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Bunnies Bum Soothing Hemorrhoidal Glycerin, Lidocaine, Petrolatum, Phenylephrine HCl 14.4 g/100g; 15 g/100g; .25 g/100g; 5 g/100g Cream, 57 g

by FloCal Distributors LLC · 57 g in 1 TUBE (84308-161-02)
NDC 84308-0161-02
🏷️ FDA NDC (as labeled) 84308-161-02 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 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) 84308-161-02
Product NDC 84308-161
11-digit billing NDC 84308016102
RxCUI 2642220
UNII PDC6A3C0OX, 4T6H12BN9U, 04JA59TNSJ, 98PI200987
Application # M015
SPL Set ID 1c81582c-7ece-182f-e063-6294a90a8fbc
Established class (EPC) Non-Standardized Chemical Allergen; Amide Local Anesthetic; Antiarrhythmic
Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production; Local Anesthesia
Chemical class Allergens; Glycerol; Amides
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-07-08
Route TOPICAL
Dosage form CREAM
Substance GLYCERIN; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE; LIDOCAINE
Why two NDCs? The FDA registers this code as 84308-161-02 — 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 → 84308-0161-02. 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 Non-Standardized Chemical Allergen class.

Pharmacologic class Non-Standardized Chemical Allergen
Drug family (ATC) Enemas, Other drugs for constipation
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

LabelerFloCal Distributors LLC
FDA applicationM015 (OTC MONOGRAPH DRUG)
Labeler code84308
First marketedJul 2024
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's OTC monograph rules for hemorrhoidal products. It contains glycerin and petrolatum, which are typically used as moisturizing and protective ingredients, along with lidocaine, a local anesthetic commonly used to numb minor pain and itching. Phenylephrine hydrochloride functions as a decongestant and is typically included to reduce swelling in hemorrhoidal tissues. The product is applied directly to the affected area.

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 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 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 5SL0G7R0OK
    A simple sugar made from corn or other plants, used in medicines as a filler and sweetener. It helps create the right texture and taste in tablets, powders, and liquid formulations.
  • UNII PQ6CK8PD0R
    Ascorbic acid, also known as vitamin C, is a white crystalline powder. It serves as an antioxidant to prevent degradation of other ingredients and may also function as a preservative in the formulation.
  • UNII CUQ3A77YXI
    Panax ginseng root is a plant extract traditionally used in herbal preparations. In medications, it may serve as an active botanical ingredient or be included for flavoring and as a natural preservative or binder in formulations.
  • UNII U182GP2CF3
    Bromelain is an enzyme derived from pineapple plants that breaks down proteins. In medications, it acts as a disintegrant, helping tablets or capsules break apart and release their active ingredients more quickly in the digestive system.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • 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 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 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 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 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 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 4PW41QCO2M
    Indian frankincense is a natural resin extracted from trees native to India. It is used in medicines as a binder and thickening agent to help hold ingredients together and improve texture.
  • UNII T5L8T28FGP
    Mineral oil is a clear, odorless liquid derived from crude oil. It acts as a lubricant and emollient in medications, helping pills slide smoothly during manufacturing and aiding moisture retention 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 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 8D4SNN7V92
    Propyl gallate is a synthetic antioxidant derived from gallic acid. It prevents oils and fats in the medicine from oxidizing and spoiling, helping the product stay stable and effective during storage.
  • 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 205MXS71H7
    A plant extract from white willow bark. It's used as a natural flavoring agent and may help preserve the medicine by providing mild antioxidant properties in the formulation.
  • UNII MDL271E3GR
    Sorbitan olivate is an emulsifier derived from sorbitol and olive oil. It helps blend water and oil ingredients together to maintain consistent texture and appearance throughout the medicine.
  • UNII 53J3F32P58
    A synthetic detergent derived from stearic acid, a fatty substance. It helps dissolve or distribute oil-based ingredients evenly throughout the medicine, acting as an emulsifier and solubilizer in tablets and capsules.
  • UNII 2KR89I4H1Y
    Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
  • 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 856YO1Z64F
    Turmeric is a natural spice derived from the turmeric plant root. It serves as a colorant in medicines, giving products a yellow or golden appearance, and may also provide mild flavoring.
  • 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesAloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

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
Walgreens Hemorrhoidal Pain Relief 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 00363-1217-01 Walgreens 28 g — — FDA listed —
Preparation H Rapid Relief 150 mg/g; 2.5 mg/g; 144 mg/g; 50 mg/g 00573-2843-01 Haleon 1 tube — — FDA listed —
Kroger Hemorrhoid 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 30142-0713-01 Kroger 12 tubes — — FDA listed —
GoodSense Hemorrhoidal Pain Relief 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 50804-0317-01 Perrigo 1 tube — — FDA listed —
Hemorrhoidal With Lidocaine 144 mg/g; 50 mg/g; 2.5 mg/g; 150 mg/g 51316-0225-00 CVS 1 tube — — FDA listed —
Hemorrhoidal Cream with Lidocaine 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 69396-0181-01 Trifecta 1 tube — — FDA listed —
Curist Hemorrhoid Fissure Relief 15 g/100g; 5 g/100g; 14.4 g/100g; .25 g/100g 72559-0037-08 Little 170 g — — FDA listed —
DCH Hemorrhoidal 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 72839-0217-01 Derma 1 tube — — FDA listed —
Revivol Hemorrhoid and Fissure 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 72839-0295-01 Derma 1 tube — — FDA listed —
Bunnies Bum Soothing Hemorrhoidal 14.4 g/100g; 15 g/100g; .25 g/100g; 5 g/100gthis 84308-0161-02 FloCal 57 g — — FDA listed —
ElixirLidoFast Rapid Relief 150 mg/g; 2.5 mg/g; 144 mg/g; 50 mg/g 84546-0006-01 ELIXIR 1 tube — — FDA listed —
Dermatool Hemorrhoidal 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 84728-0413-01 Papalo 1 tube — — FDA listed —
Norms Hemorrhoid 5 g/100g; 15 g/100g; 14.4 g/100g; .25 g/100g 85996-0173-00 Totally 5 pouches — — 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
Jul 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
84308-0161-02 You're viewing this 57 g in 1 TUBE (84308-161-02) 2024-07-08 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 — Not published for this NDC No photo available yet for this listing.
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 84308-161-02, 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: 84308-0161-02, written without dashes as 84308016102. 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 84308-0161-02, the first segment (84308) is the labeler code FDA assigned to FloCal Distributors LLC; the middle segment (0161) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 FloCal Distributors LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FloCal Distributors 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 47 words ▾

For the temporary relief of pain, soreness, and burning Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue Temporarily provides a costing for the relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

⏱️ Dosage and Administration 67 words ▾

Adults: when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 4 times a day, especially at night, in the morning, or after each bowel movement. Children under 12 years of age: consult a doctor.

⚠️ Warnings 139 words ▾

For external use only. 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 avoid contact with eyes do not exceed recommended dosage unless directed by a doctor do not put this into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if rectal bleeding occurs condition worsens or does not improve within 7 days allergic reaction occurs to ingredients in this product symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase symptoms clear up and return within a few days

🧪 Active Ingredient 9 words ▾

Glycerin 14.4%, Lidocaine 5%, Petrolatum 15%, Phenylephrine HCl 0.25%

🧪 Inactive Ingredients 56 words ▾

Aloe barbadensis leaf extract, ascorbic acid, BHT, boswellia serrata extract, bromelain, cellulose gum, cetyl alcohol, citric acid, curcuma long (turmeric) root extract, disodium EDTA, ethylhexylglycerin, glucose, glyceryl stearate, mineral oil, panax ginseng root extract, panthenol, phenoxyethanol, propyl gallate, propylene glycol, salix alba (willow) bark extract, sorbitan olivate, steareth-21, stearyl alcohol, tocopherol, tocopheryl acetate, water, xanthan gum.

🎯 Purpose 7 words ▾

Glycerin-Protectant Lidocaine-Local anesthetic Petrolatum-Protectant Phenylephrine HCl Vasoconstrictor

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 84308-0159-01 · FloCal 84308-0173-05 · FloCal →
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.