HomeNDC LookupIngredientsBenzocaine, Resorcinol › 55621-0016-01
Family Wellness BENZOCAINE, RESORCINOL 20 g/100g; 3 g/100g Cream — NDC 55621-0016-01 package photo

Family Wellness BENZOCAINE, RESORCINOL 20 g/100g; 3 g/100g Cream

by Zhejiang Jingwei Pharmaceutic Al Co., Ltd. · 1 TUBE in 1 CARTON (55621-016-01) / 28 g in 1 TUBE
NDC 55621-0016-01
🏷️ FDA NDC (as labeled) 55621-016-01 billing pads the product segment with a zero
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 →

🆔 Identity & classification

FDA NDC (as labeled) 55621-016-01
Product NDC 55621-016
11-digit billing NDC 55621001601
RxCUI 637518
UNII U3RSY48JW5, YUL4LO94HK
Application # M017
SPL Set ID df540eb8-6773-4647-9cc2-c3fd14d7355e
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 2017-08-20
Route TOPICAL
Dosage form CREAM
Substance BENZOCAINE; RESORCINOL
Why two NDCs? The FDA registers this code as 55621-016-01 — 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 → 55621-0016-01. 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, Esters of aminobenzoic acid
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

LabelerZhejiang Jingwei Pharmaceutic Al Co., Ltd.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code55621
First marketedAug 2017
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 containing benzocaine and resorcinol, marketed under FDA's monograph rules for its category. Benzocaine is a local anesthetic commonly used to numb skin and reduce pain or itching on contact, while resorcinol is typically used as an antimicrobial and keratolytic agent. Together, these ingredients are commonly included in topical products intended to soothe minor skin irritation and discomfort.

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 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 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 1C6V77QF41
    Cholecalciferol is vitamin D3, a fat-soluble vitamin added to medicines as a nutritional supplement or active ingredient fortification. It helps the body absorb calcium and support bone health.
  • UNII 9G34HU7RV0
    EDTA is a chemical compound that binds to metals and other substances in medicines. It's used as a preservative and stabilizer to prevent discoloration and extend 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 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 8CRQ2TH63M
    Isopropyl palmitate is an oily liquid derived from palm oil. It acts as an emollient and lubricant in medicines, helping soften the skin or improve how the product spreads and flows.
  • 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 A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • 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 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 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 G2SH0XKK91
    Retinol is a form of vitamin A derived from animal sources or synthesized in a lab. In medicines, it may serve as an active therapeutic ingredient in some formulations, though when listed as an excipient it functions as a skin-conditioning agent or antioxidant to help stabilize the product.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 0YPR65R21J
    Sodium sulfate is a mineral salt used in pharmaceuticals as a filler and diluent. It helps provide bulk and stability to tablets and capsules while remaining inert in the body.
  • 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 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.

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

The official label also statesInactive ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Cholecalciferol, EDTA, Fragrance, Glyceryl stearate, Isopropyl myristate, Isopropyl palmitate, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylene glycol, Retinol, Sodium lauryl sulfate, Sodium Sulfate, Tocopherol, 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 DailyMedingredient 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
Anti-Itch Medicated Maximum Strength 200 mg/g; 30 mg/g 00363-2311-28 Walgreens 1 tube FDA listed
VAGISIL Anti-Itch Medicated Creme Maximum Strength 200 mg/g; 30 mg/g 11509-4402-01 Combe 1 tube FDA listed
Family Wellness 20 g/100g; 3 g/100gthis 55621-0016-01 Zhejiang 1 tube FDA listed
Feminine Anti-Itch Creme 5.67 g/28g; .85 g/28g 63868-0949-01 Quality 28 g FDA listed
Feminine Anti Itch Cream 20 g/100g; 3 g/100g 69396-0183-01 TRIFECTA 1 tube FDA listed
HealthWise Feminine Anti-itch Cream 5.67 g/28g; .85 g/28g 71101-0035-01 Veridian 28 g FDA listed
Caring Mills Vaginal Anti-Itch Cream 5.6 g/28g; .84 g/28g 71101-0039-01 Veridian 28.3 g FDA listed
HealthWise Feminine Anti-Itch Cream 5.67 g/28g; .85 g/28g 71101-0049-01 Veridian 28 g FDA listed
Caring Mills Vaginal Anti-Itch Cream 20 g/100g; 3 g/100g 71101-0065-01 Veridian 28.3 g FDA listed
HealthWise Feminine Anti-itch Cream 20 g/100g; 3 g/100g 71101-0066-01 Veridian 28.3 g FDA listed
Meijer Vagicaine 200 mg/g; 30 mg/g 79481-0130-01 Meijer, 1 tube FDA listed
Equate Vagicaine 200 mg/g; 30 mg/g 79903-0233-01 Walmart 1 tube FDA listed
Thera Plus Maximum Strength Feminine Anti-Itch 200 mg/g; 30 mg/g 80684-0142-00 FOURSTAR 28 g FDA listed
Maximum OTC Strength Feminine Anti-Itch Creme 5.67 g/28g; .85 g/28g 83324-0019-01 Quality 28.3 g 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

🏛️
2017
On the market since
Aug 2017
📍
2026
Currently FDA-listed
9 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.

🔬 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 DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE — the ingredient across all brands.

Top reported reactions

Fatigue72
Pain72
Nausea66
Diarrhoea61
Rash61
Headache58
Pruritus51

Reporter sex

799 reports
Male · 31%
Female · 69%

Serious outcomes

Death56
Life-threatening14
Disabling11
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 120 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
55621-0016-01 You're viewing this 1 TUBE in 1 CARTON (55621-016-01) / 28 g in 1 TUBE 2017-08-20 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 55621-016-01, 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: 55621-0016-01, written without dashes as 55621001601. 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 55621-0016-01, the first segment (55621) is the labeler code FDA assigned to Zhejiang Jingwei Pharmaceutic Al Co., Ltd.; the middle segment (0016) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 Zhejiang Jingwei Pharmaceutic Al Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zhejiang Jingwei Pharmaceutic Al Co., Ltd. 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 4 words

temporarily relieves itching Uses

⏱️ Dosage and Administration 37 words

Directions • Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to the affected area not more than 3 to 4 times daily. •: ask a doctor Children udner 12 years

⚠️ Warnings 52 words

. Warnings For external use only avoid contact When using this product with the eyes. if condition Stop use and ask a doctor worsens, or if symptoms persists for more than 7 days or clear up and occur again within a few days. over large areas of the body. Do not apply

📦 Storage and Handling 12 words

Other information Atore at 20° - 25° C (68° - 77° F).

🧪 Active Ingredient 6 words

Active ingredients Benzocaine 20% Resorcinol 3%

🧪 Inactive Ingredients 32 words

Inactive ingredients Aloe barbadensis leaf juice, Cetyl alcohol, Cholecalciferol, EDTA, Fragrance, Glyceryl stearate, Isopropyl myristate, Isopropyl palmitate, Lanolin, Methylparaben, Mineral Oil, Petrolatum, Propylene glycol, Retinol, Sodium lauryl sulfate, Sodium Sulfate, Tocopherol, Water

🎯 Purpose 5 words

Purpose External Analgesic External Analgesic

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