Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Sooth-a-Sting BENZOCAINE .12 g/.6mL; .006 g/.6mL Swab, 10 ampules — NDC 50332-0050-0 (Billing 50332-0050-00)
by HART Health · 10 AMPULE in 1 BOX / .6 mL in 1 AMPULE
This is a package of 10 ampules of Sooth-a-Sting BENZOCAINE .12 g/.6mL; .006 g/.6mL Swab from HART Health, marketed since Jan 2000 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.
NDC 50332-0050-00
🏷️ FDA NDC (as labeled)
50332-0050-0
billing pads the package segment with a zero
This package
Contains10 ampules
Pack sizes2 compare ↓
Main listing for product 50332-0050 · Also comes in:
100 ampules 50332-0050-4
🗂️ 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 →
⚠️
Other active recalls for Benzocaine (different manufacturers) — 6 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0602-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0605-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0601-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0603-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0604-2026
Class II · May 21, 2026 — Defective container:may contain bottles with incomplete seals (Keystone Industries) · FDA recall D-0606-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
50332-0050-0
Product NDC
50332-0050
11-digit billing NDC
50332005000
RxCUI
1037117
UNII
U3RSY48JW5, L7T10EIP3A
Application #
M
SPL Set ID
bd7229b6-813a-4149-bfe2-fe682f270ff4
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
2000-01-01
Route
TOPICAL
Dosage form
SWAB
Substance
BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Quick answers
- RxCUI (RxNorm): 1037117
Why two NDCs?
The FDA registers this code as 50332-0050-0 — a 5-4-1 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 package segment → 50332-0050-00. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
🧪 What is this product?
Sooth-a-Sting is a topical swab product containing benzocaine and menthol. Benzocaine is a local anesthetic typically used to numb minor pain and discomfort on the skin or mucous membranes on contact. Menthol is commonly included in topical products for its cooling sensation and mild analgesic properties. This is an over-the-counter monograph drug, meaning it is marketed under FDA's established rules for this drug category rather than through an individual application review.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Benzocaine — tap one for details:
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
💬 Questions about BENZOCAINE?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 each | 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:
100 ampules
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 50332-0050-00 You're viewing this Main listing | 10 AMPULE in 1 BOX / .6 mL in 1 AMPULE | 2000-01-01 | — | Active |
| 50332-0050-04 50332-0050-4 | 100 AMPULE in 1 BAG / .6 mL in 1 AMPULE | 2000-01-01 | — | Active |
Pack size FAQ
What quantity is in this package?
This package contains 10 ampules — 10 ampule in 1 box / .6 ml in 1 ampule.
How does this package differ from NDC 50332-0050-04?
Both are Sooth-a-Sting BENZOCAINE .12 g/.6mL; .006 g/.6mL Swab — the drug itself is identical. This page's package is the 10 ampules one, while NDC 50332-0050-04 is the 100 ampules package.
What NDC number is used to bill for this package of Sooth-a-Sting BENZOCAINE .12 g/.6mL; .006 g/.6mL Swab?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| First Aid Only Sting Relief .12 g/.6mL; .006 g/.6mL 00924-5250-01 | Acme | 10 ampules | — | — | FDA listed | — |
| Medicaine Sting and Bite .12 g/.6mL; .006 g/.6mL 46414-2040-03 | James | 6 ml | — | — | FDA listed | — |
| Sooth-a-Sting .12 g/.6mL; .006 g/.6mLthis 50332-0050-00 | HART | 10 ampules | — | — | FDA listed | — |
| Medicaine Sting and Bite .12 g/.6mL 67777-0405-02 | Dynarex | 10 ampules | — | — | FDA listed | — |
| Sting Relief Swab .006 g/.6mL; .12 g/.6mL 82749-0010-01 | Epic | 6 ml | — | — | FDA listed | — |
| Sting Relief Swab .006 g/.6mL; .12 g/.6mL 87251-0008-01 | 4 | 6 ml | — | — | FDA listed | — |
| Sting Relief Swab .006 g/.6mL; .12 g/.6mL 87251-0010-01 | 4 | 6 ml | — | — | 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2000
On the market since
Jan 2000
📍
2026
Currently FDA-listed
26 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.
- FDA Orange Book · refreshed Sep 3, 2026
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 8J6RDU8L9X
A synthetic green dye used to color medications. It helps make pills and capsules visually distinct so patients can easily identify their medicine.
-
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
-
UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
-
UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
-
UNII 5655G9Y8AQ
A synthetic liquid polymer used as a solvent and humectant in medications. It helps dissolve active ingredients, maintain moisture in the formulation, and improve how the medicine flows and is absorbed.
-
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.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesD&C green dye#5, D&C yellow dye #10, FD&C blue dye #1, PEG 300 NF, isopropyl alcohol, purified water USP
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.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerHART Health
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code50332
First marketedJan 2000
Product typeHuman Otc Drug
Portfolio36 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Stop Use and Ask a Doctor If
📄 Keep Out of Reach of Children
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses Temporarily relief of pain and itching associated with insect bites insect stings
⏱️ Dosage and Administration ▾
Directions remove stinger carefully reverse cardboard sleeve crush tube between thumb and forefinger to release fluid apply on and aroundpoint of insect puncture do not reuse swab dispose of swab properly
⚠️ Warnings ▾
Warnings For external use only do not get in eyes not for prolonged use Allergy alert: A severe allertig reaction to insect bites and stings may require life support measures. In such cases, immediately call 911 or your local emergency provider.
🧪 Active Ingredient ▾
Active Ingredients Benzocaine 20% L-Menthol 1%
🧪 Inactive Ingredients ▾
Inactive Ingredient D&C green dye#5, D&C yellow dye #10, FD&C blue dye #1, PEG 300 NF, isopropyl alcohol, purified water USP
🎯 Purpose ▾
Purpose Topical Anesthetic Topical Anesthetic
📄 Do Not Use ▾
Do not use in or near the eyes or over large portions of the body more than 3-4 times daily
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if condition persists unusual redness, swelling, rash, or irritation occurs
📄 Keep Out of Reach of Children ▾
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away 1-800-222-1222
📄 Package Label / Principal Display Panel ▾
0440StingSwab23f.jpg
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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 Sooth-a-Sting (this brand).
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 HART Health. 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 100 ampules (50332-0050-04). 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?
HART Health 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.
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.