Childrens Chewable Allergy Relief Diphenhydramine Hydrochloride 12.5 mg Tablet, Chewable
by KROGER COMPANY · 2 BLISTER PACK in 1 CARTON (41226-669-02) / 10 TABLET, CHEWABLE in 1 BLISTER PACK
NDC 41226-0669-02
🏷️ FDA NDC (as labeled)
41226-669-02
billing pads the product segment with a zero
OTC
On market
Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
🆔 Identity & classification
FDA NDC (as labeled)
41226-669-02
Product NDC
41226-669
11-digit billing NDC
41226066902
RxCUI
1049900
UNII
TC2D6JAD40
Application #
M012
SPL Set ID
2cac72be-4830-ad49-e063-6394a90a7832
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
2025-04-30
Route
ORAL
Dosage form
TABLET, CHEWABLE
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 41226-669-02 — 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 → 41226-0669-02. 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.
🏭 Manufacturer & labeler
LabelerKROGER COMPANY
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code41226
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio261 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📖 What it is MedlinePlus · NLM
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 ↗📗 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...
Patient education
Supplement & herbal interactions
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.
💬 Questions about Diphenhydramine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
purple
ShapeRound
Imprint122
Size13 mm
ScoringNot scored
FlavorGrape
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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII 5C5403N26O
Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
-
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
-
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 ECW0LZ41X8
A synthetic red dye used to color tablets and capsules. It helps make medicines visually distinctive so patients can easily identify their medication.
-
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 OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
-
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.
-
UNII W4888I119H
Tartaric acid is a natural organic acid found in grapes and tamarinds. In medicines, it works as a buffer to control acidity, an antioxidant to prevent spoilage, and sometimes a flavoring or binding agent.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesacacia, crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7, dextrose monohydrate, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sucralose, sucrose, tartaric acid
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed —
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price 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 mgthis 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 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
Apr 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.
🔬 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 Chewable Allergy Relief (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 29%
Female · 71%
Unknown · 0%
Serious outcomes
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 |
|---|---|---|---|
| 41226-0669-02 You're viewing this | 2 BLISTER PACK in 1 CARTON (41226-669-02) / 10 TABLET, CHEWABLE in 1 BLISTER PACK | 2025-04-30 | Active |
🧭 About this NDC listing & data coverage
Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.
Questions about this listing
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 41226-669-02, 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: 41226-0669-02, written without dashes as 41226066902. 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 41226-0669-02, the first segment (41226) is the labeler code FDA assigned to KROGER COMPANY; the middle segment (0669) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 KROGER COMPANY. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
KROGER COMPANY 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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: -runny nose -sneezing -itchy, watery eyes -itching of the nose or throat
⏱️ Dosage and Administration ▾
Directions find right dose on chart below take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours Age (years) 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 ▾
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 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 alcohol 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 (1-800-222-1222).
🧪 Active Ingredient ▾
Active ingredient (in each chewable tablet) Diphenhydramine HCl 12.5 mg
🧪 Inactive Ingredients ▾
Inactive ingredients acacia, crospovidone, D&C red no. 30 aluminum lake, D&C red no. 7, dextrose monohydrate, ethylcellulose, FD&C blue no. 1 aluminum lake, flavors, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, sucralose, sucrose, tartaric acid
🎯 Purpose ▾
Purpose Antihistamine
No label section mentions that — try another word, or open the full label on DailyMed below.
Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
Prefer the government’s original formatting? View this label on DailyMed ↗
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.