HomeNDC Lookup › 58133-0900-04
Real Time Pain Relief Foot Cream Menthol 1.5% 1.5 g/100g Cream, 125 g — NDC 58133-0900-04 package photo

Real Time Pain Relief Foot Cream Menthol 1.5% 1.5 g/100g Cream, 125 g

by Cosmetic Specialty labs, Inc. · 125 g in 1 JAR (58133-900-04)
NDC 58133-0900-04
🏷️ FDA NDC (as labeled) 58133-900-04 billing pads the product segment with a zero
This package
Contains125 g Pack sizes4 compare ↓
OTC Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Jul 14, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
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 2023. 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

FDA NDC (as labeled) 58133-900-04
Product NDC 58133-900
11-digit billing NDC 58133090004
Application # part348
SPL Set ID 61e41c3f-b760-4b3d-e053-2991aa0a3248
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH NOT FINAL
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2023)
Route TOPICAL
Dosage form CREAM
Substance MENTHOL
Why two NDCs? The FDA registers this code as 58133-900-04 — 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 → 58133-0900-04. 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

LabelerCosmetic Specialty labs, Inc.
FDA applicationpart348 (OTC MONOGRAPH NOT FINAL)
Labeler code58133
Product typeHuman Otc Drug
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 →
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 2SBL0E1I0N
    An organic alcohol compound used as a fragrance and flavoring agent in medicines. It helps mask taste or odor and may improve the sensory experience of the product.
  • UNII 344S277G0Z
    Allantoin is a naturally derived compound that helps soften and soothe skin. In medicines, it works as a skin-conditioning agent and may help support wound healing and reduce irritation in topical formulations.
  • 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 JW7FJR3ZLY
    A synthetic form of vitamin E derivative used as an antioxidant in medications. It helps prevent ingredient breakdown and spoilage during storage by protecting the product from oxidation.
  • 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 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 P0M7O4Y7YD
    A plant extract from calendula flowers, traditionally used in formulations. It typically serves as a botanical ingredient that may provide color, fragrance, or skin-conditioning properties to topical products.
  • UNII 00YIU5438U
    Caprylyl glycol is a clear liquid derived from coconut oil. In medicines, it acts as a humectant to retain moisture, a preservative booster to prevent microbial growth, and a solvent to help dissolve or mix other ingredients.
  • UNII QZ239038YC
    A natural extract from the cornflower plant, used as a colorant and flavoring agent to give medicines their appearance and taste.
  • 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 60F80Z61A9
    A fragrant plant oil extracted from chamomile flowers. It's used as a flavoring agent and fragrance in medicines to improve taste and smell, making the product more pleasant to take.
  • UNII 7626GC95E5
    A natural aromatic oil extracted from coriander seeds. Used as a flavoring agent to mask bitter tastes and improve the overall taste of medicines, making them easier to take.
  • 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 S546YLW6E6
    Eucalyptus globulus leaf is a plant-derived ingredient that may serve as a flavoring agent or aromatic component in medications. It is commonly used to add taste or scent to oral formulations.
  • UNII Z82Y2C65EA
    Hydrogenated cottonseed oil is a solid fat made by adding hydrogen to cottonseed oil. It's used in medicines as a binder and lubricant to help hold ingredients together and make tablets easier to compress and release.
  • UNII XK4IUX8MNB
    Hypericum perforatum, also known as St. John's Wort, is a plant extract used in some medicines. It may serve as an active botanical ingredient or flavoring agent depending on the formulation.
  • UNII Q613OCQ44Y
    Isostearyl alcohol is a fatty alcohol derived from plant or petroleum sources. It acts as an emollient and thickener in formulations, helping to soften the product and improve texture and stability.
  • UNII 33X04XA5AT
    Lactic acid is a naturally occurring organic acid derived from milk or plant sources. It lowers and maintains pH in formulations, helps preserve the product, and can enhance ingredient stability and absorption.
  • UNII 7EV65EAW6H
    Lanolin is a waxy substance derived from sheep's wool. It's used in medicines as an emollient and skin-conditioning agent to soften formulations and improve spreadability in topical products like creams and ointments.
  • UNII SA8AR2W4ER
    A natural oil extracted from chamomile flower tops, used as a flavoring and fragrance agent to improve taste and aroma in medicines.
  • UNII G43C57162K
    A natural plant extract from tea tree leaves used in topical formulations. It acts as a fragrance, preservative, and antimicrobial agent to help maintain product freshness and sensory appeal.
  • UNII I9O0E3H2ZE
    Paraffin is a waxy, petroleum-derived substance used as a coating, lubricant, and hardening agent in tablets and capsules. It helps protect the medicine from moisture and gives pills a smooth finish.
  • UNII 4T6H12BN9U
    Petrolatum is a purified mineral oil-based jelly derived from petroleum. In medicines, it acts as an emollient, lubricant, and moisture barrier to soften skin, reduce friction, and help prevent water loss from formulations.
  • 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 7T1F30V5YH
    A synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in liquid formulations.
  • UNII CAL22UVI4M
    A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
  • UNII 32JK994WMC
    Retinyl propionate is a form of vitamin A ester used in medications and supplements. It acts as an active ingredient rather than a typical inactive excipient, providing vitamin A activity in the formulation.
  • UNII 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII 91MBZ8H3QO
    Sodium borate is an inorganic salt compound used in medicines as a buffer to help maintain a stable pH level, and sometimes as a mild preservative or cleansing agent in topical formulations.
  • UNII 0W8RRI5W5A
    A fatty acid derivative used as an emulsifier and surfactant in medications. It helps blend oily and water-based ingredients together to create a stable, uniform product.
  • UNII NHV2K1OUDH
    A plant extract from linden tree flowers, used as a natural flavoring, fragrance, or botanical ingredient to enhance the taste or aroma of the medicine.
  • 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.

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

The official label also statesAllantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

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 DailyMedingredient 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: 40 g 227 g 453 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
Real Time Pain Relief Foot Cream 1.5 g/100gthis 58133-0900-04 Cosmetic 125 g Discontinued
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

📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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
58133-0900-04 You're viewing this 125 g in 1 JAR (58133-900-04) 2014-01-31 Inactivated by FDA
58133-0900-08 227 g in 1 JAR (58133-900-08) 2014-01-31 Inactivated by FDA
58133-0900-14 40 g in 1 JAR (58133-900-14) 2014-01-31 Inactivated by FDA
58133-0900-16 453 g in 1 JAR (58133-900-16) 2014-01-31 Inactivated by FDA

You're viewing one of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 58133-0900-04?
NDC 58133-0900-04 contains 125 g — 125 g in 1 jar.
What is the difference between NDC 58133-0900-04 and NDC 58133-0900-14?
Both are Real Time Pain Relief Foot Cream Menthol 1.5% 1.5 g/100g Cream — the drug itself is identical. NDC 58133-0900-04 is the 125 g package, while NDC 58133-0900-14 is the 40 g package.
What NDC number is used to bill for this package of Real Time Pain Relief Foot Cream Menthol 1.5% 1.5 g/100g Cream?
Bill NDC 58133-0900-04 — the 11-digit billing format is 58133090004. 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 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 Not Final". 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 FDA registers it as 58133-900-04, 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: 58133-0900-04, written without dashes as 58133090004. 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 58133-0900-04, the first segment (58133) is the labeler code FDA assigned to Cosmetic Specialty labs, Inc.; the middle segment (0900) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (04) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 40 g (58133-0900-14), 227 g (58133-0900-08), 453 g (58133-0900-16). 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?
Cosmetic Specialty labs, 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 13 words

USES Temporarily relieves minor pain associated with arthritis muscle strains sprains bruises cramps

⏱️ Dosage and Administration 38 words

DIRECTIONS adults and children over 2 years apply generously to affected area massage into painful area until throughly absorbed into skin repeat as necessary, but no more than 4 times daily Children 2 years or younger:ask a doctor

⚠️ Warnings 78 words

WARNINGS for external use only When using this product use only as directed do not bandage tightly or use with heating pad avoid contact with eyes or mucus membranes do not apply to wounds or damaged skin Stop using and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occur again within a few days redness is present irritation develops If pregnant or breast-feeding ask a health professional before use

🧪 Active Ingredient 4 words

ACTIVE INGREDIENT Menthol 1.5%

🧪 Inactive Ingredients 87 words

INACTIVE INGREDIENTS Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

🎯 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 ↗
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.