Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release — NDC 58602-703-53 (Billing 58602-0703-53)
by Aurohealth LLC · 12 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
This is a package of Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release from Aurohealth LLC, marketed since Mar 2023 and currently FDA-listed.
NDC 58602-0703-53
🏷️ FDA NDC (as labeled)
58602-703-53
billing pads the product segment with a zero
This package
Contains1 tablet, film coated, extended release in 1 blister pack
Pack sizes4 compare ↓
Product page 58602-0703-09
Also comes in:
2 tablets 58602-703-09
6 tablets 58602-703-75
6 tablets 58602-703-76
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 17, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 58602-703-53 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 58602 labeler · 703 product · 53 package
- Package marketed since
- Mar 8, 2023
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 5860270353 0
- FDA record last changed
- Sep 17, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
58602-703-53
Product NDC
58602-703
11-digit billing NDC
58602070353
RxCUI
1014571
UNII
64O047KTOA, 6V9V2RYJ8N
Application #
ANDA212409
SPL Set ID
26f2c3c1-a2f2-474a-950a-8cfe07f289fa
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
2023-03-08
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 58602-703-53 — 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 → 58602-0703-53. 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
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.
- RxClass (NLM) · catalog refreshed Oct 1, 2026
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?
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
💬 Questions about Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride?
Ask a pharmacist →
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. | |
ℹ️
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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 5, 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 |
|---|---|---|---|---|
| 58602-0703-09 58602-703-09 Main listing | 12 BLISTER PACK in 1 CARTON / 2 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2023-03-08 | — | Active |
| 58602-0703-53 You're viewing this | 12 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2023-03-08 | — | Active |
| 58602-0703-75 58602-703-75 | 2 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2023-03-08 | — | Active |
| 58602-0703-76 58602-703-76 | 4 BLISTER PACK in 1 CARTON / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK | 2023-03-08 | — | Active |
Pack size FAQ
What quantity is in this package?
This package is listed by the FDA — 12 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 Cetirizine Hydrochloride and Pseudoephedrine 5 mg; 120 mg Tablet, Film Coated, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.
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 | $0.563 | — | 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 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 mgthis 58602-0703-53 | Aurohealth | 1 tablet | — | — | 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 | — |
| 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.
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2023
On the market since
Mar 2023
📍
2026
Currently FDA-listed
3 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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
Yellow
ShapeRound
ImprintK15
Size1 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.
- FDA label on DailyMed · label index refreshed Oct 5, 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 / Pseudoephedrine 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.
-
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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
-
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 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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
6 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescolloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India
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.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
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
LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA212409 (ANDA)
Labeler code58602
First marketedMar 2023
Product typeHuman Otc Drug
Portfolio178 products on file
More NDCs from Aurohealth LLC labeler code 58602
- DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, Extended Release NDC 58602-611-05
- Minoxidil 5% (FOR Men) 50 mg/g Aerosol, Foam NDC 58602-614-23
- DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, Extended Release NDC 58602-617-05
- DEXTROMETHORPHAN POLISTIREX 30 mg/5mL Suspension, Extended Release NDC 58602-618-05
- Loperamide Hydrochloride 2 mg Tablet NDC 58602-701-01
- Loratadine 10 mg Tablet NDC 58602-702-04
- Famotidine 10 mg Tablet, Film Coated NDC 58602-705-09
- Famotidine 20 mg Tablet, Film Coated NDC 58602-706-14
- Esomeprazole Magnesium 20 mg Capsule, Delayed Release NDC 58602-707-05
- Ibuprofen 200 mg Tablet NDC 58602-708-01
- Fem Choice morning after Levonorgestrel 1.5 mg Tablet NDC 58602-712-28
- Ibuprofen 200 mg Tablet NDC 58602-713-01
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 openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
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
📄 Do Not Use
📄 Ask a Doctor 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
📄 Package Label / Principal Display Panel
🎯 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 individual blister units are torn or broken
🧪 Active Ingredient ▾
Drug Facts Active ingredients (in each extended release tablet) Cetirizine HCl USP 5 mg Pseudoephedrine HCl USP 120 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferric oxide, hypromellose, magnesium stearate, microcrystalline cellulose. Questions or comments? call 1-855-274-4122 (Monday - Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India
🎯 Purpose ▾
Purpose Antihistamine Nasal decongestant
📄 Do Not Use ▾
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 ▾
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 ▾
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 in rare cases, you may experience itching after stopping cetirizine. Consult your healthcare provider if this happens.
📄 Stop Use and Ask a Doctor If ▾
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 pregnant or breast-feeding: if breast-feeding: not recommended if pregnant: ask a health professional before use.
📄 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 ▾
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton AUROHEALTH NDC 58602-703-09 *Compare to the active ingredients of Zyrtec-D ® Original Prescription Strength Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets, USP 5 mg/120 mg Antihistamine/Nasal Decongestant Indoor & Outdoor Allergies ALLERY + SINUS NASAL CONGESTION + SINUS PRESSURE 12 Hour relief of Sneezing Runny Nose Itchy, Watery Eyes Itchy Throat or Nose Actual Size 24 EXTENDED-RELEASE TABLETS PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -5 mg/120 mg (12 x 2) Blister Carton
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 ↗
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 Cetirizine hydrochloride and pseudoephedrine hydrochloride — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 23%
Female · 77%
Serious outcomes
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.
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 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 Aurohealth LLC. 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 2 tablets (58602-0703-09), 6 tablets (58602-0703-75), 6 tablets (58602-0703-76). 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?
Aurohealth LLC 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.
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.