4 words ▾

For external use only

🧪 Active Ingredient 4 words ▾

Active ingredient Menthol 5%

🧪 Inactive Ingredients 22 words ▾

Water, Propylene Glycol, Carbomer Homopolymer, Glycerin, Edetate Disodium, Hydroxyacetophenone, 1,2-Hexanediol, Mentha Arvensis Leaf, Chrysanthemum Indicum Top, Portulaca, Polyoxyl 40 Hydrogenated Castor Oil

🎯 Purpose 7 words ▾

Temporary relief of minor aches and pains

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85284-0009-01 · BLOOMWELL 85284-0011-01 · BLOOMWELL →
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.