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Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion, 222 mL — NDC 00316-0234-75 package photo

Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion, 222 mL

by Crown Laboratories, Inc · 222 mL in 1 BOTTLE, PUMP (0316-0234-75)
NDC 00316-0234-75
🏷️ FDA NDC (as labeled) 0316-0234-75 billing pads the labeler segment with a zero
This package
Contains222 mL Pack sizes3 compare ↓
Also comes in: 5 ml 00316-0234-24 355 ml 00316-0234-12
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) 0316-0234-75
Product NDC 0316-0234
11-digit billing NDC 00316023475
NCPDP billing unit ML — per mL (volume)
UNII L7T10EIP3A, 88AYB867L5
Application # M017
SPL Set ID 19c41e75-a654-90cf-e063-6394a90a7e97
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-01-05
Route TOPICAL
Dosage form LOTION
Substance MENTHOL; PRAMOXINE HYDROCHLORIDE
GCN Seq No 085805
GCN 55365
HICL code 005867
Ingredient (HICL) Pramoxine Hcl/Menthol
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name SARNA CALM-COOL 1%-0.5% LOTION
FDB brand name Sarna Calm-Cool
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0316-0234-75 — a 4-4-2 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 labeler segment → 00316-0234-75. 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

LabelerCrown Laboratories, Inc
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code00316
First marketedJan 2024
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

Label name SARNA CALM-COOL 1%-0.5% LOTION Ingredient Pramoxine Hcl/Menthol
🧪 What is this product?

Sarna Pramoxine Hydrochloride and Menthol Lotion is a topical OTC product sold under FDA's monograph rules for skin-care lotions. Pramoxine hydrochloride is a local anesthetic typically used to numb minor skin irritation, while menthol is commonly included for its cooling sensation. This lotion is formulated for application directly to the skin to help relieve itching and discomfort associated with minor conditions like insect bites, eczema, or dermatitis.

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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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 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 4Q93RCW27E
    A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
  • 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 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • 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 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 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 T07U1161SV
    A plant extract from witch hazel leaves, used in medicines as a natural astringent and skin-soothing agent. It helps reduce irritation and is often included in topical formulations for its mild anti-inflammatory properties.
  • UNII 0RE8K4LNJS
    Isopropyl myristate is an oily liquid made from coconut or palm oil. It's used in medicines as an emollient and penetration enhancer to help the medicine absorb through skin or improve spreadability in topical products.
  • UNII 2V16EO95H1
    Palmitic acid is a saturated fatty acid derived from plant and animal sources. It serves as an emulsifier and lubricant in medicines, helping ingredients mix smoothly and preventing sticking during manufacturing.
  • 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 2P9L47VI5E
    A waxy compound made by combining polyethylene glycol with stearic acid. It acts as an emulsifier and thickener, helping blend oil and water-based ingredients and giving the medicine a smooth, stable consistency.
  • UNII 50C1307PZG
    Pentylene glycol is a humectant and preservative helper derived from petroleum or plant sources. It draws moisture into the product and helps prevent bacterial growth, keeping medicines stable during storage.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 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 44FQ49X6UN
    A polysaccharide (complex carbohydrate) derived from yeast cell walls. In medicines, it acts as a binder to hold tablet ingredients together and may help with tablet structure and stability.

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

The official label also statesAloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water

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: 5 ml 355 ml
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
Sarna .5 mg/1000mL; 10 mg/1000mLthis 00316-0234-75 Crown 222 ml — — FDA listed —
Gold Bond Intensive Relief Anti-Itch 1 g/100g; .5 g/100g 41167-0507-00 Chattem, 155 g — — FDA listed —
Gold Bond Medicated Anti-Itch 1 g/100g; .5 g/100g 84714-0507-00 Gold 155 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

🏛️
2024
On the market since
Jan 2024
📍
2026
Currently FDA-listed
2 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 Pramoxine Hydrochloride — the ingredient across all brands.

Top reported reactions

Product Quality Issue114
Pain89
Pruritus79
Rash78
Diarrhoea73
Nausea71
Device Delivery System Issue70

Age at onset

Child3
Adolescent1
Adult99
Elderly81

Reporter sex

1,453 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization377
Life-threatening41
Disabling19
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 130 56
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
00316-0234-12 355 mL in 1 BOTTLE, PUMP (0316-0234-12) 2024-01-05 Active
00316-0234-24 5 mL in 1 PACKET (0316-0234-24) 2024-03-13 Active
00316-0234-75 You're viewing this 222 mL in 1 BOTTLE, PUMP (0316-0234-75) 2024-01-05 Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 00316-0234-75?
NDC 00316-0234-75 contains 222 mL — 222 ml in 1 bottle, pump.
What is the difference between NDC 00316-0234-75 and NDC 00316-0234-24?
Both are Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion — the drug itself is identical. NDC 00316-0234-75 is the 222 mL package, while NDC 00316-0234-24 is the 5 ml package.
What NDC number is used to bill for this package of Sarna Pramoxine Hydrochloride, Menthol .5 mg/1000mL; 10 mg/1000mL Lotion?
Bill NDC 00316-0234-75 — the 11-digit billing format is 00316023475. 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 0316-0234-75, 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: 00316-0234-75, written without dashes as 00316023475. 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 00316-0234-75, the first segment (00316) is the labeler code FDA assigned to Crown Laboratories, Inc; the middle segment (0234) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (75) 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 Crown Laboratories, 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 2 other package presentations of this same product, including 5 ml (00316-0234-24), 355 ml (00316-0234-12). 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?
Crown Laboratories, 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 33 words ▾

Uses for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations and rashes due to poison ivy, poison oak, or poison sumac

⏱️ Dosage and Administration 42 words ▾

Directions to open, hold cap and turn pump clockwise. Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

⚠️ Warnings 96 words ▾

Warnings For external use only. Do not use in the eyes or nose over large areas of the body for prolonged periods When using this product avoid contact with the eyes. if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor. Stop use and ask a doctor if redness, irritation, swelling, or pain persists or increases.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 11 words ▾

Other information store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]

🧪 Active Ingredient 7 words ▾

Active Ingredients Menthol 0.5% Pramoxine Hydrochloride 1%

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Beta-Glucan, Butylene Glycol, C12-18 Alkanoyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Carbomer, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Isopropyl Myristate, Palmitic Acid, PEG-100 Stearate, PEG-8 Stearate, Pentylene Glycol, Sodium Hydroxide, Stearic Acid, Tocopherol, Water

🎯 Purpose 3 words ▾

Purpose External analgesic

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00316-0230-75 · Crown 00316-0255-01 · Crown →
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.