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Itch Relief Cream Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2% 2 g/100g; .1 g/100g Cream — NDC 68016-0163-01 package photo

Itch Relief Cream Zinc Acetate 0.1%, Diphenhydramine hydrochloride 2% 2 g/100g; .1 g/100g Cream

by Pharmacy Value Alliance LLC · 1 TUBE in 1 BOX (68016-163-01) / 28 g in 1 TUBE
NDC 68016-0163-01
🏷️ FDA NDC (as labeled) 68016-163-01 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 →

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) 68016-163-01
Product NDC 68016-163
11-digit billing NDC 68016016301
RxCUI 1087026
UNII TC2D6JAD40, FM5526K07A
UPC 0840986012761
Application # M017
SPL Set ID 37fe6d82-adee-4f58-e054-00144ff88e88
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 2016-07-19
Route TOPICAL
Dosage form CREAM
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Why two NDCs? The FDA registers this code as 68016-163-01 — 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 → 68016-0163-01. 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.

🏭 Manufacturer & labeler

LabelerPharmacy Value Alliance LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedJul 2016
Product typeHuman Otc Drug
Portfolio19 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

📖 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?

This is an over-the-counter topical cream marketed under FDA's monograph rules for itch relief. It contains diphenhydramine hydrochloride, an antihistamine typically used to reduce itching and irritation, and zinc acetate, a mineral salt commonly used in skin-care products for its astringent and soothing properties. The cream is applied directly to affected skin areas.

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 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 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 N72LMW566G
    A synthetic cleansing agent derived from lauryl alcohol and ethylene oxide. It helps dissolve and mix oil and water-based ingredients in liquid medicines, acting as an emulsifier and solubilizer.
  • 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 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 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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 statesAloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

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
good sense itch relief 2 g/100g; .1 g/100g 00113-0622-64 L. 1 tube $0.057 — Availability likely —
Banophen 2 g/100g; .1 g/100g 00904-5354-31 Major 1 tube $0.057 — Availability likely —
diphenhydramine hcl and zinc acetate 2 g/100g; .1 g/100g 45802-0358-03 Padagis 1 tube $0.057 — Availability likely —
GNP Extra Strength Anti-Itch Cream .1 g/100g; 2 g/100g 46122-0804-36 Amerisource 1 tube $0.057 — Availability likely —
leader anti itch 2 g/100g; .1 g/100g 70000-0388-01 Cardinal 1 tube $0.057 — Availability likely —
foster and thrive anti itch cream 2 g/100g; .1 g/100g 70677-1289-01 Strategic 1 tube $0.057 — 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/100gthis 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/g 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

🏛️
2016
On the market since
Jul 2016
📍
2026
Currently FDA-listed
10 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
68016-0163-01 You're viewing this 1 TUBE in 1 BOX (68016-163-01) / 28 g in 1 TUBE 2016-09-01 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 68016-163-01, 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: 68016-0163-01, written without dashes as 68016016301. 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 68016-0163-01, the first segment (68016) is the labeler code FDA assigned to Pharmacy Value Alliance LLC; the middle segment (0163) 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 Pharmacy Value Alliance LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Pharmacy Value Alliance 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 41 words ▾

Uses For the temporary relief from pain and itcing assciated with: insect bites minor burns sunburn minor skin irritation minor cuts rashes due to poison ivy, poison oak, and poison sumac dries weeping and oozing of poison ivy, oak, and sumac

⏱️ Dosage and Administration 37 words ▾

Directions Do not use more than directed Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor

⚠️ Warnings 46 words ▾

Warnings For External Use only Do not use on large areas of the body or with any other product containing diphenhydramine, even one taken by mouth Ask a doctor before use if you have chicken pox or measles When using this product avoid contact with eyes.

📦 Storage and Handling 14 words ▾

Other Information Store at controlled room temperature 20°-25°C (68°-77°F) Close cap tightly after use

🧪 Active Ingredient 10 words ▾

Active Ingredient Diphenhydramine Hydrochloride 2%

Active Ingredient Zinc Acetate 0.1%

🧪 Inactive Ingredients 26 words ▾

Inactive Ingredients Aloe Vera (Aloe Barbadensis), leaf juice, Cetyl alcohol, Glyceryl monostearate, Methylparaben, Mineral Pil, Petrolatum, Polyoxyethylene, lauryl ether, Propylene glycol, Propylparaben, Purified Water, Stearic acid

🎯 Purpose 6 words ▾

Purpose Topical Analgesic

Purpose Skin Protectant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 68016-0161-00 · Chain 68016-0165-00 · Pharmacy →
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.