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Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE 2 g/100g; .1 g/100g Cream — NDC 69571-0005-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE 2 g/100g; .1 g/100g Cream — NDC 69571-005-02 (Billing 69571-0005-02)

by FRONT PHARMACEUTICAL PLC · 1 TUBE in 1 BOX / 28 g in 1 TUBE

This is a package of Family Wellness DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE 2 g/100g; .1 g/100g Cream from FRONT PHARMACEUTICAL PLC, marketed since Mar 2017 and currently FDA-listed. It is this product's only package size.

NDC 69571-0005-02
🏷️ FDA NDC (as labeled) 69571-005-02 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69571-005-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69571 labeler · 005 product · 02 package
Package marketed since
Mar 29, 2017
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0032251071829
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69571-005-02
Product NDC 69571-005
11-digit billing NDC 69571000502
RxCUI 1087026
UNII TC2D6JAD40, FM5526K07A
UPC 0032251071829
Application # M017
SPL Set ID fde2069b-344e-46da-bb95-c5113e0f35d6
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 2017-03-29
Route TOPICAL
Dosage form CREAM
Substance DIPHENHYDRAMINE HYDROCHLORIDE; ZINC ACETATE
Quick answers
  • RxCUI (RxNorm): 1087026
Why two NDCs? The FDA registers this code as 69571-005-02 — 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 → 69571-0005-02. 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?

This is an over-the-counter topical cream marketed under FDA's monograph rules for OTC drugs. It contains diphenhydramine hydrochloride, a first-generation antihistamine, and zinc acetate. Diphenhydramine is commonly used in creams to help reduce itching and skin irritation, while zinc acetate is typically included for its astringent and skin-soothing properties. The cream is applied directly to the skin.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Diphenhydramine Hydrochloride, Naproxen Sodium may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Diphenhydramine Hydrochloride, Naproxen Sodium nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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
69571-0005-02 You're viewing this Main listing 1 TUBE in 1 BOX / 28 g in 1 TUBE 2017-03-29 — 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/100gthis 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 —
topcare anti itch 2 g/100g; .1 g/100g 36800-0622-64 Topco 1 tube — — FDA listed —
Itch Stopping 2 g/100g; .1 g/100g 42507-0622-64 HyVee 1 tube — — 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
Mar 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.

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 FCZ5MH785I
    A waxy substance made from glycerin and stearic acid. It works as an emulsifier to help mix oil and water ingredients together, and as a thickener to give the medicine its proper texture and consistency.
  • 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 statescetyl alcohol, glyceryl stearate se, Inactive ingredients laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearic alcohol, 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

LabelerFRONT PHARMACEUTICAL PLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code69571
First marketedMar 2017
Product typeHuman Otc Drug
Portfolio17 products on file

More NDCs from FRONT PHARMACEUTICAL PLC labeler code 69571

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 📄 Keep Out of Reach of Children 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 28 words ▾

for temprary relief from pain and itching associated Uses with insect bites , sunburn and mior skin irritations. Dries the oozing and weeping of poison: •ivy •oak •sumac

⏱️ Dosage and Administration 33 words ▾

Directions •for adults and children over 2 years of age: apply to affected area not more than 3 to 4 times daily •children under 2 years of age: ask a doctor before use

⚠️ Warnings 72 words ▾

Warnings . For external use only Do not use •avoid contact with eyes When using this product Ask a doctor before use •on chicken pox •on measles Stop use and ask a doctor if over large areas of the body with any other product containing diphenhydramine including those taken orally symptoms last for more than 7 days the condition gets worse symptoms clear up and then occur again within a few days

🧪 Active Ingredient 8 words ▾

Active Ingredients Diphenhydramine hydrochloride 2% Zinc acetate 0.1%

🧪 Inactive Ingredients 20 words ▾

cetyl alcohol, glyceryl stearate se, Inactive ingredients laureth-23, methylparaben, mineral oil, petrolatum, propylene glycol, propylparaben, stearic acid, stearic alcohol, water

🎯 Purpose 5 words ▾

Purpose Topical analgesic Skin protectant

📄 Keep Out of Reach of Children 20 words ▾

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

📄 Other Information 14 words ▾

store at room temperature 59° - 86° F Other information (15° - 30° C).

📄 Questions or Comments 9 words ▾

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

📄 Package Label / Principal Display Panel 3 words ▾

label image description

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 Family Wellness (this brand).

Top reported reactions

Fatigue5,928
Condition Aggravated5,464
Nausea5,003
Rash4,919
Diarrhoea4,458
Pain4,430
Headache4,429

Age at onset

Neonate332
Infant314
Child1,043
Adolescent685
Adult7,958
Elderly3,430

Reporter sex

66,866 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization28,503
Death9,810
Life-threatening8,663
Disabling5,614
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 6,153 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 FRONT PHARMACEUTICAL PLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
FRONT PHARMACEUTICAL PLC 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.
← 69571-0004-02 · FRONT 69571-0006-02 · FRONT →
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.