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Allergy Relief Childrens Diphenhydramine HCl 12.5 mg Tablet, Chewable — NDC 68016-051-18 (Billing 68016-0051-18)

by Chain Drug Consortium · 3 BLISTER PACK in 1 CARTON / 6 TABLET, CHEWABLE in 1 BLISTER PACK

This is a package of Allergy Relief Childrens Diphenhydramine HCl 12.5 mg Tablet, Chewable from Chain Drug Consortium, no longer marketed (first marketed Apr 2011), no longer in the FDA NDC Directory, this package's marketing ended Jun 2026. It is this product's only package size.

NDC 68016-0051-18
🏷️ FDA NDC (as labeled) 68016-051-18 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 2, 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 68016-051-18 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68016 labeler · 051 product · 18 package
Package marketed since
Apr 25, 2011
Package marketing ended
Jun 30, 2026
Sample package
No — commercial package
Barcode (UPC)
0840986035227
FDA record last changed
Jul 2, 2026
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jun 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-051-18
Product NDC 68016-051
11-digit billing NDC 68016005118
RxCUI 1049900
UNII TC2D6JAD40
UPC 0840986035227
Application # M012
SPL Set ID 2df381f1-bace-46c6-831d-7f31c13f0fff
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 Discontinued
FDA listing status Discontinued by firm (certified through Jun 2026)
Marketing start 2011-04-25
Marketing end 2026-06-30
Route ORAL
Dosage form TABLET, CHEWABLE
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1049900
Why two NDCs? The FDA registers this code as 68016-051-18 — 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 → 68016-0051-18. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Oral products temporarily relieve hay fever and other upper respiratory allergy symptoms like runny nose, sneezing and itchy, watery eyes. They also ease runny nose and sneezing fr...
  • Oral forms are generally taken every 4 to 6 hours, with no more than 6 doses in 24 hours. The amount depends on age and the product, so check the package chart or ask me or your do...
  • It can. Drowsiness is common, so be careful driving or using machinery. Alcohol, sedatives and tranquilizers make it worse, so avoid them.
  • Oral products are not for children under 2 years, and some are not for children under 6. Children can become excitable, and overdose can be very dangerous. Always follow the age di...
📖 Read our full Diphenhydramine guide →

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 eachPer 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
68016-0051-18 You're viewing this Main listing 3 BLISTER PACK in 1 CARTON / 6 TABLET, CHEWABLE in 1 BLISTER PACK 2011-04-25 Jun 30, 2026 Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice 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 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 mgthis 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

🏛️
2011
On the market since
Apr 2011
📍
2026
Currently FDA-listed
15 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.

🧪 Avoiding an ingredient? See Diphenhydramine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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.

Manufacturer & labeler

LabelerChain Drug Consortium
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedApr 2011
Product typeHuman Otc Drug
Portfolio33 products on file

More NDCs from Chain Drug Consortium labeler code 68016

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 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 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 128 words ▾

Warnings Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis 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 alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages 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 (1-800-222-1222) 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 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) 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 25 words ▾

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

🎯 Purpose 2 words ▾

Purpose Antihistamine

📄 Do Not Use 19 words ▾

Do not use with any other product containing diphenhydramine, even one used on skin to make a child sleepy

📄 Ask a Doctor Before Use If 28 words ▾

Ask a doctor before use if you have glaucoma a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

📄 When Using This Product 34 words ▾

When using this product marked drowsiness may occur alcohol, sedatives, and tranquilizers may increase drowsiness use caution when driving a motor vehicle or operating machinery avoid alcoholic beverages excitability may occur, especially in children

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 22 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 138 words ▾

Principal display panel Premier Value ® *COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN’S BENADRYL ® CHEWABLES Children's Allergy Relief Diphenhydramine HCl 12.5 mg Chewable Tablets ANTIHISTAMINE Relief for: • Sneezing • Itchy throat • Runny nose • Itchy, watery eyes Chew or crush tablets completely before swallowing. 18 Chewable Tablets Cherry flavored TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Children’s Benadryl® Chewables.

50844 REV1218A59944 Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. Premier Value 44-599 Premier Value 44-599

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

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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Chain Drug Consortium 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.
← 68016-0023-43 · Chain 68016-0053-10 · Premier →
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.