Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine HCl 10 mg Tablet, Film Coated, 18-count — NDC 63868-144-19 (Billing 63868-0144-19)
by CHAIN DRUG MARKETING ASSOCIATION INC · 1 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK
This is a package of 18 tablets of Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine HCl 10 mg Tablet, Film Coated from CHAIN DRUG MARKETING ASSOCIATION INC, marketed since Jan 2005 and currently FDA-listed, this package's marketing is listed to end Jul 2027. It is the main listing for this product, which comes in 2 package sizes.
NDC 63868-0144-19
🏷️ FDA NDC (as labeled)
63868-144-19
billing pads the product segment with a zero
This package
Contains18-count
Pack sizes2 compare ↓
Main listing for product 63868-144 · Also comes in:
18 tablets 63868-144-37
🗂️ 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 →
NDC database record
One package, one record: these facts belong to NDC 63868-144-19 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 63868 labeler · 144 product · 19 package
- Package marketed since
- Jan 14, 2005
- Package marketing ended
- Jul 31, 2027
- Sample package
- No — commercial package
- Billing quantity
- 18 EA per package
- Barcode (UPC)
- 0635515954991
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
63868-144-19
Product NDC
63868-144
11-digit billing NDC
63868014419
NCPDP billing unit
EA — each (per item)
RxCUI
1049182
UNII
04JA59TNSJ
UPC
0635515954991
Application #
M012
SPL Set ID
bf7246c1-90fe-4de8-8bb2-e5ff7e8ca63d
Established class (EPC)
alpha-1 Adrenergic Agonist
Mechanism of action
Adrenergic alpha1-Agonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH DRUG
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2005-01-14
Marketing end
2027-11-30
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
PHENYLEPHRINE HYDROCHLORIDE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
42101040100310
GPI class
QC Nasal Decongestant PE
Quick answers
- GPI-14 (Medi-Span): 42101040100310
- RxCUI (RxNorm): 1049182
Why two NDCs?
The FDA registers this code as 63868-144-19 — 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 → 63868-0144-19. 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 1, 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 alpha-1 Adrenergic Agonist class.
Pharmacologic class
alpha-1 Adrenergic Agonist
Drug family (ATC)
Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works
Adrenergic alpha1-Agonists
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
- It depends on the product. The injection raises low blood pressure during anesthesia and, for some products, septic shock. Eye drops dilate the pupil, nasal products relieve conges...
- Be careful. Over-the-counter phenylephrine should not be used with a prescription MAOI or within 2 weeks of stopping one. If you aren't sure whether your medicine is an MAOI, ask m...
- With the injection, the most common are nausea, vomiting and headache. Call for help right away if you have chest pain, a very slow heartbeat, or pain or skin changes around the IV...
- Stop and talk to a doctor if you get nervousness, dizziness or sleeplessness. Also stop if symptoms last more than 7 days or come with a fever. Don't use more than the label recomm...
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 1, 2026
💬 Questions about Phenylephrine HCl?
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
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.
Try another pack size:
18 tablets
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 3, 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 |
|---|---|---|---|---|
| 63868-0144-19 You're viewing this Main listing | 1 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK | 2005-01-14 | Jul 31, 2027 | Active |
| 63868-0144-37 63868-144-37 | 2 BLISTER PACK in 1 CARTON / 18 TABLET, FILM COATED in 1 BLISTER PACK | 2005-01-14 | Nov 30, 2027 | Active |
Pack size FAQ
What quantity is in this package?
This is a 18-count package — 1 blister pack in 1 carton / 18 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Nasal Decongestant PE Non-Drowsy Maximum Strength Phenylephrine HCl 10 mg Tablet, Film Coated?
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 |
|---|---|---|---|---|---|---|
| Nasal Decongestant PE Maximum Strength 10 mg 70677-1152-01 | Strategic | 18 tablets | $0.050 | — | Availability likely | — |
| Nasal Decongestant PE 10 mg 00363-4531-07 | Walgreen | 18 tablets | — | — | FDA listed | — |
| PhysiciansCare Sinus Non-Drowsy 10 mg 00924-0133-01 | Acme | 1 tablet | — | — | FDA listed | — |
| Sinus Pressure and Congestion Relief PE Maximum Strength 10 mg 11822-4530-02 | Rite | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 21130-0453-07 | Better | 18 tablets | — | — | FDA listed | — |
| Sinus Decongestion PE 10 mg 30142-0534-07 | Kroger | 18 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 30142-0853-07 | Kroger | 18 tablets | — | — | FDA listed | — |
| PE Sinus Congestion 10 mg 36800-0704-07 | Topco | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 37808-0453-23 | H | 24 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 37835-0651-01 | Bi-Mart | 100 tablets | — | — | FDA listed | — |
| Medi-First Sinus Decongestant 10 mg 47682-0809-13 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Medi-First Plus Sinus Decongestant 10 mg 47682-0990-33 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Unishield Sinus Decongestant 10 mg 49314-2083-03 | Unishield | 1 tablet | — | — | FDA listed | — |
| Pseudo Time Pe 10 mg 49483-0234-00 | TIME | 100000 tablets | — | — | FDA listed | — |
| Good Sense Nasal Decongestant PE 10 mg 50090-3659-00 | A-S | 36 tablets | — | — | FDA listed | — |
| Phenylephrine HCl Maximum Strength 10 mg 50090-5606-00 | A-S | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant Pe 10 mg 50090-7449-00 | A-S | 18 tablets | — | — | FDA listed | — |
| Sudafed PE Sinus Congestion 10 mg 50580-0437-01 | Kenvue | 18 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 50844-0493-08 | L.N.K. | 24 tablets | — | — | FDA listed | — |
| Suphedrine PE Sinus Congestion Non-Drowsy 10 mg 55301-0753-23 | ARMY | 24 tablets | — | — | FDA listed | — |
| SU PHEDRINE PE Non-Drowsy, Maximum Strength 10 mg 57243-0453-44 | Salado | 18 tablets | — | — | FDA listed | — |
| Su Phedrine Pe Sinus Congestion 10 mg 57243-0953-44 | Salado | 18 tablets | — | — | FDA listed | — |
| Phenylephrine Hydrochloride 10 mg 57631-0018-00 | InvaTech | 30000 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Non-Drowsy Maximum Strength 10 mgthis 63868-0144-19 | CHAIN | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength 10 mg 67091-0207-18 | WinCo | 18 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength Non-Drowsy 10 mg 69168-0272-17 | Allegiant | 300 tablets | — | — | FDA listed | — |
| Redicare Nasal and Sinus Decongestant 10 mg 71105-0272-02 | Redicare | 100 tablets | — | — | FDA listed | — |
| Gencare-Nasal Decongestant PE 10 mg 72090-0025-01 | Pioneer | 300 tablets | — | — | FDA listed | — |
| Gencare-Nasal Decongestant PE 10 mg 72090-0039-01 | Pioneer | 300 tablets | — | — | FDA listed | — |
| Crane Safety Sinus Decongestant 10 mg 73408-0990-33 | Crane | 1 tablet | — | — | FDA listed | — |
| ValuMeds Nasal Decongestant Phenylephrine HCl 10 mg 82725-1111-01 | Cabinet | 300 tablets | — | — | FDA listed | — |
| Goodmeds Non-Drowsy Nasal Decongestant PE 10 mg 82725-4111-01 | Cabinet | 365 tablets | — | — | FDA listed | — |
| Sinus Congestion 10 mg 83324-0073-18 | Chain | 18 tablets | — | — | FDA listed | — |
| Phenylephrine Hydrochloride 10 mg 83586-0010-00 | HHH | 130000 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 83586-0160-01 | HHH | 100 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE 10 mg 84324-0010-01 | NUVICARE | 100 tablets | — | — | FDA listed | — |
| Nasal Decongestant PE Maximum Strength 10 mg 85766-0178-18 | Sportpharm | 18 tablets | — | — | FDA listed | — |
| Medi-First Plus Sinus Decongestant 10 mg 85766-0182-01 | Sportpharm | 1 tablet | — | — | FDA listed | — |
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.
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
🏛️
2005
On the market since
Jan 2005
📍
2026
Currently FDA-listed
21 years listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found
We did not find an FDA-approved generic match for this exact strength, form and route.
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
red
ShapeRound
Imprint44;453
Size7 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 1, 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.
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.- FDA label on DailyMed · label index refreshed Oct 1, 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
LabelerCHAIN DRUG MARKETING ASSOCIATION INC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code63868
First marketedJan 2005
Product typeHuman Otc Drug
Portfolio70 products on file
More NDCs from CHAIN DRUG MARKETING ASSOCIATION INC labeler code 63868
- Pain Relief PM Extra Strength Acetaminophen, Diphenhydramine HCl 500 mg; 25 mg Tablet, Coated NDC 63868-119-50
- Dye Free Allergy childrens Diphenhydramine Hydrochloride 12.5 mg/5mL Liquid NDC 63868-128-04
- QC Regular Strength Antacid 500 mg Tablet, Chewable NDC 63868-130-66
- Quality Choice Cetirizine Hydrochloride 10 mg Tablet NDC 63868-132-14
- Cold and Flu Nighttime Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate 650 mg/30mL; 30 mg/30mL; 12.5 mg/30mL Liquid NDC 63868-140-08
- Pseudoephedrine Hydrochloride 120 mg Tablet, Film Coated, Extended Release NDC 63868-143-10
- Maximum Strength Mucus Relief Guaifenesin 1200 mg Tablet, Extended Release NDC 63868-148-14
- 12 Hour Mucus Relief Guaifenesin 600 mg Tablet, Extended Release NDC 63868-149-20
- Loratadine 10 mg Tablet NDC 63868-151-01
- Quality Choice Extra Strength Assorted Berry Antacid Extra strength Assorted Berry Antacid Calcium carbonate 750 mg Tablet, Chewable NDC 63868-155-96
- CDMA Fiber Therapy Methylcellulose 500 mg Tablet NDC 63868-166-10
- QC Pink Bismuth Bismuth Subsalicylate 262 mg Tablet, Film Coated NDC 63868-171-40
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
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies temporarily relieves sinus congestion and pressure
⏱️ Dosage and Administration ▾
Directions adults and children 12 years and over: take 1 tablet every 4 hours. Do not take more than 6 tablets in 24 hours. children under 12 years: ask a doctor
⚠️ Warnings ▾
Warnings Do not use 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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland When using this product do not exceed recommended dosage.
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever If pregnant or breast-feeding, 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.
📦 Storage and Handling ▾
Other information TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Phenylephrine HCl 10 mg
🧪 Inactive Ingredients ▾
Inactive ingredients croscarmellose sodium, dextrose monohydrate, dibasic calcium phosphate dihydrate, FD&C red #40, lecithin, magnesium stearate, maltodextrin, microcrystalline cellulose, silicon dioxide, sodium carboxymethylcellulose, sodium citrate dihydrate, titanium dioxide
🎯 Purpose ▾
Purpose Nasal decongestant
📄 Do Not Use ▾
Do not use 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 diabetes thyroid disease high blood pressure difficulty in urination due to enlargement of the prostate gland
📄 When Using This Product ▾
When using this product do not exceed recommended dosage.
📄 Stop Use and Ask a Doctor If ▾
Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur symptoms do not improve within 7 days or occur with fever
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, 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.
📄 Questions or Comments ▾
Questions or comments? 1-800-426-9391
📄 Package Label / Principal Display Panel ▾
Principal Display Panel QC® QUALITY CHOICE NDC 63868-144-19 *Compare to the Active Ingredient in SUDAFED PE® SINUS CONGESTION Non-Drowsy | Maximum Strength Nasal Decongestant PE Phenylephrine HCl 10 mg | Nasal Decongestant Sinus Pressure & Congestion Relief Does Not Include Pseudoephedrine 18 Tablets actual size TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING *This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark SUDAFED PE® SINUS CONGESTION.
50844 REV0820C45344 Distributed by C.D.M.A., Inc.© 43157 W 9 Mile Rd Novi, MI 48375 www.qualitychoice.com Questions: 800-935-2362 Quality Choice 44-453 Quality Choice 44-453
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 ↗
Medicare Part D spend CMS · PART D · 2026 (Q1)
Medicare Part D (outpatient prescription) spending for Phenylephrine HCl (matched by generic name) — the program that covers self-administered drugs. 4 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Phenylephrine HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.7K
Claims incl. refills
148
Beneficiaries
134
Spend / beneficiary
$27.89
Spend / claim
$25.25
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
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 Nasal Decongestant PE Non-Drowsy Maximum Strength (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 47%
Female · 53%
Unknown · 0%
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 | — 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
Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
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 it is currently marketed — but CHAIN DRUG MARKETING ASSOCIATION INC has reported a marketing end date of 2027-11-30, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 18 tablets (63868-0144-37). 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?
CHAIN DRUG MARKETING ASSOCIATION 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.
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.