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signature care allergy relief d cetirizine hydrochloride, pseudoephedrine hydrochloride 5 mg; 120 mg Tablet, Film Coated, Extended Release — NDC 21130-644-62 (Billing 21130-0644-62)

by Safeway · 24 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of signature care allergy relief d cetirizine hydrochloride, pseudoephedrine hydrochloride 5 mg; 120 mg Tablet, Film Coated, Extended Release from Safeway, marketed since Feb 2021 and currently FDA-listed. It is this product's only package size.

NDC 21130-0644-62
🏷️ FDA NDC (as labeled) 21130-644-62 billing pads the product segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 21130-644-62
Product NDC 21130-644
11-digit billing NDC 21130064462
RxCUI 1014571
UNII 64O047KTOA, 6V9V2RYJ8N
Application # ANDA210719
SPL Set ID 8f2bcfe7-aac3-4a57-8ebb-c6f8a5829c80
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 2021-02-16
Route ORAL
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Substance CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1014571
Why two NDCs? The FDA registers this code as 21130-644-62 — 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 → 21130-0644-62. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • Great question. It's a two-in-one product. Cetirizine is an antihistamine that targets allergy symptoms like runny nose, sneezing, and itchy, watery eyes. Pseudoephedrine is a deco...
  • What exactly does this medication do — why does it have two ingredients?
  • No — please don't. These are extended-release tablets, which means they're specially designed to release medication slowly over 12 hours. Breaking or chewing the tablet can dump to...
  • Can I break the tablet in half if it's hard to swallow?
📖 Read our full Cetirizine / Pseudoephedrine 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 eachPer 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
21130-0644-62 You're viewing this Main listing 24 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK 2021-02-16 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
All Day Allergy D 5 mg/1; 120 mg 00113-2147-62 L. 1 tablet $0.563 — Availability likely —
Rugby Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride 5 mg/1; 120 mg 00536-1279-12 Rugby 1 tablet $0.563 — Availability likely —
Cetirizine hydrochloride and Pseudoephedrine hydrochloride 5 mg/1; 120 mg 45802-0147-53 Padagis 1 tablet $0.563 — Availability likely —
good neighbor pharmacy all day allergy d 5 mg/1; 120 mg 46122-0626-62 Amerisource 1 tablet $0.563 — Availability likely —
Leader Allergy Relief D 5 mg/1; 120 mg 70000-0042-01 Cardinal 1 tablet $0.563 — Availability likely —
Allergy relief-D 5 mg/1; 120 mg 70677-1020-01 STRATEGIC 6 tablets $0.563 — Availability likely —
Foster And Thrive All Day Allergy D 5 mg/1; 120 mg 70677-1311-01 Strategic 1 tablet $0.563 — 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 mgthis 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 mg 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 —
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
Feb 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.

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.

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

LabelerSafeway
Application holderPERRIGO PHARMA INTERNATIONAL DAC
FDA applicationANDA210719 (ANDA)
Labeler code21130
First marketedFeb 2021
Product typeHuman Otc Drug
Portfolio159 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.

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist 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 📄 Other Information 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 55 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 • nasal congestion • reduces swelling of nasal passages • temporarily relieves sinus congestion and pressure • temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 60 words ▾

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 ~1 min read ▾

Warnings Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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 • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease.

Your doctor should determine if you need a different dose. Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives. When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery Stop use and ask a doctor if • an allergic reaction to this product occurs.

Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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)

🧪 Active Ingredient 15 words ▾

Active ingredients (in each extended release tablet) Cetirizine HCl 5 mg Pseudoephedrine HCl 120 mg

🧪 Inactive Ingredients 22 words ▾

Inactive ingredients colloidal silicon dioxide, hypromellose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 79 words ▾

Do not use • if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine. • 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 46 words ▾

Ask a doctor before use if you have • heart disease • thyroid disease • diabetes • glaucoma • high blood pressure • trouble urinating due to an enlarged prostate gland • liver or kidney disease. Your doctor should determine if you need a different dose.

📄 Ask a Doctor or Pharmacist Before Use If 14 words ▾

Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives.

📄 When Using This Product 38 words ▾

When using this product • do not use more than directed • drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery

📄 Stop Use and Ask a Doctor If 40 words ▾

Stop use and ask a doctor if • an allergic reaction to this product occurs. Seek medical help right away. • you get nervous, dizzy, or sleepless • symptoms do not improve within 7 days or are accompanied by fever

🤰 If Pregnant or Breast-Feeding 18 words ▾

If pregnant or breast-feeding: • if breast-feeding: not recommended • if pregnant: 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 right away. (1-800-222-1222)

📄 Other Information 38 words ▾

Other information • store between 20° to 25°C (68° to 77°F) • do not use if blister unit is broken or torn • see side panel for lot number and expiration date • meets USP Dissolution Test 2

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-719-9260

📄 Package Label / Principal Display Panel 69 words ▾

Package/Label Principal Display Panel Compare to Zyrtec-D® active ingredients Signature care® Quality Guaranteed 12 HOUR ALLERGY + SINUS ORIGINAL PRESCRIPTION STRENGTH Allergy Relief-D CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE EXTENDED RELEASE TABLETS, 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor + Outdoor Allergies Actual Size 12 Hour Relief • Sneezing • Itchy, Watery Eyes • Runny Nose • Itchy Nose or Throat NASAL CONGESTION + SINUS PRESSURE 24 EXTENDED RELEASE TABLETS signature-care-allergy-relief-d-carton-image.jpg

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
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.
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.
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 Safeway. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Safeway 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.
← 21130-0640-03 · SAFEWAY 21130-0646-20 · SAFEWAY →
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.