Home › NDC Lookup › Ingredients › Fexofenadine Hydrochloride › 61269-0527-94
Childrens Allergy fexofenadine hydrochloride 30 mg/5mL Suspension — NDC 61269-0527-94 package photo

Childrens Allergy fexofenadine hydrochloride 30 mg/5mL Suspension

by H2-Pharma, LLC · 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE
NDC 61269-0527-94
🏷️ FDA NDC (as labeled) 61269-527-94 billing pads the product segment with a zero
This package
Contains118 mL in 1 bottle Cost per mL$0.1174 NADAC Per package$13.85 / 118 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.0721/unit — full pricing hub ↓
Also comes in: 237 mL 61269-0527-98
OTC Generic 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 →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 61269-527-94
Product NDC 61269-527
11-digit billing NDC 61269052794
NCPDP billing unit ML — per mL (volume)
RxCUI 997491
UNII 2S068B75ZU
Application # ANDA203330
SPL Set ID 84988f6d-85b1-45dd-89be-0333acc6b180
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-07-18
Marketing end 2027-06-30
Route ORAL
Dosage form SUSPENSION
Substance FEXOFENADINE HYDROCHLORIDE
GCN Seq No 061995
GCN 97779
HICL code 011595
Ingredient (HICL) Fexofenadine Hcl
HIC1 code Z
Therapeutic class — broad (HIC1) Body As A Whole
HIC2 code Z2
Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code Z2Q
Therapeutic class — specific (HIC3) Antihistamines - 2Nd Generation
AHFS code 04:08.00.00
AHFS class Second Generation Antihistamines
FDB label name CHILD ALLERGY (FEXO) 30 MG/5ML
FDB brand name Children's Allergy
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 61269-527-94 — 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 → 61269-0527-94. 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) Other antihistamines for systemic use
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

LabelerH2-Pharma, LLC
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA203330 (ANDA)
Labeler code61269
First marketedJul 2022
Product typeHuman Otc Drug
Portfolio27 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

Label name CHILD ALLERGY (FEXO) 30 MG/5ML Ingredient Fexofenadine Hcl
📖 What it is MedlinePlus · NLM

Fexofenadine is used to treat allergy symptoms: runny nose sneezing red, itchy, or watering eyes itching of the nose or throat It is also used to treat itching and redness caused by hives. Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Fexofenadine is an antihistamine that relieves common allergy symptoms — things like a runny nose, sneezing, itchy or watery eyes, and an itchy nose or throat caused by hay fever o...
  • The FDA labels for fexofenadine do not list drowsiness as a side effect in the consumer sections provided. That said, everyone responds a little differently, so pay attention to ho...
  • You'll want to be careful here. The label says not to take fexofenadine at the same time as aluminum or magnesium antacids — the kind used for heartburn or upset stomach — and to a...
  • Can I take fexofenadine with my antacids or a glass of orange juice?
📖 Read our full Fexofenadine 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.

💊 What it looks like

FlavorBerry
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 3QPI1U3FV8
    A preservative derived from benzoic acid that prevents bacterial and fungal growth in medicines. It helps extend shelf life and maintain product safety during storage and use.
  • UNII 7FLD91C86K
    Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
  • UNII TUF2IVW3M2
    Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
  • 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 22ADO53M6F
    A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
  • UNII KH7I04HPUU
    A salt compound made from sodium and phosphoric acid, used as a buffer to help maintain a stable pH level in the medicine, and sometimes as a binder or filler in tablets and capsules.
  • 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 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesartificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.117 $13.85 / 118 ml
Medicaid paysCMS SDUD · 12 mo $0.0721 $8.51 / 118 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $0.117 $0.060
▲ Up 95% over the last 9 months.
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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 30 mg/5mLthis 61269-0527-94 H2-Pharma, 1 bottle $0.117 — Availability likely —
Childrens Fexofenadine Hydrochloride Allergy 30 mg/5mL 00363-2141-01 Walgreens 1 bottle — — FDA listed —
Children Allergy 30 mg/5mL 00363-2600-04 Walgreens 1 bottle — — FDA listed —
Dye Free Wal Fex childrens allergy 30 mg/5mL 00363-9230-04 Walgreens 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 37808-0623-04 H 1 bottle — — FDA listed —
Children Allergy 30 mg/5mL 37808-0654-04 H 1 bottle — — FDA listed —
Childrens Allegra Hives 30 mg/5mL 41167-4227-01 Chattem, 1 bottle — — FDA listed —
Childrens Allegra Allergy 30 mg/5mL 41167-4244-01 Chattem, 1 bottle — — FDA listed —
Childrens Allegra Allergy 30 mg/5mL 41167-4246-02 Chattem, 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 49035-0208-04 EQUATE 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 51316-0260-04 CVS 1 bottle — — FDA listed —
Childrens Fexofenadine Hydrochloride Allergy 30 mg/5mL 51672-2141-01 Sun 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 55319-0923-04 Family 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 55319-0957-04 Family 1 bottle — — FDA listed —
Fexofenadine Hydrochloride 30 mg/5mL 58602-0426-20 Aurohealth 1 bottle — — FDA listed —
Childrens Allergy 30 mg/5mL 79903-0249-04 WALMART 1 bottle — — FDA listed —
Childrens Fexofenadine Hydrochloride Allergy 30 mg/5mL 79903-0306-04 Wal-Mart 1 bottle — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2022
On the market since
Jul 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 61269-0527-94, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
7.5K
Units reimbursed last 4 qtrs
1.7M
Gross reimbursed last 4 qtrs
$125.2K
Avg / prescription
$16.58
Avg / unit
$0.0721
Latest quarter Q4 2025
2.3KRx
Medicaid pays / mL
$0.0721
gross reimbursed
vs
NADAC / mL
$0.1174
acquisition cost
=
Spread
−$0.0453
-39% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
22% FFS 78% MCO
Fee-for-service · 1,649 Rx Managed care · 5,900 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 17,433 units · 304 per 100k residents MN Wisconsin: 7,599 units · 129 per 100k residents WI Michigan: 130,785 units · 1,303 per 100k residents MI New York: no data reported NY Vermont: no data reported VT New Hampshire: 4,607 units · 329 per 100k residents NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: 85,387 units · 1,244 per 100k residents IN Ohio: 128,980 units · 1,094 per 100k residents OH Pennsylvania: 309,466 units · 2,388 per 100k residents PA New Jersey: 62,953 units · 678 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: 5,849 units · 99.5 per 100k residents CO Nebraska: no data reported NE Missouri: 70,464 units · 1,137 per 100k residents MO Kentucky: 171,830 units · 3,797 per 100k residents KY West Virginia: 46,056 units · 2,602 per 100k residents WV Virginia: 68,507 units · 786 per 100k residents VA Maryland: 151,469 units · 2,451 per 100k residents MD Connecticut: 94,913 units · 2,624 per 100k residents CT Rhode Island: 10,449 units · 954 per 100k residents RI Arizona: 36,216 units · 487 per 100k residents AZ New Mexico: 3,084 units · 146 per 100k residents NM Kansas: 23,490 units · 799 per 100k residents KS Arkansas: no data reported AR Tennessee: 4,110 units · 57.7 per 100k residents TN North Carolina: 11,472 units · 106 per 100k residents NC South Carolina: 64,493 units · 1,200 per 100k residents SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 7,459 units · 163 per 100k residents LA Mississippi: no data reported MS Alabama: 111,306 units · 2,179 per 100k residents AL Georgia: 92,676 units · 840 per 100k residents GA D.C.: 15,391 units · 2,267 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
57.73,797
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Kentucky 3,797 /100k
2 Connecticut 2,624 /100k
3 West Virginia 2,602 /100k
4 Maryland 2,451 /100k
5 Pennsylvania 2,388 /100k
6 D.C. 2,267 /100k
7 Alabama 2,179 /100k
8 Michigan 1,303 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page61269-0527-94 7,549 Rx · $125,198
1 bottle61269-0527-98 391 Rx · $7,571
Drug total (last 4 qtrs): 7,940 Rx · 1,833,933 units · $132,769 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

🔬 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 Diphenhydramine hydrochloride — the ingredient across all brands.

Top reported reactions

Fatigue16,399
Nausea14,606
Headache14,003
Pain11,969
Dyspnoea11,085
Pruritus10,525
Infusion Related Reaction9,947

Age at onset

Neonate106
Infant195
Child1,828
Adolescent1,476
Adult20,867
Elderly9,044

Reporter sex

171,992 reports
Male · 33%
Female · 66%
Unknown · 0%

Serious outcomes

Hospitalization49,087
Death23,392
Life-threatening7,190
Disabling3,673
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 18,193 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
61269-0527-94 You're viewing this 1 BOTTLE in 1 CARTON (61269-527-94) / 118 mL in 1 BOTTLE $0.1174 / mL $13.86 2022-07-18 Active
61269-0527-98 1 BOTTLE in 1 CARTON (61269-527-98) / 237 mL in 1 BOTTLE — — 2022-07-18 Discontinued by firm

In Medicaid, this is the most-dispensed pack of this product — about 95% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 61269-0527-94?
NDC 61269-0527-94 is listed by the FDA — 1 bottle in 1 carton / 118 ml in 1 bottle.
What NDC number is used to bill for this package of Childrens Allergy fexofenadine hydrochloride 30 mg/5mL Suspension?
Bill NDC 61269-0527-94 — the 11-digit billing format is 61269052794. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 90 words ▾

Directions shake well before using use only with enclosed dosing cup Note: mL = milliliters adults and children 12 years of age and over take 10 mL every 12 hours; do not take more than 20 mL in 24 hours children 2 to under 12 years of age take 5 mL every 12 hours; do not take more than 10 mL in 24 hours children under 2 years of age ask a doctor adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

⚠️ Warnings 122 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients. Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions ) Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. 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 31 words ▾

Other information each 5 mL contains: sodium 18 mg store between 20° to 25°C (68° to 77°F) before using any medication, read all label directions. Keep carton, it contains important information.

🧪 Active Ingredient 11 words ▾

Active ingredient (in each 5 mL) Fexofenadine HCl, USP 30 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients artificial raspberry flavor, butylparaben, edetate disodium, poloxamer 407, propylene glycol, propylparaben, purified water, sodium phosphate dibasic, sodium phosphate monobasic, sucrose, titanium dioxide, xanthan gum, xylitol

🎯 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 ↗
← 61269-0518-12 · H2-Pharma 61269-0565-90 · H2-Pharma →
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.