NDC 00113-2007-60 — Allergy and Congestion Relief loratadine

🆔 Identity & classification

FDA NDC (as labeled) 0113-2007-60

Product NDC 0113-2007

11-digit billing NDC 00113200760

NCPDP billing unit EA — each (per item)

RxCUI 1242399

UNII 7AJO3BO7QN, Y9DL7QPE6B

Application # ANDA076050

SPL Set ID b5589371-48bc-44a5-bcab-018a92e22796

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 2018-04-12

Route ORAL

Dosage form TABLET, FILM COATED, EXTENDED RELEASE

Substance LORATADINE; PSEUDOEPHEDRINE SULFATE

GPI-14 43993002597430

GPI class Allergy/Congestion Relief

GCN Seq No 017181

GCN 63570

HICL code 006605

Ingredient (HICL) Loratadine/Pseudoephedrine

HIC1 code Z

Therapeutic class — broad (HIC1) Body As A Whole

HIC2 code Z2

Therapeutic class — intermediate (HIC2) Antihistamines, Antiserotonins, Immunosuppressants

HIC3 code Z2O

Therapeutic class — specific (HIC3) 2Nd Gen Antihistamine And Decongestant Combination

AHFS code 04:08.00.00

AHFS class Second Generation Antihistamines

FDB label name ALLERGY-CONGESTION RLF 12H TAB

FDB brand name Allergy-Congestion Relief 12Hr

Legend status O — Over-the-counter (OTC) drug or device

Why two NDCs? The FDA registers this code as 0113-2007-60 — a 4-4-2 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 labeler segment → 00113-2007-60. 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

LabelerL. Perrigo Company

Application holderPERRIGO PHARMA INTERNATIONAL DAC

FDA applicationANDA076050 (ANDA)

Labeler code00113

First marketedApr 2018

Product typeHuman Otc Drug

Portfolio227 products on file

🔎 All NDCs from L. Perrigo Company

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 ALLERGY-CONGESTION RLF 12H TAB Ingredient Loratadine/Pseudoephedrine

📖 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

Size12 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 ea	Per package
Retail pharmacies payNADAC · weekly	$0.787	$15.75 / 20 tablet
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.

NADAC price history (per ea) — tap or hover for the price & month

▲ Up 5% over the last 24 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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Allergy and Congestion Relief 5 mg/1; 120 mgthis 00113-2007-60	L.	1 tablet	$0.787	—	Availability likely	—
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 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 mg 80070-0100-12	Foundation	6 tablets	—	—	FDA listed	—
loratadine D 5 mg/1; 120 mg 85766-0047-10	Sportpharm	1 tablet	—	—	FDA listed	—
allergy and nasal congestion 5 mg/1; 120 mg 30142-0850-65	Kroger	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

🏛️

2018

On the market since

Apr 2018

📍

2026

Currently FDA-listed

8 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 Allergy and Congestion Relief (this brand).

Top reported reactions

Breast Fibrosis1

Condition Aggravated1

Depressed Mood1

Depressive Symptom1

Drug Interaction1

Drug-disease Interaction1

Headache1

Reporter sex

Female · 100%

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	Per unit	Per pack	Marketing start	Status
00113-2007-46	10 BLISTER PACK in 1 CARTON (0113-2007-46) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	—	—	2018-04-17	Discontinued by firm
00113-2007-60 You're viewing this	20 BLISTER PACK in 1 CARTON (0113-2007-60) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK	$0.7873 / ea	$15.75	2018-04-12	Active

Pack size FAQ

What quantity is in NDC 00113-2007-60?

NDC 00113-2007-60 is listed by the FDA — 20 blister pack in 1 carton / 1 tablet, film coated, extended release in 1 blister pack.

What NDC number is used to bill for this package of Allergy and Congestion Relief loratadine, Pseudoephedrine sulfate 5 mg; 120 mg Tablet, Film Coated, Extended Release?

Bill NDC 00113-2007-60 — the 11-digit billing format is 00113200760. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 69 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 49 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 1 words ▾

Warnings

🧪 Active Ingredient 12 words ▾

Active ingredients (in each tablet) Loratadine 5 mg Pseudoephedrine sulfate 120 mg

🧪 Inactive Ingredients 17 words ▾

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

🎯 Purpose 4 words ▾

Purpose Antihistamine 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, Pseudoephedrine Sulfate NDCsSame ingredient 🏭 All L. labeler NDCsLabeler code 00113 📚 All alpha-Adrenergic Agonist NDCsDrug class

💊 Related drugs in this class

Other drugs that share this product’s specific therapeutic class — 2Nd Gen Antihistamine And Decongestant Combination.

Cetirizine Hcl/Pseudoephedrine 00113-0147-62 Fexofenadine/Pseudoephedrine 00363-0049-10 Desloratadine/Pseudoephedrine 78206-0120-01

Where does this data come from?

Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.