NDC 80070-0100-12 — Alavert Allergy and Congestion D-12 hour

🆔 Identity & classification

FDA NDC (as labeled) 80070-100-12

Product NDC 80070-100

11-digit billing NDC 80070010012

RxCUI 1242399, 1242401

UNII 7AJO3BO7QN, Y9DL7QPE6B

Application # ANDA076050

SPL Set ID 1a669f3c-36a6-439e-843d-47638fa217e8

Established class (EPC) alpha-Adrenergic Agonist

Mechanism of action Adrenergic alpha-Agonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2021-12-15

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance LORATADINE; PSEUDOEPHEDRINE SULFATE

GPI-14 43993002597430

Why two NDCs? The FDA registers this code as 80070-100-12 — 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 → 80070-0100-12. 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 Other antihistamines for systemic use class.

Drug family (ATC) Other antihistamines for systemic use

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

LabelerFoundation Consumer Brands

Application holderPERRIGO PHARMA INTERNATIONAL DAC

FDA applicationANDA076050 (ANDA)

Labeler code80070

First marketedDec 2021

Product typeHuman Otc Drug

Portfolio13 products on file

🔎 All NDCs from Foundation Consumer Brands

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

Loratadine is used to treat allergy symptoms: sneezing runny nose itching of the nose or throat red, itchy, or watery eyes Loratadine 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.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

Great question. The two ingredients each do something different. Loratadine is an antihistamine — it targets the sneezing, runny nose, itchy eyes, and throat itching that come with...
What exactly does this medicine do, and why does it have two ingredients?
You take it by mouth with a full glass of water — but it's really important that you swallow it whole. Do not crush, split, chew, or dissolve it. These are extended-release tablets...
How do I take it, and does it matter if I crush or split the tablet?

📖 Read our full Loratadine / Pseudoephedrine 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

Imprint7U0

Size14 mm

ScoringNot scored

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 L11K75P92J
A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII 3NXW29V3WO
Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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 FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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.

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

The official label also statescroscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

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.

Try another pack size: 6 tablets

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
perrigo allergy d 5 mg/1; 120 mg 00113-7777-60	L.	1 tablet	$0.787	—	Availability likely	—
loratadine D 5 mg/1; 120 mg 45802-0122-46	Padagis	1 tablet	$0.787	—	Availability likely	—
Leader Allergy Relief D12 5 mg/1; 120 mg 70000-0504-01	Cardinal	1 tablet	$0.787	—	Availability likely	—
foster and thrive allergy D 12 hour 5 mg/1; 120 mg 70677-1024-01	Strategic	1 tablet	$0.787	—	Availability likely	—
Allergy and Congestion Relief 5 mg/1; 120 mg 00113-2007-46	L.	1 tablet	—	—	Discontinued	—
allergy relief d 12 5 mg/1; 120 mg 00363-7023-60	Walgreen	1 tablet	—	—	FDA listed	—
Claritin-D 12 Hour 5 mg/1; 120 mg 11523-7162-01	Bayer	10 tablets	—	—	FDA listed	—
Allergy Relief D 5 mg/1; 120 mg 11822-1055-00	Rite	1 tablet	—	—	FDA listed	—
signature care allergy and congestion relief 5 mg/1; 120 mg 21130-0482-60	Safeway	1 tablet	—	—	FDA listed	—
allergy and congestion relief 5 mg/1; 120 mg 30142-0786-65	Kroger	1 tablet	—	—	Discontinued	—
topcare allergy and congestion relief 5 mg/1; 120 mg 36800-0611-65	Topco	1 tablet	—	—	FDA listed	—
allergy relief d 5 mg/1; 120 mg 41250-0954-46	Meijer	1 tablet	—	—	Discontinued	—
good neighbor pharmacy loratadine d 5 mg/1; 120 mg 46122-0455-52	Amerisource	1 tablet	—	—	Discontinued	—
equate allergy and congestion relief 5 mg/1; 120 mg 49035-0643-46	Wal-Mart	1 tablet	—	—	FDA listed	—
allergy relief d 5 mg/1; 120 mg 56062-0555-46	Publix	1 tablet	—	—	FDA listed	—
kirkland signature allerclear d 12 hr 5 mg/1; 120 mg 63981-0723-65	Costco	1 tablet	—	—	FDA listed	—
allergy relief d 12 5 mg/1; 120 mg 69842-0641-46	CVS	1 tablet	—	—	FDA listed	—
Alavert Allergy and Congestion D-12 hour 5 mg/1; 120 mgthis 80070-0100-12	Foundation	6 tablets	—	—	FDA listed	—
loratadine D 5 mg/1; 120 mg 85766-0047-10	Sportpharm	1 tablet	—	—	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

🏛️

2021

On the market since

Dec 2021

📍

2026

Currently FDA-listed

5 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.

🔬 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 Alavert Allergy and Congestion D-12 hour (this brand).

Top reported reactions

Insomnia118

Dizziness85

Nausea67

Drug Effect Decreased60

Headache49

Fatigue45

Somnolence44

Age at onset

Child1

Adult24

Elderly12

Reporter sex

Male · 31%

Female · 69%

Unknown · 0%

Serious outcomes

Hospitalization118

Death27

Life-threatening16

Disabling12

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
80070-0100-12 You're viewing this	2 BLISTER PACK in 1 CARTON (80070-100-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2021-12-15	Active
80070-0100-24	4 BLISTER PACK in 1 CARTON (80070-100-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	2021-12-15	Active

Pack size FAQ

What quantity is in NDC 80070-0100-12?

NDC 80070-0100-12 is listed by the FDA — 2 blister pack in 1 carton / 6 tablet, film coated, extended release in 1 blister pack.

What NDC number is used to bill for this package of Alavert Allergy and Congestion D-12 hour LORATADINE and PSEUDOEPHEDRINE SULFATE 5 mg; 120 mg Tablet, Film Coated, Extended Release?

Bill NDC 80070-0100-12 — the 11-digit billing format is 80070010012. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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)	✓ 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.

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 80070-100-12, 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: 80070-0100-12, written without dashes as 80070010012. 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 80070-0100-12, the first segment (80070) is the labeler code FDA assigned to Foundation Consumer Brands; the middle segment (0100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 Foundation Consumer Brands. Listing status can change — the directory data on this page refreshes weekly.

Does this product come in other package sizes?

Yes — the FDA directory lists 1 other package presentation of this same product, including 6 tablets (80070-0100-24). Each has its own NDC and its own page — see the package list near the top of this page.

Who lists this product with the FDA?

Foundation Consumer Brands 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 60 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: sneezing itchy, watery eyes runny nose itching of the nose or throat temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 48 words ▾

Directions do not divide, crush, chew or dissolve the tablet adults and children 12 years and over 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor

⚠️ Warnings 196 words ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have heart disease thyroid disease high blood pressure diabetes trouble urinating due to an enlarged prostate gland liver or kidney disease.

Your doctor should determine if you need a different dose. When using this product do not take more than directed. Taking more than directed may cause drowsiness.

Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever nervousness, dizziness or sleeplessness occurs 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).

📦 Storage and Handling 21 words ▾

Other information each tablet contains: calcium 25 mg store between 20° to 25°C (68° to 77°F) keep in a dry place

🧪 Active Ingredient 16 words ▾

Active ingredients (in each tablet) Purposes Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate, hypromellose, lactose monohydrate, magnesium stearate, pharmaceutical ink, povidone, titanium dioxide

🎯 Purpose 16 words ▾

Active ingredients (in each tablet) Purposes Loratadine 5 mg Antihistamine Pseudoephedrine sulfate 120 mg Nasal decongestant

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

🔗 Related NDC lookups

🧪 All Loratadine And Pseudoephedrine Sulfate NDCsSame ingredient 🏭 All Foundation labeler NDCsLabeler code 80070 📚 All alpha-Adrenergic Agonist NDCsDrug class