Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release
by Sun Pharmaceutical Industries, Inc. · 2 BLISTER PACK in 1 CARTON (62756-915-62) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60)
NDC 62756-0915-62
🏷️ FDA NDC (as labeled)
62756-915-62
billing pads the product segment with a zero
This package
Contains6 tablet, film coated, extended release in 1 blister pack
Pack sizes4 compare ↓
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 →
🆔 Identity & classification
FDA NDC (as labeled)
62756-915-62
Product NDC
62756-915
11-digit billing NDC
62756091562
RxCUI
1014571
UNII
64O047KTOA, 6V9V2RYJ8N
Application #
ANDA090922
SPL Set ID
796c4b81-145b-4050-a851-dec81ff97006
Established class (EPC)
Histamine-1 Receptor Antagonist; alpha-Adrenergic Agonist
Mechanism of action
Adrenergic alpha-Agonists; Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
ANDA
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2012-09-29
Route
ORAL
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Substance
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Why two NDCs?
The FDA registers this code as 62756-915-62 — 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 → 62756-0915-62. 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)
Piperazine derivatives, Other antiallergics
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
LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA090922 (ANDA)
Labeler code62756
First marketedSep 2012
Product typeHuman Otc Drug
Portfolio889 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
Cetirizine injection is used to treat acute urticaria (sudden appearance of hives). Cetirizine 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. Cetirizine is an antihistamine that tackles the classic allergy symptoms — the sneezing, runny nose, itchy eyes, and throat irritation. Pseudoephedrine is a deconge...
- What exactly does this medicine do — why does it have two ingredients?
- Yes, drowsiness is a real possibility with this combination. The cetirizine component can make you sleepy, and that effect gets worse if you drink alcohol or take any sedatives or...
- Can this make me feel drowsy? I need to drive.
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 Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
-
UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
-
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
-
UNII T4V6TWG28D
A plant-derived thickening agent made from cellulose. It increases viscosity and helps form a gel or paste consistency in medications, and may serve as a binder or coating material in various formulations.
-
UNII RFW2ET671P
Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
-
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.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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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 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 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
-
UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
-
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.
13 inactive ingredients listed in the exact product block matched to this NDC.
The official label also stateshydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
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 |
|---|---|---|---|---|---|---|
| All Day Allergy D 5 mg/1; 120 mg 00113-2147-62 | L. | 1 tablet | $0.578 | — | Availability likely | — |
| Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 00536-1279-12 | Rugby | 1 tablet | $0.578 | — | Availability likely | — |
| Cetirizine hydrochloride and Pseudoephedrine hydrochloride 5 mg/1; 120 mg 45802-0147-53 | Padagis | 1 tablet | $0.578 | — | Availability likely | — |
| good neighbor pharmacy all day allergy d 5 mg/1; 120 mg 46122-0626-62 | Amerisource | 1 tablet | $0.578 | — | Availability likely | — |
| Leader Allergy Relief D 5 mg/1; 120 mg 70000-0042-01 | Cardinal | 1 tablet | $0.578 | — | Availability likely | — |
| Allergy relief-D 5 mg/1; 120 mg 70677-1020-01 | STRATEGIC | 6 tablets | $0.578 | — | Availability likely | — |
| Foster And Thrive All Day Allergy D 5 mg/1; 120 mg 70677-1311-01 | Strategic | 1 tablet | $0.578 | — | Availability likely | — |
| good sense all day allergy d 5 mg/1; 120 mg 00113-0147-53 | L. | 1 tablet | — | — | Discontinued | — |
| Wal-Zyr D 5 mg/1; 120 mg 00363-0989-12 | Walgreen | 6 tablets | — | — | FDA listed | — |
| allergy relief D12 5 mg/1; 120 mg 00363-4923-53 | Walgreen | 1 tablet | — | — | FDA listed | — |
| allergy relief-D 5 mg/1; 120 mg 11822-3009-00 | Rite | 1 tablet | — | — | FDA listed | — |
| Allergy relief-D 5 mg/1; 120 mg 11822-9994-01 | RITE | 6 tablets | — | — | FDA listed | — |
| signature care allergy relief d 5 mg/1; 120 mg 21130-0644-62 | Safeway | 1 tablet | — | — | FDA listed | — |
| all day allergy d 5 mg/1; 120 mg 30142-0450-62 | Kroger | 1 tablet | — | — | FDA listed | — |
| Allergy and Sinus Relief 5 mg/1; 120 mg 30142-0633-62 | Kroger | 1 tablet | — | — | FDA listed | — |
| topcare all day allergy d 5 mg/1; 120 mg 36800-0744-62 | Topco | 1 tablet | — | — | FDA listed | — |
| allergy relief d 5 mg/1; 120 mg 37808-0651-53 | H | 1 tablet | — | — | FDA listed | — |
| 12 hour allergy d 5 mg/1; 120 mg 41250-0728-53 | Meijer | 1 tablet | — | — | FDA listed | — |
| Zyrtec-D 5 mg/1; 120 mg 50580-0719-12 | Kenvue | 6 tablets | — | — | FDA listed | — |
| ZYRTEC-D Allergy Plus Congestion 5 mg/1; 120 mg 50580-0728-12 | Kenvue | 6 tablets | — | — | FDA listed | — |
| Allergy Relief D12 5 mg/1; 120 mg 51316-0607-53 | CVS | 1 tablet | — | — | FDA listed | — |
| Allergy relief-D 5 mg/1; 120 mg 51660-0940-12 | Ohm | 6 tablets | — | — | FDA listed | — |
| allergy relief d 5 mg/1; 120 mg 56062-0147-53 | Publix | 1 tablet | — | — | FDA listed | — |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 58602-0703-09 | Aurohealth | 2 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mgthis 62756-0915-62 | Sun | 6 tablets | — | — | FDA listed | — |
| kirkland signature aller tec d 5 mg/1; 120 mg 63981-0147-62 | Costco | 1 tablet | — | — | FDA listed | — |
| Allergy relief-D 5 mg/1; 120 mg 68016-0531-24 | CHAIN | 24 tablets | — | — | FDA listed | — |
| allergy relief d 5 mg/1; 120 mg 69842-0415-53 | CVS | 1 tablet | — | — | FDA listed | — |
| Allergy Relief-D 5 mg/1; 120 mg 69842-0994-12 | CVS | 6 tablets | — | — | FDA listed | — |
| equate allergy relief d nasal decongestant 5 mg/1; 120 mg 79903-0126-14 | WALMART | 1 tablet | — | — | FDA listed | — |
| Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 29300-0313-22 | Unichem | 6 tablets | — | — | 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
🏛️
2012
On the market since
Sep 2012
📍
2026
Currently FDA-listed
14 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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 62756-0915-62 You're viewing this | 2 BLISTER PACK in 1 CARTON (62756-915-62) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) | 2012-09-29 | Active |
| 62756-0915-63 | 1 BLISTER PACK in 1 CARTON (62756-915-63) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) | 2012-09-29 | Active |
| 62756-0915-73 | 4 BLISTER PACK in 1 CARTON (62756-915-73) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (62756-915-60) | 2012-09-29 | Active |
| 62756-0915-83 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62756-915-83) | 2012-09-29 | Active |
Pack size FAQ
What quantity is in NDC 62756-0915-62?
NDC 62756-0915-62 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 Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release?
Bill NDC 62756-0915-62 — the 11-digit billing format is 62756091562. 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 | ✓ 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
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 62756-915-62, 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: 62756-0915-62, written without dashes as 62756091562. 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 62756-0915-62, the first segment (62756) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (0915) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (62) 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 Sun Pharmaceutical Industries, Inc.. 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 3 other package presentations of this same product, including 6 tablets (62756-0915-63), 6 tablets (62756-0915-73), 30 tablets (62756-0915-83). 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?
Sun Pharmaceutical Industries, Inc. 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 ▾
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 nasal congestion reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose
⏱️ Dosage and Administration ▾
Directions do not break or chew tablet; swallow tablet whole adults and children 12 years and over take 1 tablet every 12 hours; do not take more than 2 tablets in 24 hours. adults 65 years and over ask a doctor children under 12 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️ Warnings ▾
Warnings
📦 Storage and Handling ▾
Other information store between 20° to 25°C (68° to 77°F) Do not use if carton is opened or if the blister unit is broken See side panel for lot number and expiration date
🧪 Active Ingredient ▾
Active ingredients Cetirizine HCl, USP 5 mg Pseudoephedrine HCl, USP 120 mg
🧪 Inactive Ingredients ▾
Inactive ingredients hydroxyethyl cellulose, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, stearic acid, titanium dioxide Imprinting Ink Contents: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol, shellac glaze
🎯 Purpose ▾
Purposes Antihistamine Nasal decongestant
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.