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Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride 1 g/100mL; 2 g/100mL Lotion, 118 mL — NDC 11383-0192-04 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride 1 g/100mL; 2 g/100mL Lotion, 118 mL — NDC 11383-192-04 (Billing 11383-0192-04)

by Weeks & Leo Co., Inc. · 118 mL in 1 BOTTLE

This is a package of 118 mL of Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride 1 g/100mL; 2 g/100mL Lotion from Weeks & Leo Co., Inc., marketed since Jun 2015 and currently FDA-listed.

NDC 11383-0192-04
🏷️ FDA NDC (as labeled) 11383-192-04 billing pads the product segment with a zero
This package
Contains118 mL Pack sizes2 compare ↓
Product page 11383-0192-01 Also comes in: 118 mL 11383-192-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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

NDC database record

One package, one record: these facts belong to NDC 11383-192-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
11383 labeler · 192 product · 04 package
Package marketed since
Jun 15, 2015
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 1138319204 7
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11383-192-04
Product NDC 11383-192
11-digit billing NDC 11383019204
RxCUI 1292321
UNII 88AYB867L5, TC2D6JAD40
Application # M017
SPL Set ID 0a4d471b-c3f3-0a6a-e063-6394a90ad57b
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2015-06-15
Route CUTANEOUS
Dosage form LOTION
Substance PRAMOXINE HYDROCHLORIDE; DIPHENHYDRAMINE HYDROCHLORIDE

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

GCN Seq No 065639
GCN 27656
HICL code 036634
Ingredient (HICL) Pramoxine Hcl/Diphenhydramine
HIC1 code L
Therapeutic class — broad (HIC1) Skin/Subcutaneous Tissue
HIC2 code L3
Therapeutic class — intermediate (HIC2) Protectives
HIC3 code L3P
Therapeutic class — specific (HIC3) Antipruritics,Topical
AHFS code 84:08.00.00
AHFS class Antipruritics And Local Anesthetics
FDB label name SOLARHIST 1%-2% LOTION
FDB brand name Solarhist
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 065639
  • GCN: 27656
  • HICL (First Databank): 036634
  • AHFS class code: 84:08.00.00
  • RxCUI (RxNorm): 1292321
Why two NDCs? The FDA registers this code as 11383-192-04 — 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 → 11383-0192-04. 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 Local anesthetics class.

Drug family (ATC) Local anesthetics, Anesthetics for topical use
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 SOLARHIST 1%-2% LOTION Ingredient Pramoxine Hcl/Diphenhydramine
📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Diphenhydramine is used to treat allergy and cold symptoms: sneezing runny nose red, itchy, watery eyes itching of the nose or throat Diphenhydramine is also used to treat insomnia (difficulty falling asleep or staying asleep) in adults, but should not be used to make a child sleepy. Diphenhydramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms. Diphenhydramine is also available in combination with other medications. This monograph only includes information about the use of diphenh...

Read the full MedlinePlus article ↗
🧪 What is this product?

Bite and Itch is an over-the-counter lotion applied to the skin to help relieve itching and discomfort from insect bites and minor skin irritation. It contains diphenhydramine hydrochloride, an antihistamine that is commonly used to reduce itching sensations, and pramoxine hydrochloride, a local anesthetic that functions to numb the affected area. This product is marketed as an OTC monograph drug, meaning it follows FDA's established rules for this category of skin-relief products rather than being individually reviewed.

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 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: 118 mL
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
11383-0192-01 11383-192-01 Main listing 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE 2015-06-15 — Active
11383-0192-04 You're viewing this 118 mL in 1 BOTTLE 2015-06-15 — Active

Pack size FAQ

What quantity is in this package?
This package contains 118 mL — 118 ml in 1 bottle.
What NDC number is used to bill for this package of Bite and Itch Diphenhydramine Hydrochloride, Pramoxine Hydrochloride 1 g/100mL; 2 g/100mL Lotion?
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Bite and Itch 1 g/100mL; 2 g/100mLthis 11383-0192-04 Weeks 118 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.

Availability & generic status

🏛️
2015
On the market since
Jun 2015
📍
2026
Currently FDA-listed
11 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.

What it looks like

Color white
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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 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 H5RIZ3MPW4
    A chemical preservative used to prevent bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII RD25J5V947
    A waxy mixture derived from vegetable oils and polyethylene glycol that helps emulsify and blend oil-based and water-based ingredients. It's used in creams and lotions to create a smooth, uniform texture and improve product stability.
  • 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 L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • 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 0A0VSM3HAD
    A synthetic emulsifier made from polyethylene glycol and stearic acid. It helps blend oil and water-based ingredients together and improves the texture and consistency of the medicine.
  • 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 Z8IX2SC1OH
    Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
  • 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 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.

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

The official label also statesInactive ingredients cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

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

LabelerWeeks & Leo Co., Inc.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code11383
First marketedJun 2015
Product typeHuman Otc Drug
Portfolio10 products on file

More NDCs from Weeks & Leo Co., Inc. labeler code 11383

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 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Other Information 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 26 words ▾

Uses Temporarily relieves pain and itching due to: scrapes sunburn minor cuts minor burns insect bites minor skin irritations poison ivy, poison oak, or poison sumac

⏱️ Dosage and Administration 34 words ▾

Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor

⚠️ Warnings 177 words ▾

Warnings For external use only Do not use on large areas of the body with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if condition gets worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on large areas of the body with any other product containing diphynhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox measles When using this product do not get into eyes Stop use and ask a doctor if conditions get worse symptoms last for more than 7 days or clear up and occur again within a few days Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

🧪 Active Ingredient 13 words ▾

Active ingredients Diphenhydramine HCl 2% Pramoxine HCl 1% Purposes Topical analgesic Topical analgesic

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients cetyl alcohol, diazolidinyl urea, glyceryl stearate, isopropyl myristate, menthol, methylparaben, PEG-100 stearate, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, stearyl alcohol

🎯 Purpose 5 words ▾

Purposes Topical analgesic Topical analgesic

📄 Do Not Use 20 words ▾

Do not use on large areas of the body with any other product containing diphynhydramine, even one taken by mouth

📄 Ask a Doctor Before Use If 11 words ▾

Ask a doctor before use if you have chicken pox measles

📄 When Using This Product 9 words ▾

When using this product do not get into eyes

📄 Stop Use and Ask a Doctor If 27 words ▾

Stop use and ask a doctor if conditions get worse symptoms last for more than 7 days or clear up and occur again within a few days

📄 Keep Out of Reach of Children 19 words ▾

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

📄 Other Information 18 words ▾

Other information store at controlled room temperature call (515) 276-1586 to report any side effects that may occur

📖 Instructions for Use 34 words ▾

Directions do not use more often than directed adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 years: ask a doctor

📄 Recent Major Changes 8 words ▾

Added Dosage and Administration section Updated Warnings section

📄 Package Label / Principal Display Panel 24 words ▾

Bite and Itch Lotion Pramoxine HCl 1% Topical Anesthetic Diphenhydramine HCl 2% Antihistamine Pain Relieving Lotion 4 Fl Oz (118 mL) Principal Display Panel

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

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 Weeks & Leo Co., Inc.. 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 1 bottle (11383-0192-01). 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?
Weeks & Leo Co., Inc. 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.
← 11383-0003-06 · Weeks 11383-0253-02 · Weeks →
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.