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Bellehaven numbing cream Menthol 5 g/100g Cream, 50 g — NDC 85284-0009-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bellehaven numbing cream Menthol 5 g/100g Cream, 50 g — NDC 85284-009-01 (Billing 85284-0009-01)

by BLOOMWELL GARDENS LLC · 50 g in 1 BOTTLE, PLASTIC

This is a package of 50 g of Bellehaven numbing cream Menthol 5 g/100g Cream from BLOOMWELL GARDENS LLC, no longer marketed (first marketed Sep 2025), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 85284-0009-01
🏷️ FDA NDC (as labeled) 85284-009-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Inactivated by FDA ⇄ 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 85284-009-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85284 labeler · 009 product · 01 package
Package marketed since
Sep 4, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 8528400901 8
FDA record last changed
Jul 24, 2026
⚠️
Other active recalls for Menthol (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 20, 2026 — This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality. (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.) · FDA recall D-0458-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85284-009-01
Product NDC 85284-009
11-digit billing NDC 85284000901
RxCUI 1039690
UNII L7T10EIP3A
Application # M017
SPL Set ID 3dfb8e19-5dfc-85b2-e063-6294a90ac4eb
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2026)
Marketing start 2025-09-04
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Quick answers
  • RxCUI (RxNorm): 1039690
Why two NDCs? The FDA registers this code as 85284-009-01 — 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 → 85284-0009-01. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Mostly for temporary relief of minor aches and pains in muscles and joints, like those from arthritis, backache, strains, sprains and bruises. Some products are for other things, s...
  • It depends on the product. Many creams, gels and patches are limited to about 3 to 4 times a day, and patches also have a time limit, often 8 hours. Follow your product label and a...
  • A brief burning feeling can happen when you first apply it and usually fades in several days. But if you get severe burning pain, swelling or blistering, stop using it and call you...
  • No. Don't use menthol products with a heating pad, and avoid local heat or direct sunlight on the area. Rare cases of serious burns have been reported.
📖 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.

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
85284-0009-01 You're viewing this Main listing 50 g in 1 BOTTLE, PLASTIC 2025-09-04 — Inactivated by FDA

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/100gthis 85284-0009-01 BLOOMWELL 50 g — — Discontinued —
External Analgesic Cream with Menthol 5% 5 g/100g 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 —
Advanced Pain Relief Roll-On Gel With 5% Natural Menthol 5 g/100g 62742-4279-02 Allure 1 bottle — — FDA listed —
Procure gel 5 g/100g 55681-0015-63 TWIN 2.9 g — — FDA listed —
SIERQ Numbing 5 g/100g 87152-0006-01 Putian 30 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
Sep 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.

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 9E8X80D2L0
    A synthetic form of vitamin E used as an antioxidant and preservative in medications. It helps prevent the active ingredients from degrading when exposed to oxygen or light.
  • 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 U7L2JP51PR
    Arnica montana flower water is an extract made from arnica flowers. It's used in formulations as a fragrance, preservative, or skin-conditioning agent to add scent and help maintain product stability.
  • 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 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 3C18L6RJAZ
    A plant extract from horse chestnut seeds used in formulations as a natural thickening agent and binder. It helps hold tablet or capsule ingredients together and may improve product texture.
  • 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 1DI56QDM62
    A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.

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

The official label also statesInactive Ingredients Tocopheryl Acetate, Emu Oil. Propylene Glycol, Arnica, Glycerin, Menthol, Aescinus Hippocastanum (Horse Chestnut)Extract, Lecithin(Soybean)Curcuma Longa Extract, Aqua

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

LabelerBLOOMWELL GARDENS LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85284
First marketedSep 2025
Product typeHuman Otc Drug
Portfolio9 products on file

More NDCs from BLOOMWELL GARDENS LLC labeler code 85284

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 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 14 words ▾

For the temporary relief of localized pain, itching or discomfort from minor skin irritations.

⏱️ Dosage and Administration 82 words ▾

When practical, clean the area within mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day. Children under 12 years of age, consult a doctor. To use finger cots: roll one finger cot cover the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

⚠️ Warnings 9 words ▾

Warnings (For external use only) For external use only

🧪 Active Ingredient 4 words ▾

Active Ingredients .......5% Menthol.

🧪 Inactive Ingredients 19 words ▾

Inactive Ingredients Tocopheryl Acetate, Emu Oil. Propylene Glycol, Arnica, Glycerin, Menthol, Aescinus Hippocastanum (Horse Chestnut)Extract, Lecithin(Soybean)Curcuma Longa Extract, Aqua

🎯 Purpose 2 words ▾

Topical Analgesic

📄 When Using This Product 33 words ▾

·Do not get into the eyes.* Do not exceed recommended dosage unless directed by a doctor." Do not put this product into the rectum by using fingers or any mechanical device or applicator.

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop using and ask a doctor if Condition worsens or does not improve within 7 days Allergic reaction occurs to ingredients in this product. Symptom being treated does not subside or if redness irritation, swelling, pain, or other symptoms develop or increase Symptoms clear up and return within a few days.

🤰 If Pregnant or Breast-Feeding 10 words ▾

lf pregnant or breastfeeding, ask a health professional before use.

📄 Keep Out of Reach of Children 13 words ▾

lf swallowed, get medical help. Do not use if allergic to any ingredients.

📄 Other Information 19 words ▾

Store at room temperature 59°-86°F（15-30°C）.Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.

📄 Package Label / Principal Display Panel 3 words ▾

PRINCIPAL DISPLAY PANEL

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

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 Menthol — the ingredient across all brands.

Top reported reactions

Pain3,545
Fatigue3,324
Nausea3,269
Headache3,025
Dyspnoea2,471
Diarrhoea2,208
Pneumonia2,151

Age at onset

Neonate144
Infant64
Child375
Adolescent265
Adult5,396
Elderly3,493

Reporter sex

54,495 reports
Male · 36%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization18,793
Life-threatening4,358
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 4,676 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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
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.
← 85284-0008-01 · BLOOMWELL 85284-0010-01 · 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.