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tina davies IceCream Hemorrhoidal Lidocaine, Phenylephrine Hydrochloride 5 g/100mL; .25 g/100mL Cream — NDC 84313-0002-15 package photo

tina davies IceCream Hemorrhoidal Lidocaine, Phenylephrine Hydrochloride 5 g/100mL; .25 g/100mL Cream

by TINA DAVIES PROFESSIONAL LLC · 1 TUBE in 1 BOX (84313-002-15) / 15 mL in 1 TUBE
NDC 84313-0002-15
🏷️ FDA NDC (as labeled) 84313-002-15 billing pads the product segment with a zero
This package
Contains15 mL in 1 tube Pack sizes3 compare ↓
Also comes in: 30 mL 84313-0002-30 5 ml 84313-0002-05
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) 84313-002-15
Product NDC 84313-002
11-digit billing NDC 84313000215
RxCUI 1314136
UNII 98PI200987, 04JA59TNSJ
Application # M015
SPL Set ID 10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd
Established class (EPC) Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Local Anesthesia
Chemical class Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-08
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 84313-002-15 — 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 → 84313-0002-15. 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 Antiarrhythmic class.

Pharmacologic class Antiarrhythmic, Amide Local Anesthetic
Drug family (ATC) Antiarrhythmics, class Ib, Local anesthetics, Anesthetics for topical use
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.

🏭 Manufacturer & labeler

LabelerTINA DAVIES PROFESSIONAL LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code84313
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio3 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

🧪 What is this product?

This is an over-the-counter topical cream marketed under FDA monograph rules for hemorrhoidal use. It contains lidocaine, a local anesthetic that is typically used to numb pain and itching in the area where it is applied, and phenylephrine hydrochloride, a decongestant that is commonly used to reduce swelling and shrink blood vessels in hemorrhoidal tissue. The cream is meant to be applied directly to the affected area to help relieve discomfort associated with hemorrhoids.

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 L4EL31FWIL
    A synthetic peptide (short chain of amino acids) used as a conditioning or texture-enhancing agent in topical formulations. It helps improve product feel and skin compatibility in creams and lotions.
  • 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 E4F12ROE70
    A refined mineral oil derived from crude petroleum containing 13 to 14 carbon chains. It acts as a solvent, emollient, and carrier in topical formulations to help dissolve active ingredients and improve product texture and spreadability.
  • UNII K679OBS311
    Carboxymethylcellulose sodium is a plant-derived thickening agent made from cellulose. In medicines, it acts as a binder to hold ingredients together, a disintegrant to help the tablet break apart, or a thickener in liquids.
  • UNII 0F32U78V2Q
    Chloroxylenol is a synthetic antimicrobial chemical used as a preservative in medicines and personal care products. It prevents bacterial and fungal growth to help keep the medication safe and effective during storage.
  • 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 YSE9PPT4TH
    Hyaluronate sodium is a natural carbohydrate that holds moisture. It's used in medicines as a lubricant, thickener, and moisture-retaining agent to improve texture and delivery of the active ingredient.
  • UNII Z95S6G8201
    A synthetic surfactant derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oily and watery ingredients in liquid formulations, and may improve how the medicine spreads or is absorbed.
  • UNII PO4D55T1IG
    A synthetic peptide made of five amino acids linked together. It is used in skincare and cosmetic formulations as an active conditioning agent to help improve skin texture and appearance.
  • 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 E2KR9C9V2I
    Polyacrylamide is a synthetic polymer used as a thickening agent and binder in medications. It helps create the proper texture and hold ingredients together in the formulation.
  • 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.

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

The official label also statesAcetyl Hexapeptide-8, Butylene Glycol, C13-14 Isoparaffin, Carboxymethylcellulose Sodium, Chloroxylenol, Ethylhexylglycerin, 1,2-Hexanediol, Laureth-7, Pentapeptide-18, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Hyaluronate, Water (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.

💲 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: 30 mL 5 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
Liposomal Hemorrhoid Master 5 g/100g; .25 g/100g 63742-0038-01 Clinical 1 tube — — FDA listed —
Hemorrohoid Master Cream 50 mg/g; 2.5 mg/g 72654-0038-01 Ebanel 45 g — — FDA listed —
Hemorrhoid and Fissure Cream with Lidocaine 5% plus Phenylephrine HCL 0.25% 5 g/100g; .25 g/100g 73715-0007-01 Mohnark 30 g — — Discontinued —
tina davies IceCream Hemorrhoidal 5 g/100mL; .25 g/100mLthis 84313-0002-15 TINA 1 tube — — FDA listed —
tina davies IceJelly Hemorrhoidal 5 g/100mL; .25 g/100mL 84313-0101-30 TINA 1 tube — — FDA listed —
Treatonic hemorrhoid treatment 2.5 g/50g; .125 g/50g 85569-0008-01 100 50 g — — Discontinued —
Terramed Just Think Comfort Hemorrhoidal Wipes 5 g/100mL; .25 g/100mL 83004-0039-01 Rida 25 patches — — 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

🏛️
2026
On the market since
Jun 2026
📍
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.

🔬 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 Lidocaine, Phenylephrine Hydrochloride — the ingredient across all brands.

Top reported reactions

Haemorrhage4
Burning Sensation3
Diarrhoea2
Drug Hypersensitivity2
Fatigue2
Haemorrhoids2
Pain2

Reporter sex

17 reports
Male · 13%
Female · 87%

Serious outcomes

Hospitalization6
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 8 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84313-0002-15 You're viewing this 1 TUBE in 1 BOX (84313-002-15) / 15 mL in 1 TUBE 2026-06-08 Active
84313-0002-05 5 mL in 1 TUBE (84313-002-05) 2026-06-17 Active
84313-0002-30 1 TUBE in 1 BOX (84313-002-30) / 30 mL in 1 TUBE 2026-06-17 Active

Pack size FAQ

What quantity is in NDC 84313-0002-15?
NDC 84313-0002-15 is listed by the FDA — 1 tube in 1 box / 15 ml in 1 tube.
What NDC number is used to bill for this package of tina davies IceCream Hemorrhoidal Lidocaine, Phenylephrine Hydrochloride 5 g/100mL; .25 g/100mL Cream?
Bill NDC 84313-0002-15 — the 11-digit billing format is 84313000215. 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 84313-002-15, 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: 84313-0002-15, written without dashes as 84313000215. 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 84313-0002-15, the first segment (84313) is the labeler code FDA assigned to TINA DAVIES PROFESSIONAL LLC; the middle segment (0002) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) 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 TINA DAVIES PROFESSIONAL LLC. 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 1 tube (84313-0002-30), 5 ml (84313-0002-05). 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?
TINA DAVIES PROFESSIONAL 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 36 words ▾

Uses for the temporary relief of anorectal itching and discomfort associated with hemorrhoids for the temporary relief of pain temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders temporarily shrinks hemorrhoidal tissue

⏱️ Dosage and Administration 55 words ▾

Directions adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. apply externally to the affected area up to 4 times daily. children under 12 years of age: consult a doctor.

⚠️ Warnings 163 words ▾

Warnings For external use only Allergy alert: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor. Ask a doctor before use if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

When using this product do not exceed the recommended daily 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 condition worsens or does not improve within 7 days in case of bleeding Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 13 words ▾

Other information store in cool, dry place away from moisture and direct light

🧪 Active Ingredient 9 words ▾

Active ingredients Lidocaine 5% w/v Phenylephrine HCl 0.25% w/v

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients Acetyl Hexapeptide-8, Butylene Glycol, C13-14 Isoparaffin, Carboxymethylcellulose Sodium, Chloroxylenol, Ethylhexylglycerin, 1,2-Hexanediol, Laureth-7, Pentapeptide-18, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Hyaluronate, Water (Aqua).

🎯 Purpose 4 words ▾

Purposes Local anesthetic Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84313-0001-05 · TINA 84313-0101-30 · TINA →
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.