NDC 84313-0101-15 — tina davies IceJelly Hemorrhoidal Lidocaine

🆔 Identity & classification

FDA NDC (as labeled) 84313-101-15

Product NDC 84313-101

11-digit billing NDC 84313010115

RxCUI 1314136

UNII 98PI200987, 04JA59TNSJ

UPC 0840058825275

Application # M015

SPL Set ID 580559bf-d91f-4bb3-9c9b-b7e2cd0686fd

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 2026-06-11

Route TOPICAL

Dosage form CREAM

Substance LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 84313-101-15 — 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 → 84313-0101-15. 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

🔎 All NDCs from TINA DAVIES PROFESSIONAL LLC

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?

Tina Davies IceJelly Hemorrhoidal is a topical cream marketed under FDA's over-the-counter monograph rules for hemorrhoid products. It contains lidocaine, a local anesthetic typically used to numb pain and itching in the affected area, and phenylephrine hydrochloride, a decongestant that functions to reduce swelling and shrink blood vessels. This combination is commonly used to provide temporary relief of hemorrhoid symptoms when applied directly to the skin.

Patient education

📘 MedlinePlus patient leaflet ↗

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 A9U1687S1S
A naturally occurring amino acid salt used as a reducing agent and antioxidant. It helps stabilize the medicine by preventing unwanted chemical reactions and maintaining the product's shelf life and potency.
UNII 9DBA0SBB0L
A synthetic red dye derived from coal tar used as a colorant in medicines and cosmetics. It gives tablets, capsules, and liquids their red or pink appearance for identification and visual appeal.
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 T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
UNII WV9CM0O67Z
Panthenol is a humectant and skin-conditioning agent derived from pantothenic acid. It's added to medicines to help retain moisture and soothe skin irritation.
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 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.

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

The official label also statesD&C Red No. 33, Disodium EDTA, Glycerin, Hydroxyethylcellulose, L-Cysteine HCl, Panthenol, Phenoxyethanol, Purified 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 system	Per g	Per 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

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price 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/100mL 84313-0002-15	TINA	1 tube	—	—	FDA listed	—
tina davies IceJelly Hemorrhoidal 5 g/100mL; .25 g/100mLthis 84313-0101-15	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.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
84313-0101-30	1 TUBE in 1 BOX (84313-101-30) / 30 mL in 1 TUBE	2026-06-11	Active
84313-0101-15 You're viewing this	1 TUBE in 1 BOX (84313-101-15) / 15 mL in 1 TUBE	2026-07-01	Active

Pack size FAQ

What quantity is in NDC 84313-0101-15?

NDC 84313-0101-15 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 IceJelly Hemorrhoidal Lidocaine, Phenylephrine Hydrochloride 5 g/100mL; .25 g/100mL Cream?

Bill NDC 84313-0101-15 — the 11-digit billing format is 84313010115. 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 84313-101-15, 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: 84313-0101-15, written without dashes as 84313010115. 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 84313-0101-15, the first segment (84313) is the labeler code FDA assigned to TINA DAVIES PROFESSIONAL LLC; the middle segment (0101) 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 1 other package presentation of this same product, including 1 tube (84313-0101-30). 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 40 words ▾

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

⏱️ Dosage and Administration 58 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: ask a doctor.

⚠️ Warnings 193 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. • in case of bleeding, consult a doctor promptly. Stop use and ask a doctor if • condition worsens or does not improve within 7 days. • an allergic reaction develops. If pregnant or breast-feeding, ask a health professional before use.

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

📦 Storage and Handling 21 words ▾

Other information • store at 20–25°C (68–77°F). • protect from light. • do not use if seal is broken or missing.

🧪 Active Ingredient 9 words ▾

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

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients D&C Red No. 33, Disodium EDTA, Glycerin, Hydroxyethylcellulose, L-Cysteine HCl, Panthenol, Phenoxyethanol, Purified Water.

🎯 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 ↗

🔗 Related NDC lookups

🧪 All Lidocaine, Phenylephrine Hydrochloride NDCsSame ingredient 🏭 All TINA labeler NDCsLabeler code 84313 📚 All Amide Local Anesthetic NDCsDrug class