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Dibucaine Topical Anesthetic 1% Hemorrhoidal 10 mg/g Ointment — NDC 00536-1211-95 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dibucaine Topical Anesthetic 1% Hemorrhoidal 10 mg/g Ointment — NDC 0536-1211-95 (Billing 00536-1211-95)

by Rugby Laboratories Inc. · 1 TUBE in 1 BOX / 28 g in 1 TUBE

This is a package of Dibucaine Topical Anesthetic 1% Hemorrhoidal 10 mg/g Ointment from Rugby Laboratories Inc., marketed since Aug 2019 and currently FDA-listed; retail pharmacies pay about $0.1492 per g (NADAC). It is this product's only package size.

NDC 00536-1211-95
🏷️ FDA NDC (as labeled) 0536-1211-95 billing pads the labeler segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0536-1211-95
Product NDC 0536-1211
11-digit billing NDC 00536121195
NCPDP billing unit GM — per gram (weight)
RxCUI 198601
UNII L6JW2TJG99
UPC 0305361211950
Application # M015
SPL Set ID f23c8cd1-98f9-41cd-84d4-cf01c2ede29a
Established class (EPC) Standardized Chemical Allergen
Physiologic effect Increased Histamine Release; Cell-mediated Immunity
Chemical class Allergens
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-19
Route TOPICAL
Dosage form OINTMENT
Substance DIBUCAINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 90850045004205
GPI class Dibucaine
GCN Seq No 007484
GCN 30730
HICL code 002979
Ingredient (HICL) Dibucaine
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5H
Therapeutic class — specific (HIC3) Topical Local Anesthetics
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name DIBUCAINE 1% OINTMENT
FDB brand name Dibucaine
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 007484
  • GCN: 30730
  • GPI-14 (Medi-Span): 90850045004205
  • HICL (First Databank): 002979
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 198601
Why two NDCs? The FDA registers this code as 0536-1211-95 — 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 → 00536-1211-95. 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 Standardized Chemical Allergen class.

Pharmacologic class Standardized Chemical Allergen
Drug family (ATC) Local anesthetics, Anesthetics for topical use, Amides
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.

Clinical

Label name DIBUCAINE 1% OINTMENT Ingredient Dibucaine
🧪 What is this product?

This is an over-the-counter topical ointment containing dibucaine, a local anesthetic commonly used to numb pain and itching in the rectal area. Dibucaine works by blocking nerve signals that carry pain sensations to the brain. This product is marketed under FDA's OTC monograph rules for hemorrhoidal treatments and is applied directly to the affected area for temporary relief of discomfort.

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.

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 $0.149 $4.18 / 28 g
Medicaid paysCMS SDUD · 12 mo $0.2898 $8.11 / 28 g
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per g) — tap or hover for the price & month
Dec 2021 Sep 2022 Feb 2026 Sep 2026 $0.175 $0.147
▼ Down 12% over the last 20 months.
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00536-1211-95 You're viewing this Main listing 1 TUBE in 1 BOX / 28 g in 1 TUBE 2019-08-19 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dibucaine Topical Anesthetic 1% Hemorrhoidal 10 mg/gthis 00536-1211-95 Rugby 1 tube $0.149 — Availability likely —
Dibucaine 1 g/100g 57896-0131-01 Geri-Care 1 tube — — FDA listed —
CVS Topical Anesthetic Hemorrhoidal 10 mg/g 51316-0250-00 CVS 1 tube — — 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

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 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 N6K5787QVP
    Light mineral oil is a clear, odorless liquid derived from petroleum. In medicines, it acts as a lubricant and emollient to help the product spread smoothly and improve texture.
  • 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 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.

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

The official label also statesLanolin, Light Mineral Oil, Purified Water, White Petrolatum

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.

Manufacturer & labeler

LabelerRugby Laboratories Inc.
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code00536
First marketedAug 2019
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.

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 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 13 words ▾

​Use temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

⏱️ Dosage and Administration 59 words ▾

​Directions adults and children 12 years and over: If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying. apply externally to the affected area up to 3 to 4 times daily. children under 12 years of age: ask a doctor

⚠️ Warnings 140 words ▾

​Warnings ​For external use only. Allergy Alert Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use in or near the eyes in children under 2 years of age When using this product do not use more than directed 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 bleeding occurs condition worsens or does not improve within 7 days If pregnant or breast-feeding ask a health care professional before use. Keep out of reach of children. If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

🧪 Active Ingredient 7 words ▾

​Active ingredient Dibucaine 1% ​Purpose Local Anesthetic

🧪 Inactive Ingredients 9 words ▾

undefined Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

🎯 Purpose 3 words ▾

​Purpose Local Anesthetic

📄 Do Not Use 15 words ▾

Do not use in or near the eyes in children under 2 years of age

📄 When Using This Product 32 words ▾

When using this product do not use more than directed 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 18 words ▾

Stop use and ask a doctor if bleeding occurs condition worsens or does not improve within 7 days

🤰 If Pregnant or Breast-Feeding 11 words ▾

If pregnant or breast-feeding ask a health care professional before use.

📄 Keep Out of Reach of Children 20 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a poison control center (1-800-222-1222) right away.

📄 Questions or Comments 5 words ▾

Questions or comments? call 1-800-639-3803

📄 Package Label / Principal Display Panel 3 words ▾

Package Labeling: Label

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
925
Units reimbursed last 4 qtrs
18K
Gross reimbursed last 4 qtrs
$5.2K
Avg / prescription
$5.65
Avg / unit
$0.2898
Latest quarter Q1 2026
198Rx
Medicaid pays / g
$0.2898
gross reimbursed
vs
NADAC / g
$0.1492
acquisition cost
=
Spread
+$0.1406
+94% vs cost
What Medicaid paid per g (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
20% FFS 80% MCO
Fee-for-service · 189 Rx Managed care · 736 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 364 units · 6.3 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: no data reported NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 2,016 units · 16.1 per 100k residents IL Indiana: 7,409 units · 108 per 100k residents IN Ohio: 4,460 units · 37.8 per 100k residents OH Pennsylvania: 1,716 units · 13.2 per 100k residents PA New Jersey: 392 units · 4.2 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,680 units · 5.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2108
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Indiana 108 /100k
2 Ohio 37.8 /100k
3 Illinois 16.1 /100k
4 Pennsylvania 13.2 /100k
5 Minnesota 6.3 /100k
6 Texas 5.5 /100k
7 New Jersey 4.2 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

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 Dibucaine Topical Anesthetic 1% Hemorrhoidal (this brand).

Top reported reactions

Back Pain19
Malaise18
Nausea16
Blood Pressure Increased15
Crohn^s Disease15
Anxiety14
Blood Pressure Systolic Increased14

Age at onset

Adolescent1
Adult15
Elderly6

Reporter sex

114 reports
Male · 46%
Female · 54%

Serious outcomes

Hospitalization49
Death6
Life-threatening3
Disabling3
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 19 2
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.
← 00536-1206-10 · RUGBY 00536-1213-88 · Rugby →
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.