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Flarestop Hemorrhoid Lidocaine 50 mg/g Cream — NDC 87989-0013-00 package photo

Flarestop Hemorrhoid Lidocaine 50 mg/g Cream

by Chelsea Pharmacceuticals LLC · 1 TUBE in 1 CARTON (87989-013-00) / 57 g in 1 TUBE
NDC 87989-0013-00
🏷️ FDA NDC (as labeled) 87989-013-00 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

⚠️
Other active recalls for Lidocaine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class III · Apr 20, 2023 — Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains. (Bryant Ranch Prepack, Inc.) · FDA recall D-0556-2023
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 87989-013-00
Product NDC 87989-013
11-digit billing NDC 87989001300
UNII 98PI200987
UPC 0884400715227
Application # M015
SPL Set ID b8a589f7-7131-4807-9bcb-84af3078e258
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 2026-09-07
Route TOPICAL
Dosage form CREAM
Substance LIDOCAINE
Why two NDCs? The FDA registers this code as 87989-013-00 — 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 → 87989-0013-00. 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

LabelerChelsea Pharmacceuticals LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code87989
First marketedSep 2026
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
  • It's best to avoid using two lidocaine products at the same time unless your doctor says it's okay. When you use multiple products containing a local anesthetic, the total amount a...
  • Can I use a lidocaine patch and a lidocaine cream at the same time?
  • No — please don't do this. Heat significantly increases how much lidocaine is absorbed through your skin, which can push drug levels in your blood higher than they should be. Stick...
  • Can I put a heating pad on the area where I applied a lidocaine patch?
📖 Read our full Lidocaine 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 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 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 A9EJ3J61HQ
    A synthetic liquid derived from benzoic acid and long-chain alcohols. It functions as a solvent and penetration enhancer in topical formulations, helping active ingredients dissolve and absorb into the skin.
  • 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 RUE8E6T4NB
    Aloe vera leaf juice is a clear gel extracted from aloe vera plant leaves. It's used in medicines as a lubricant, emollient, and preservative to soothe skin contact and help keep the product stable.
  • UNII Q7UI015FF9
    A synthetic polymer material used as a thickener and stabilizer in liquid formulations. It helps create the right texture and prevents separation of ingredients in medicines and topical products.
  • UNII 24WE03BX2T
    Levomenol is a naturally derived alcohol compound used as a skin-conditioning and anti-inflammatory agent in topical formulations. It helps soothe and protect the skin while improving product texture and absorption.
  • 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 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 A1A1I8X02B
    A clear liquid solvent derived from ethylene glycol. It helps dissolve active ingredients and improve how the medicine flows and mixes in liquid formulations.
  • 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 WH8T92A065
    A fatty acid derivative made by combining stearic acid with glycerin and citric acid. It acts as an emulsifier to help mix oil and water-based ingredients, and also serves as a thickener in the medicine formulation.
  • UNII 2788Z9758H
    A plant extract from licorice root used as a sweetener, flavoring agent, and natural emulsifier in medicines. It helps improve taste and may aid in keeping ingredients evenly mixed throughout the product.
  • 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 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 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 88496G1ERL
    Sodium phytate is a plant-derived salt used in medications as a chelating agent and preservative. It helps stabilize formulations and may improve how the body absorbs certain minerals in the medicine.
  • UNII K49155WL9Y
    Shea butter is a fat extracted from shea tree nuts. It's used in medicines as an emollient and lubricant to soften the product, improve texture, and help ingredients blend smoothly together.
  • 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 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.

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

The official label also statesAllantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Dimethicone, Ethoxydiglycol, Glycerin, Glyceryl Stearate Citrate, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Isopropyl Myristate, Panthenol, Pentylene Glycol, Polyacrylate Crosspolymer-6, Sodium Hyaluronate, Sodium Phytate, Tocopheryl Acetate, 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.
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
Lidocaine 50 mg/g 51672-3008-03 Sun 50 g $0.144 AT Discontinued —
Lidocaine 50 mg/g 64380-0789-23 Strides 30 g $0.158 AT Discontinued —
Lidocaine 50 mg/g 62332-0424-30 Alembic 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 33342-0405-30 Macleods 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 51672-3020-02 Sun 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 68462-0418-20 Glenmark 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 70752-0113-03 QUAGEN 1 tube $0.161 AT Availability likely —
Lidocaine 50 mg/g 00168-0204-37 Fougera 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 16714-0878-01 Northstar 1 tube $0.161 AT Availability likely —
lidocaine 50 mg/g 75834-0333-30 Nivagen 30 g $0.394 — Availability likely —
Leader Maximum Strength Hemorrhoidal Relief 50 mg/g 70000-0650-01 Cardinal 1 tube $0.394 — Availability likely —
Lidocaine 50 mg/g 71205-0288-50 Proficient 1 jar — AT FDA listed —
Lidocaine 50 mg/g 71205-0342-44 Proficient 1 tube — AT FDA listed —
lidocaine 50 mg/g 71205-0500-44 Proficient 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71205-0549-44 Proficient 35.44 g — AT FDA listed —
lidocaine 50 mg/g 71205-0717-50 Proficient 50 g — AT FDA listed —
lidocaine 50 mg/g 76420-0125-50 Asclemed 50 g — AT FDA listed —
Lidocaine 50 mg/g 76420-0131-50 Asclemed 50 g — AT FDA listed —
Maximum Strength Hemorrhoidal Relief 50 mg/g 51316-0226-00 CVS 1 tube — — FDA listed —
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger Cots 50 mg/g 51316-0229-00 CVS 1 tube — — FDA listed —
Lidocaine 50 mg/g 63629-2503-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-2504-01 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 63629-8848-01 Bryant 1 tube — AT FDA listed —
Microcaine Topical Analgesic 50 mg/g 67194-0022-01 Unit 15 g — — FDA listed —
Lidocaine 50 mg/g 71205-0814-44 Proficient 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72162-2084-02 Bryant 1 tube — AT FDA listed —
lidocaine 50 mg/g 76420-0550-35 Asclemed 1 tube — AT FDA listed —
DR REAL NUMB Topical Anorectal 50 mg/g 83800-0430-00 FUZZYLULU 1 tube — — FDA listed —
Lidocaine 50 mg/g 80425-0509-01 Advanced 1 tube — AT FDA listed —
lidocaine 50 mg/g 85509-1418-03 PHOENIX 1 tube — AT FDA listed —
Lidocaine 50 mg/g 85509-1918-01 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 68788-7376-03 Preferred 1 tube — AT FDA listed —
RectaEase Hemorrhoid Relief Cream 50 mg/g 69396-0070-01 Trifecta 1 tube — — FDA listed —
Lidocaine 50 mg/g 72189-0168-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0248-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0538-01 Advanced 1 jar — AT FDA listed —
Lidocaine 50 mg/g 87063-0144-50 Asclemed 1 tube — AT FDA listed —
Numb520 50 mg/g 63742-0033-01 Clinical 1 bottle — — FDA listed —
lidocaine 50 mg/g 70518-3902-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0165-35 DIRECT 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0493-35 Direct_Rx 35.44 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0499-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 80425-0247-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 83008-0067-50 Quality 50 g — AT FDA listed —
Lidocaine 50 mg/g 68071-3792-05 NuCare 1 jar — AT FDA listed —
Lidocaine 50 mg/g 70518-3746-00 REMEDYREPACK 1 tube — AT FDA listed —
Numb 520 50 mg/g 72654-0033-02 Ebanel 125 g — — FDA listed —
PUREGEN LABS Maximum Strength Lidocaine 50 mg/g 80513-0813-06 Advanced 170 g — — FDA listed —
Lidocaine 50 mg/g 83008-0044-50 Quality 1 jar — AT FDA listed —
Lidocaine 50 mg/g 85509-1424-05 PHOENIX 50 g — AT FDA listed —
Lidocaine 50 mg/g 59651-0591-30 Aurobindo 1 tube — AT FDA listed —
Lidocaine 50 mg/g 65162-0918-41 Amneal 150 g — AT FDA listed —
Lidocaine 50 mg/g 68788-7766-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 72162-2068-02 Bryant 1 tube — AT FDA listed —
Lidocaine 50 mg/g 51407-0383-35 Golden 1 tube — AT FDA listed —
Numb Master 50 mg/g 63742-0032-01 Clinical 1 bottle — — FDA listed —
Numb25 50 mg/g 63742-0035-01 Clinical 38 g — — FDA listed —
lidocaine 50 mg/g 68788-8396-05 Preferred 50 g — AT FDA listed —
Lidocaine 50 mg/g 70518-4192-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0488-50 Direct_Rx 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0601-35 Direct_rx 35 g — AT FDA listed —
Recticare 50 mg/g 00496-0892-15 Ferndale 15 g — — FDA listed —
lidocaine 50 mg/g 80425-0450-01 Advanced 1 tube — AT FDA listed —
Lidocaine 50 mg/g 17856-3008-01 ATLANTIC 120 syringes — AT FDA listed —
Numb25 50 mg/g 72654-0036-02 Ebanel 125 g — — FDA listed —
lidocaine 50 mg/g 50090-7922-00 A-S 1 tube — AT FDA listed —
Lidocaine 50 mg/g 71335-2856-01 Bryant 1 tube — AT FDA listed —
Lmx5 50 mg/g 00496-0883-15 Ferndale 15 g — — FDA listed —
Lidocaine 50 mg/g 80425-0442-01 Advanced 50 g — AT FDA listed —
lidocaine 50 mg/g 80425-0554-01 Advanced 50 g — AT FDA listed —
Lidocaine 50 mg/g 71205-0429-30 Proficient 1 tube — AT FDA listed —
HemRid Anorectal Cream 50 mg/g 82620-0001-01 KKA 1 tube — — FDA listed —
Lidocaine 50 mg/g 85509-3008-05 PHOENIX 1 jar — AT FDA listed —
Lidocaine 50 mg/g 58980-0823-30 STRATUS 1 tube — — FDA listed —
Quick Numb 50 mg/g 63742-0333-01 Clinical 35.43 g — — FDA listed —
Lidocaine 50 mg/g 80425-0324-01 Advanced 1 tube — AT FDA listed —
Lidocaine 5% Cream 50 mg/g 82461-0420-30 Medcore 1 tube — — FDA listed —
Dr. Care Numbing Cream 50 mg/g 84019-0038-01 Shengnan 30 g — — FDA listed —
Lidocaine 50 mg/g 46708-0424-30 Alembic 1 tube — AT FDA listed —
Lidocaine 50 mg/g 68788-4050-05 Preferred 1 jar — AT FDA listed —
lidocaine 50 mg/g 70518-3972-00 REMEDYREPACK 50 g — AT FDA listed —
Lidocaine 50 mg/g 72189-0211-50 DIRECT 50 g — AT FDA listed —
Equate Hemorrhoid Relief 50 mg/g 79903-0428-01 Walmart 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8011-00 A-S 1 tube — AT FDA listed —
Lidocaine Cream 50 mg/g 71457-0525-15 InvaDerm 1 tube — — FDA listed —
Lidocaine 50 mg/g 50090-8040-00 A-S 1 tube — AT FDA listed —
Flarestop Hemorrhoid Lidocaine 50 mg/gthis 87989-0013-00 Chelsea 1 tube — — FDA listed —
Lidocaine 50 mg/g 80425-0594-01 Advanced 1 tube — AT 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
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Lidocaine (matched by generic name) — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Lidocaine. CMS lists 8 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$53.12M
Claims incl. refills
593.7K
Beneficiaries
367.9K
Spend / beneficiary
$144.39
Spend / claim
$89.46
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87989-0013-00 You're viewing this 1 TUBE in 1 CARTON (87989-013-00) / 57 g in 1 TUBE 2026-09-07 Active

🧭 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 87989-013-00, 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: 87989-0013-00, written without dashes as 87989001300. 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 87989-0013-00, the first segment (87989) is the labeler code FDA assigned to Chelsea Pharmacceuticals LLC; the middle segment (0013) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (00) 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 Chelsea Pharmacceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chelsea Pharmacceuticals 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 21 words ▾

Uses Helps relieve the local itching and discomfort in the perianal area. For the temporary relief of pain, irritation or burning.

⏱️ Dosage and Administration 63 words ▾

Directions Adults: When practical, cleanse the affected area with mild soap and warm water and rinse by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor. Apply externally to the affected area up to 6 times daily.

⚠️ Warnings 128 words ▾

Warnings For external use only Do Not Exceed the recommended daily dosage unless directed by a doctor. put this product into the rectum by using your fingers or any mechanical device or applicator. When using this product If the condition worsens or does not improve within 7 days, consult a doctor. In case of bleeding, consult a doctor promptly.

Stop use and ask a doctor if If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase. Allergy alert Certain persons can develop allergic reactions to ingredients in this product. Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 9 words ▾

Active ingredients Lidocaine 5.00 % Purpose Local Anesthetic (anorectal)

🧪 Inactive Ingredients 48 words ▾

Inactive ingredients Allantoin, Aloe Barbadensis Leaf Juice, Bisabolol, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetearyl Alcohol, Citric Acid, Dimethicone, Ethoxydiglycol, Glycerin, Glyceryl Stearate Citrate, Glycyrrhiza Glabra (Licorice) Root Extract, 1,2-Hexanediol, Isopropyl Myristate, Panthenol, Pentylene Glycol, Polyacrylate Crosspolymer-6, Sodium Hyaluronate, Sodium Phytate, Tocopheryl Acetate, Water (Aqua).

🎯 Purpose 4 words ▾

Purpose Local Anesthetic (anorectal)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 87986-0001-01 · HONG 87992-0001-01 · Sent →
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.