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Childrens Allergy Fexofenadine HCL 30 mg/5mL Suspension — NDC 55319-957-04 (Billing 55319-0957-04)

by Family Dollar (FAMILY WELLNESS) · 1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC

This is a package of Childrens Allergy Fexofenadine HCL 30 mg/5mL Suspension from Family Dollar (FAMILY WELLNESS), no longer marketed (first marketed Oct 2023), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 55319-0957-04
🏷️ FDA NDC (as labeled) 55319-957-04 billing pads the product segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed 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

NDC database record

One package, one record: these facts belong to NDC 55319-957-04 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
55319 labeler · 957 product · 04 package
Package marketed since
Oct 31, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0032251914638
FDA record last changed
Jul 24, 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 Sep 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) 55319-957-04
Product NDC 55319-957
11-digit billing NDC 55319095704
RxCUI 997491
UNII 2S068B75ZU
UPC 0032251914638
Application # ANDA203330
SPL Set ID ba4df76e-cbed-4e19-afc6-c76000f0bf4f
Established class (EPC) Histamine-1 Receptor Antagonist
Mechanism of action Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Sep 2026)
Marketing start 2023-10-31
Route ORAL
Dosage form SUSPENSION
Substance FEXOFENADINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 997491
Why two NDCs? The FDA registers this code as 55319-957-04 — 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 → 55319-0957-04. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • It relieves hay fever and other upper respiratory allergy symptoms like runny nose, sneezing, and itchy, watery eyes. Some products, like Allegra Hives 24hr, are for hives and the...
  • No. The label says not to take it with fruit juices, so use water instead. Also avoid taking it at the same time as aluminum or magnesium antacids.
  • Can I take fexofenadine with fruit juice?
  • Yes, check with your doctor first. The label says your doctor should decide whether you need a different dose. The same goes for adults 65 and older.
📖 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.

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 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
55319-0957-04 You're viewing this Main listing 1 BOTTLE, PLASTIC in 1 BOX / 118 mL in 1 BOTTLE, PLASTIC 2023-10-31 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Allergy 30 mg/5mL 61269-0527-94 H2-Pharma, 1 bottle $0.119 — 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/5mLthis 55319-0957-04 Family 1 bottle — — Discontinued —
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

🏛️
2023
On the market since
Oct 2023
📍
2026
Currently FDA-listed
3 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.

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 Fexofenadine 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

LabelerFamily Dollar (FAMILY WELLNESS)
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA203330 (ANDA)
Labeler code55319
First marketedOct 2023
Product typeHuman Otc Drug
Portfolio63 products on file

More NDCs from Family Dollar (FAMILY WELLNESS) labeler code 55319

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 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 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 sneezing itchy, watery eyes itching of the nose or throat

⏱️ Dosage and Administration 90 words ▾

Direction shake well before using use only with enclosed dosing cup 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 Note: mL = milliliters

⚠️ Warnings 121 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 17 words ▾

Other information each 5 mL contains: sodium 17 mg store between 20º to 25ºC (68º and 77ºF)

🧪 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

📄 Do Not Use 19 words ▾

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 20 words ▾

Ask a doctor before use if you have kidney disease. Your doctor should determine if you need a different dose.

📄 When Using This Product 30 words ▾

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 19 words ▾

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.

🤰 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 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 128 words ▾

Principal Display Panel COMPARE TO ACTIVE INGREDIENT IN CHILDREN'S ALLEGRA® ALLERGY* Children's ALLERGY AGES 2 YEARS & UP FEXOFENADINE HCl ORAL SUSPENSION 30 mg/5mL Antihistamine Indoor/Outdoor allergy relief Sneezing Runny Nose Itchy, watery eyes Itchy nose or throat 12 Hour Relief Non-drowsy Alcohol-free DYE-FREE BERRY FLAVOR FL OZ (mL) Use only with enclosed dosing cup. Wash and let air dry after each use. *This product is not manufactured or distributed by Sanofi Consumer Healthcare NA, distributor of Children's Allegra® Allergy.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF SEAL ON BOTTLE PRINTED WITH "SEALED FOR SAFETY" IS TORN OR MISSING. DISTRIBUTED BY: MIDWOOD BRANDS, LLC, 500 VOLVO PKWY, CHESAPEAKE, VA 23320

Product Label FAMILY WELLNESS Children's Allergy Dye-Free Berry Flavor Fexofenadine HCl, USP 30 mg

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

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

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?
Family Dollar (FAMILY WELLNESS) 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.
← 55319-0954-12 · Family 55319-0960-08 · Family →
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.