NDC 51316-0153-18 — CVS PHARMACY DYE FREE Childrens Allergy Chews

🆔 Identity & classification

FDA NDC (as labeled) 51316-153-18

Product NDC 51316-153

11-digit billing NDC 51316015318

RxCUI 1049900

UNII TC2D6JAD40

Application # M012

SPL Set ID e6671e8b-653a-4f4e-b6f3-e31fcd14fbd7

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 2025-03-03

Route ORAL

Dosage form TABLET, CHEWABLE

Substance DIPHENHYDRAMINE HYDROCHLORIDE

Why two NDCs? The FDA registers this code as 51316-153-18 — 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 → 51316-0153-18. 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, INC.

FDA applicationM012 (OTC MONOGRAPH DRUG)

Labeler code51316

First marketedMar 2025

Product typeHuman Otc Drug

Portfolio128 products on file

🔎 All NDCs from CVS PHARMACY, INC.

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

📗 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.

💊 What it looks like

Color White

ShapeRound

ImprintRP012

Size16 mm

ScoringScored — splits in 2

FlavorBubble Gum

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.

Where does this data come from?

Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

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 mgthis 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 mg 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

🏛️

2025

On the market since

Mar 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.

📊 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 CVS PHARMACY DYE FREE Childrens Allergy Chews (this brand).

Top reported reactions

Completed Suicide760

Death530

Nausea456

Infusion Related Reaction450

Fatigue443

Dyspnoea408

Pain404

Age at onset

Neonate1

Infant1

Child9

Adolescent8

Adult130

Elderly43

Reporter sex

Male · 41%

Female · 57%

Unknown · 1%

Serious outcomes

Hospitalization2,703

Life-threatening452

Disabling161

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
51316-0153-18 You're viewing this	3 BLISTER PACK in 1 CARTON (51316-153-18) / 6 TABLET, CHEWABLE in 1 BLISTER PACK	2025-03-03	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	— Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured)	— Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 51316-153-18, 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: 51316-0153-18, written without dashes as 51316015318. 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 51316-0153-18, the first segment (51316) is the labeler code FDA assigned to CVS PHARMACY, INC.; the middle segment (0153) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) 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 CVS PHARMACY, INC.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

CVS PHARMACY, INC. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 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 31 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 107 words ▾

Directions ▪ find the right dose on chart below ▪ chew one tablet completely at the onset of symptoms. 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 (Year) Dose (chewable tablets) children under 2 years do not use children 2 to under 5 years do not use unless directed by a doctor children 6 to under 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 137 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 ▪ glaucoma ▪ a breathing problem such as emphysema or chronic bronchitis ▪ trouble urinating due to an enlarged 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 drinks ▪ alcohol, sedatives, and tranquilizers may increase drowsiness ▪ be careful 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 at 1-800-222-1222

📦 Storage and Handling 14 words ▾

Other information ▪ store at room temperature. ▪ Avoid high humidity. Protect from light.

🧪 Active Ingredient 10 words ▾

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

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients Crospovidone, dextrose, flavors, magnesium stearate, maltodextrin, potassium citrate, silica, sodium polystyrene sulfonate, starch, sucralose

🎯 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 51316 📚 All Histamine-1 Receptor Antagonist NDCsDrug class

CVS PHARMACY DYE FREE Childrens Allergy Chews Diphenhydramine HCl 12.5 mg Tablet, Chewable

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

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

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

Serious outcomes

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 FDA label — Drug Facts FDA SPL

🔗 Related NDC lookups