NDC 59779-0585-07 — Childrens Allergy Relief Diphenhydramine HCl

🆔 Identity & classification

FDA NDC (as labeled) 59779-585-07

Product NDC 59779-585

11-digit billing NDC 59779058507

NCPDP billing unit EA — each (per item)

RxCUI 1049900

UNII TC2D6JAD40

UPC 0050428274262

Application # M012

SPL Set ID 8296049c-72fc-4200-9d45-c8e377314cf2

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 2009-03-20

Marketing end 2028-01-31

Route ORAL

Dosage form TABLET, CHEWABLE

Substance DIPHENHYDRAMINE HYDROCHLORIDE

GPI-14 41200030100510

GPI class CVS Allergy Relief Childrens

GCN Seq No 023635

GCN 46060

HICL code 004480

Ingredient (HICL) Diphenhydramine Hcl

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z2

Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants

HIC3 code Z2P

Therapeutic class — specific (HIC3) Antihistamines - 1St Generation

AHFS code 04:04.00.00

AHFS class First Generation Antihistamines

FDB label name CVS CHLD ALLRGY RLF 12.5MG CHW

FDB brand name Children's Allergy Relief

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 59779-585-07 — 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 → 59779-0585-07. 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

LabelerCVS Pharmacy

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code59779

First marketedMar 2009

Product typeHuman Otc Drug

Portfolio550 products on file

🔎 All NDCs from CVS Pharmacy

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

Label name CVS CHLD ALLRGY RLF 12.5MG CHW Ingredient Diphenhydramine Hcl

📗 Our plain-language guide HelloPharmacist

Diphenhydramine is mainly used to temporarily ease the stuffy, sneezy, itchy symptoms of allergies — like hay fever — and the common cold. Think runny nose, sneezing, watery or itc...
What exactly does diphenhydramine treat?
Yes, and that's one of the most important things to know about this medicine. Drowsiness is one of its most common effects — it crosses into the brain and that's what causes the se...
It depends on your child's age and the product. Most oral diphenhydramine products are not recommended for children under 6, and liquid products labeled for children are generally...

📖 Read our full Diphenhydramine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

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 ZK64F7XSTX
A red synthetic colorant made by combining D&C Red No. 27 dye with aluminum salts. It's used to give tablets, capsules, or other medicines their red or pink color.
UNII GE75M6YV5W
A synthetic red colorant made by combining D&C Red No. 30 dye with aluminum oxide. It's used to give tablets, capsules, or other medications their red color and appearance.
UNII LX22YL083G
A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
UNII 7Z8S9VYZ4B
Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
UNII J9EQA3S2JM
FD&C Blue No. 1 Aluminum Lake is a blue colorant made by combining FD&C Blue No. 1 dye with aluminum salts. It is used to color tablets, capsules, and other medicines for easy identification and appearance.
UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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 96K6UQ3ZD4
Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

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

The official label also statesD&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

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 system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Try another pack size: 6 tablets

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Allergy Relief Childrens 12.5 mg 46122-0425-89	Amerisource	5 tablets	$0.113	—	Availability likely	—
GOOD NEIGHBOR PHARMACY Childrens Allergy Relief 12.5 mg 46122-0798-51	AMERISOURCE	10 tablets	$0.113	—	Availability likely	—
WALGREENS Dye Free Chidrens Allergy Chews 12.5 mg 00363-1201-20	WALGREENS	10 tablets	—	—	FDA listed	—
WALGREENS Dye Free Chidrens Allergy Chews 12.5 mg 00363-2012-20	WALGREENS	10 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mg 00363-4808-09	Walgreen	5 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mg 00363-4810-09	Walgreen	5 tablets	—	—	FDA listed	—
up and up childrens allergy melts 12.5 mg 11673-0012-18	Target	6 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mg 11822-0599-04	Rite	6 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mg 36800-0585-44	Topco	6 tablets	—	—	FDA listed	—
allergy relief Childrens 12.5 mg 41163-0585-44	United	6 tablets	—	—	FDA listed	—
Childrens Chewable Allergy Relief 12.5 mg 41226-0669-02	KROGER	10 tablets	—	—	FDA listed	—
Allergy Relief Childrens 12.5 mg 41250-0599-44	Meijer	6 tablets	—	—	Discontinued	—
Childrens Allergy Relief 12.5 mg 49035-0599-09	Wal-Mart	5 tablets	—	—	FDA listed	—
Childrens Benadryl Chewables 12.5 mg 50580-0232-01	Kenvue	10 tablets	—	—	FDA listed	—
CVS PHARMACY DYE FREE Childrens Allergy Chews 12.5 mg 51316-0153-18	CVS	6 tablets	—	—	FDA listed	—
CVS PHARMACY Childrens Allergy Chews 12.5 mg 51316-0154-18	CVS	6 tablets	—	—	FDA listed	—
DISCOUNT DRUG MART Childrens Allergy Chewable 12.5 mg 53943-0033-20	DISCOUNT	10 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mgthis 59779-0585-07	CVS	6 tablets	—	—	FDA listed	—
Childrens Allergy Relief Dye Free 12.5 mg 59779-0869-44	CVS	6 tablets	—	—	FDA listed	—
Allergy Relief 12.5 mg 67091-0425-20	WinCo	5 tablets	—	—	FDA listed	—
Allergy Relief Childrens 12.5 mg 68016-0051-18	Chain	6 tablets	—	—	Discontinued	—
Drx Choice childrens allergy chews 12.5 mg 68163-0012-48	RARITAN	12 tablets	—	—	FDA listed	—
Dimetapp Cough and Allergy 12.5 mg 69536-0370-24	Foundation	6 tablets	—	—	FDA listed	—
Allergies MY CHILD NEEDS HELP WITH 12.5 mg 73418-0747-09	Unconditional	5 tablets	—	—	FDA listed	—
TOPCARE Childrens Allergy Chews 12.5 mg 76162-0201-20	Topco	10 tablets	—	—	FDA listed	—
MEIJER Childrens Allergy Relief Chews 12.5 mg 79481-0122-00	MEIJER	10 tablets	—	—	FDA listed	—
Childrens Allergy Relief 12.5 mg 79903-0189-20	WALMART	5 tablets	—	—	FDA listed	—
Walmart Dye Free Chidrens Allergy Chews 12.5 mg 79903-0967-20	WALMART	10 tablets	—	—	FDA listed	—
Walmart Dye Free Chidrens Allergy Chews Bubblegum 12.5 mg 79903-0968-20	WALMART	10 tablets	—	—	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

🏛️

2009

On the market since

Mar 2009

📍

2026

Currently FDA-listed

17 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.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Diphenhydramine HCl (matched by generic name) — the program that covers self-administered drugs. 8 manufacturers.

⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Diphenhydramine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.

Period

Total Part D spend

$374.3K

Claims incl. refills

20.3K

Beneficiaries

11.2K

Spend / beneficiary

$33.36

Spend / claim

$18.44

Trend by period

💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 childrens allergy relief (this brand).

Top reported reactions

Fatigue17,304

Pain15,124

Headache12,162

Nausea11,084

Rash10,729

Dyspnoea10,699

Arthralgia9,985

Age at onset

Neonate127

Infant97

Child1,130

Adolescent961

Adult17,557

Elderly8,425

Reporter sex

Male · 33%

Female · 67%

Unknown · 0%

Serious outcomes

Hospitalization41,358

Death15,209

Life-threatening9,040

Disabling8,742

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
59779-0585-07 You're viewing this	6 BLISTER PACK in 1 CARTON (59779-585-07) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	2009-03-20	Active
59779-0585-44	3 BLISTER PACK in 1 CARTON (59779-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	2009-03-20	Active

Pack size FAQ

What quantity is in NDC 59779-0585-07?

NDC 59779-0585-07 is listed by the FDA — 6 blister pack in 1 carton / 6 tablet, chewable in 1 blister pack.

What NDC number is used to bill for this package of Childrens Allergy Relief Diphenhydramine HCl 12.5 mg Tablet, Chewable?

Bill NDC 59779-0585-07 — the 11-digit billing format is 59779058507. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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	— Not published for this NDC No photo available yet for this listing.
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 59779-585-07, 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: 59779-0585-07, written without dashes as 59779058507. 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 59779-0585-07, the first segment (59779) is the labeler code FDA assigned to CVS Pharmacy; the middle segment (0585) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (07) 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 it is currently marketed — but CVS Pharmacy has reported a marketing end date of 2028-01-31, after which this package is expected to stop being marketed. 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 6 tablets (59779-0585-44). 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?

CVS Pharmacy 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 26 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose itchy, watery eyes sneezing itching of the nose or throat

⏱️ Dosage and Administration 98 words ▾

Directions find right dose on chart below chew or crush tablets completely before swallowing; do not swallow tablets whole take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (yr) Dose (chewable tablets) children under 2 years do not use children 2 to 5 years do not use unless directed by a doctor children 6 to 11 years 1 to 2 chewable tablets (12.5 mg to 25 mg) adults and children 12 years and over 2 to 4 chewable tablets (25 mg to 50 mg)

⚠️ Warnings 127 words ▾

Warnings Do not use to make a child sleepy with any other product containing diphenhydramine, even one used on skin Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product marked drowsiness may occur avoid alcoholic beverages alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery excitability may occur, especially in children If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 39 words ▾

Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) avoid high humidity see end flap for expiration date and lot number

🧪 Active Ingredient 10 words ▾

Active ingredient (in each chewable tablet) Diphenhydramine HCl 12.5 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredients D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, stearic acid, sucralose, sucrose

🎯 Purpose 2 words ▾

Purpose Antihistamine

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

🔗 Related NDC lookups

🧪 All Diphenhydramine Hcl NDCsSame ingredient 🏭 All CVS labeler NDCsLabeler code 59779 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — Antihistamines - 1St Generation.

Hydroxyzine Hcl 00093-5060-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.