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TheraCare 2% Diphenhydramine Anti-Itch Cream Diphenhydramine Hydrochloride and Zinc Acetate 20 mg/g; 1 mg/g Cream, 1 tube — NDC 71101-0014-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

TheraCare 2% Diphenhydramine Anti-Itch Cream Diphenhydramine Hydrochloride and Zinc Acetate 20 mg/g; 1 mg/g Cream, 1 tube — NDC 71101-014-01 (Billing 71101-0014-01)

by Veridian Healthcare · 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE

This is a package of 1 tube of TheraCare 2% Diphenhydramine Anti-Itch Cream Diphenhydramine Hydrochloride and Zinc Acetate 20 mg/g; 1 mg/g Cream from Veridian Healthcare, marketed since Oct 2025 and currently FDA-listed. It is this product's only package size.

NDC 71101-0014-01
🏷️ FDA NDC (as labeled) 71101-014-01 billing pads the product 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

NDC database record

One package, one record: these facts belong to NDC 71101-014-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
71101 labeler · 014 product · 01 package
Package marketed since
Oct 1, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 7110101401 3
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 71101-014-01
Product NDC 71101-014
11-digit billing NDC 71101001401
RxCUI 1087026
UNII TC2D6JAD40, FM5526K07A
Application # M017
SPL Set ID 5999b677-63dd-49c6-b5b8-7b3c117ecc5c
Established class (EPC) Copper Absorption Inhibitor; Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
Physiologic effect Decreased Copper Ion Absorption
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-10-01
Route TOPICAL
Dosage form CREAM
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Quick answers
  • RxCUI (RxNorm): 1087026
Why two NDCs? The FDA registers this code as 71101-014-01 — 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 → 71101-0014-01. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Propionic acid derivatives, Antihistamines for topical use, Aminoalkyl ethers
How it works Histamine H1 Receptor Antagonists
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

📖 About the active ingredient: Diphenhydramine Hydrochloride; Zinc Acetate 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?

TheraCare 2% Diphenhydramine Anti-Itch Cream is a topical cream applied directly to skin. It contains diphenhydramine hydrochloride, an antihistamine commonly used to reduce itching and discomfort from minor skin irritation, and zinc acetate, a mineral salt often included in topical products for its soothing properties. This is an over-the-counter monograph product, meaning it is marketed under FDA's established rules for this category of anti-itch cream rather than as an individually reviewed drug application.

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.
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
71101-0014-01 You're viewing this Main listing 1 TUBE in 1 CARTON / 35.4 g in 1 TUBE 2025-10-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense itch relief 2 g/100g; .1 g/100g 00113-0622-64 L. 1 tube $0.058 — Availability likely —
Banophen 2 g/100g; .1 g/100g 00904-5354-31 Major 1 tube $0.058 — Availability likely —
diphenhydramine hcl and zinc acetate 2 g/100g; .1 g/100g 45802-0358-03 Padagis 1 tube $0.058 — Availability likely —
GNP Extra Strength Anti-Itch Cream .1 g/100g; 2 g/100g 46122-0804-36 Amerisource 1 tube $0.058 — Availability likely —
leader anti itch 2 g/100g; .1 g/100g 70000-0388-01 Cardinal 1 tube $0.058 — Availability likely —
foster and thrive anti itch cream 2 g/100g; .1 g/100g 70677-1289-01 Strategic 1 tube $0.058 — Availability likely —
Anti-Itch 20 mg/g; 1 mg/g 24385-0210-03 Amerisource 1 tube $0.130 — Discontinued —
Diphenhydramine Hydrochloride and Zinc Acetate 20 mg/g; 1 mg/g 70677-1213-01 STRATEGIC 1 tube $0.130 — FDA listed —
Walgreens Anti Itch Cream 20 mg/g; 1 mg/g 00363-2315-28 Walgreens 1 tube — — FDA listed —
Dr. Sheffield Anti Itch Cream 20 mg/g; 1 mg/g 11527-0069-04 Sheffield 1 tube — — FDA listed —
Anti-itch 20 mg/g; 1 mg/g 11673-0895-28 Target 1 tube — — FDA listed —
Rite Aid Extra Strength Itch Stopping 1 mg/g; 20 mg/g 11822-6614-01 Rite 1 tube — — FDA listed —
signature care itch relief 2 g/100g; .1 g/100g 21130-0154-64 Safeway 1 tube — — FDA listed —
anti itch 2 g/100g; .1 g/100g 30142-0582-64 Kroger 1 tube — — FDA listed —
Shopko Anti-Itch 20 mg/g; 1 mg/g 37012-0089-02 Shopko 1 tube — — FDA listed —
itch relief 2 g/100g; .1 g/100g 37808-0622-64 H 1 tube — — FDA listed —
Anti-Itch Cream 1 mg/g; 20 mg/g 41226-0888-02 Kroger 1 tube — — FDA listed —
Anti Itch 2 g/100g; .1 g/100g 41250-0622-64 Meijer 1 tube — — FDA listed —
Equate Anti Itch 2 g/100g; .1 g/100g 49035-0622-64 Wal-Mart 1 tube — — FDA listed —
Diphenhydramine Hydrochloride and Zinc Acetate 20 mg/g; 1 mg/g 51672-2089-02 Sun 1 tube — — FDA listed —
CAREALL Anti-Itch 20 mg/g; 1 mg/g 51824-0088-01 New 35 g — — FDA listed —
Extra Strength Itch Stopping 20 mg/g; 1 mg/g 52000-0071-02 Universal 1 tube — — FDA listed —
Discount Drug Mart Extra Strength Itch Stopping 20 mg/g; 1 mg/g 53943-0258-01 Discount 1 tube — — FDA listed —
Family Wellness 2 g/100g; .1 g/100g 55621-0007-01 Zhejiang 1 tube — — FDA listed —
ItchZap 20 mg/g; 1 mg/g 57237-0352-28 Rising 1 tube — — FDA listed —
Itch Relief 2 g/100g; .1 g/100g 59779-0708-64 CVS 1 tube — — FDA listed —
Itch Relief Cream 2 g/100g; .1 g/100g 68016-0163-01 Pharmacy 1 tube — — FDA listed —
Anti-Itch Cream 2 g/100g; .1 g/100g 69396-0025-05 Trifecta 1 tube — — FDA listed —
Itch stopping Cream 2 g/100g; .1 g/100g 69396-0150-01 Trifecta 1 tube — — FDA listed —
itch relief 1 mg/g; 20 mg/g 69452-0449-37 Bionpharma 1 tube — — FDA listed —
Family Wellness 2 g/100g; .1 g/100g 69571-0005-02 FRONT 1 tube — — FDA listed —
CVS Extra Strength Itch Stopping 20 mg/g; 1 mg/g 69842-0321-28 CVS 1 tube — — FDA listed —
Benadryl Extra Strength Itch Stopping 20 mg/g; 1 mg/g 69968-0223-01 Kenvue 1 tube — — FDA listed —
TheraCare 2% Diphenhydramine Anti-Itch Cream 20 mg/g; 1 mg/gthis 71101-0014-01 Veridian 1 tube — — FDA listed —
Caring Mill Anti-Itch Cream 20 mg/g; 1 mg/g 71101-0055-01 Veridian 1 tube — — FDA listed —
Anti-Itch Cream 2 g/100g; .1 g/100g 83324-0039-01 Chain 1 tube — — FDA listed —
Savvy Itch Stopping 2 g/100g; .1 g/100g 83650-0102-01 Savvy 35.4 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

🏛️
2025
On the market since
Oct 2025
📍
2026
Currently FDA-listed
1 year 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 I835H2IHHX
    A waxy substance derived from plant oils, used as an emulsifier and solubilizer to help mix oil and water ingredients together and keep them blended throughout the product's shelf life.
  • UNII 2DMT128M1S
    A waxy solid derived from plant or animal sources. It acts as an emulsifier to blend oil and water components, and also thickens the medicine to give it the right texture and consistency.
  • UNII 36W53O7109
    Chlorocresol is a phenolic antimicrobial chemical used as a preservative in liquid medicines and injectable solutions. It prevents bacterial and fungal growth to maintain product safety and shelf-life.
  • 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 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 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 4VON5FNS3C
    Sodium metabisulfite is a preservative derived from sulfur compounds. It prevents microbial growth and oxidation in medicines, helping extend shelf life and maintain product stability.
  • 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.

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

The official label also statesceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, polyethylene glycol, sodium metabisulfite, 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 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

LabelerVeridian Healthcare
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code71101
First marketedOct 2025
Product typeHuman Otc Drug
Portfolio130 products on file

More NDCs from Veridian Healthcare labeler code 71101

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 📦 Storage and Handling 🧪 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 42 words ▾

Uses temporarily relieves pain and itching associated with: insect bites minor burns sunburn minor skin irritations minor cuts scrapes rashes due to poison ivy, poison oak, and poison sumac dries the oozing and weeping of poison ivy, poison oak, and poison sumac

⏱️ Dosage and Administration 31 words ▾

Directions adults and children 2 years of age and overr: apply to affected area not more than 3 to 4 times daily children under 2 years of age: consult a physician

⚠️ Warnings 95 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 on chicken pox on measles When using this product avoid contact with eyes Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist 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.

📦 Storage and Handling 17 words ▾

Other information store at 20˚C-25 ˚C (68˚F-77˚F) do not use if tube seal under cap is broken

🧪 Active Ingredient 13 words ▾

Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, polyethylene glycol, sodium metabisulfite, water

🎯 Purpose 13 words ▾

Active ingredients Purpose Diphenhydramine hydrochloride 2% Topical analgesic Zinc acetate 0.1% Skin protectant

📄 Do Not Use 20 words ▾

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 10 words ▾

Ask a doctor before use on chicken pox on measles

📄 When Using This Product 8 words ▾

When using this product avoid contact with eyes

📄 Stop Use and Ask a Doctor If 33 words ▾

Stop use and ask a doctor if condition worsens or does not improve within 7 days symptoms persist 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.

📄 Questions or Comments 7 words ▾

Questions or comments? ca l l 1-866-326-1313

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL label

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 TheraCare 2% Diphenhydramine Anti-Itch Cream (this brand).

Top reported reactions

Genital Burning Sensation1

Reporter sex

1 reports
Male · 100%
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 1 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.

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 Veridian Healthcare. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Veridian Healthcare 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.
← 71101-0013-01 · Veridian 71101-0015-01 · Veridian →
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.