Cetirizine Hydrochloride Tablets, 5 mg 5 mg Tablet, 100-count — NDC 25000-219-08 (Billing 25000-0219-08)
This is a package of 100 tablets of Cetirizine Hydrochloride Tablets, 5 mg 5 mg Tablet from MARKSANS PHARMA LIMITED, marketed since Jan 2022 and currently FDA-listed.
NDC database record
One package, one record: these facts belong to NDC 25000-219-08 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 25000 labeler · 219 product · 08 package
- Package marketed since
- Jan 13, 2022
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC)
- 0325000160814, 0325000219147, 0325000219086, 0325000160036 +7 more
- FDA record last changed
- Jul 24, 2026
Other active recalls for Cetirizine Hydrochloride (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
- RxCUI (RxNorm): 1014676
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It relieves allergy symptoms. Over-the-counter versions ease runny nose, sneezing, itchy, watery eyes and an itchy nose or throat from hay fever. Specific products treat hives, yea...
- It can. Drowsiness was reported, and it was more common at higher doses in children. Be careful driving or using machinery until you know how it affects you, and avoid alcohol.
- The oral solution can be taken with or without food. Food slightly delays how fast it works but does not change how much your body absorbs.
- Check with me first if you take sedatives or tranquilizers, since they can add to drowsiness. The label found no significant interactions with azithromycin, pseudoephedrine, ketoco...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Cetirizine Hydrochloride — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 25000-0219-03 25000-219-03 Main listing | 1 BOTTLE in 1 CARTON / 30 TABLET in 1 BOTTLE | 2022-01-13 | — | Active |
| 25000-0219-08 You're viewing this | 1 BOTTLE in 1 CARTON / 100 TABLET in 1 BOTTLE | 2022-01-13 | — | Active |
| 25000-0219-14 25000-219-14 | 1000 TABLET in 1 BOTTLE | 2022-01-13 | — | Active |
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 25000-0219-03?
What NDC number is used to bill for this package of Cetirizine Hydrochloride Tablets, 5 mg 5 mg Tablet?
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride 5 mg 00378-3635-01 | Mylan | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride 5 mg 16571-0401-10 | Rising | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride 5 mg 49483-0682-01 | TIME | 100 tablets | $0.048 | — | Availability likely | — |
| Cetirizine Hydrochloride Tablets, 5 mgthis 25000-0219-08 | MARKSANS | 100 tablets | — | — | FDA listed | — |
| Zyrtec Allergy 5 mg 50580-0754-15 | Kenvue | 1 tablet | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Allergy) 5 mg 58602-0444-09 | Aurohealth | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride (Hives Relief) 5 mg 58602-0446-09 | Aurohealth | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 63629-4914-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 65162-0045-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride Hives Relief 5 mg 65162-0145-03 | Amneal | 30 tablets | — | — | FDA listed | — |
| Cetirizine Hydrochloride 5 mg 71205-0093-15 | Proficient | 15 tablets | — | — | FDA listed | — |
| Cetirizine HCl 5 mg 72657-0128-03 | GLENMARK | 300 tablets | — | — | FDA listed | — |
| Cetirizine HCl 72657-0130-05 | GLENMARK | 90 tablets | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
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?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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 Cetirizine 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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 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.
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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.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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UNII U725QWY32X
Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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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.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from MARKSANS PHARMA LIMITED labeler code 25000
- Pregabalin 75 mg Capsule NDC 25000-181-07
- Pregabalin 100 mg Capsule NDC 25000-182-07
- Pregabalin 150 mg Capsule NDC 25000-183-07
- Pregabalin 200 mg Capsule NDC 25000-184-07
- Pregabalin 225 mg Capsule NDC 25000-185-07
- Pregabalin 300 mg Capsule NDC 25000-186-07
- Cetirizine Hydrochloride Tablets, 10 mg 10 mg Tablet NDC 25000-220-03
- Duloxetine 20 mg Capsule, Delayed Release NDC 25000-608-06
- Duloxetine 30 mg Capsule, Delayed Release NDC 25000-609-03
- Duloxetine 60 mg Capsule, Delayed Release NDC 25000-610-03
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
FDA label — Drug Facts FDA SPL
🎯 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
⏱️ Dosage and Administration ▾
Directions For 5 mg: adults and children 6 years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours adults 65 years and ove r 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor For 10 mg: adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours.
A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor
⚠️ Warnings ▾
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. Ask a doctor before use if you have 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 drowsiness may occur avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away. If pregnant or breast-feeding if breast-feeding: not recommended if pregnant: ask a health professional before use.
🧪 Active Ingredient ▾
Active ingredient (in each tablet) For 5 mg: Cetirizine HCl USP 5 mg For 10 mg: Cetirizine HCl USP 10 mg For 10 mg (Oval Shape): Cetirizine HCl USP 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, titanium dioxide Questions or comments? Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
🎯 Purpose ▾
Purpose Antihistamine
📄 Keep Out of Reach of Children ▾
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)
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count bottle label NDC 25000-219-03 Cetirizine Hydrochloride Tablets USP, 5 mg 30s count carton label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count bottle label NDC 25000-219-08 Cetirizine Hydrochloride Tablets USP, 5 mg 100s count carton label NDC 25000-219-14 Cetirizine Hydrochloride Tablets USP, 5 mg 1000s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count bottle label NDC 25000-220-03 Cetirizine Hydrochloride Tablets USP, 10 mg 30s count carton label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count bottle label NDC 25000-220-08 Cetirizine Hydrochloride Tablets USP, 10 mg 100s count carton label NDC 25000-220-14 Cetirizine Hydrochloride Tablets USP, 10 mg 1000s count bottle label NDC 25000-220-78 Cetirizine Hydrochloride Tablets USP, 10 mg 7s count carton label NDC 25000-220-81 Cetirizine Hydrochloride Tablets USP, 10 mg 14s count carton label NDC 25000-160-81 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 14s count carton label NDC 25000-160-03 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 30s count carton label NDC 25000-160-03 (Oval Shape) Cetirizine Hydrochloride Tablets USP, 10 mg 30s count bottle label NDC 25000-160-14 Cetirizine Hydrochloride Tablets USP, 10 mg (Oval Shape) 1000s count bottle label cetirizine-hcl-5-mg-30ct-bottle cetirizine-hcl-5-mg-30ct-ifc cetirizine-hcl-5-mg-100ct-bottle cetirizine-hcl-5-mg-100ct-ifc cetirizine-hcl-5-mg-1000ct-bottle cetirizine-hcl-10-mg-30s-bottle cetirizine-hcl-10-mg-30s-ifc cetirizine-hcl-10-mg-100s-bottle cetirizine-hcl-10-mg-100ct-ifc cetirizine-hcl-10-mg-1000s-label cetirizine-hcl-10-mg-7s-ifc cetirizine-hcl-10-mg-14s-ifc cetirizine-hcl-10-mg-oval-14s-carton-label cetirizine-hcl-10-mg-oval-30s-carton cetirizine-hcl-10-mg-oval-30s-label cetirizine-hcl-10-mg-oval-1000s-label
Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
Where does this data come from?
About this NDC listing & data coverage
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. |