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Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy Acetaminophen and Phenylephrine HCl 325 mg; 5 mg Tablet, 18-count — NDC 69168-270-95 (Billing 69168-0270-95)

by Allegiant Health · 18 TABLET in 1 BLISTER PACK

This is a package of 18 tablets of Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy Acetaminophen and Phenylephrine HCl 325 mg; 5 mg Tablet from Allegiant Health, marketed since Dec 2014 and currently FDA-listed, this package's marketing is listed to end Oct 2027. It is this product's only package size.

NDC 69168-0270-95
🏷️ FDA NDC (as labeled) 69168-270-95 billing pads the product segment with a zero
OTC 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

NDC database record

One package, one record: these facts belong to NDC 69168-270-95 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69168 labeler · 270 product · 95 package
Package marketed since
Dec 22, 2014
Package marketing ended
Oct 31, 2027
Sample package
No — commercial package
Barcode (UPC)
0369168270954
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69168-270-95
Product NDC 69168-270
11-digit billing NDC 69168027095
RxCUI 1046378
UNII 362O9ITL9D, 04JA59TNSJ
UPC 0369168270954
Application # M013
SPL Set ID b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f
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 2014-12-22
Marketing end 2027-10-31
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1046378
Why two NDCs? The FDA registers this code as 69168-270-95 — 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 → 69168-0270-95. 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 Anilides class.

Drug family (ATC) Anilides
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

🧪 What is this product?

Sinus Headache PE Maximum Strength is an oral tablet marketed as an over-the-counter monograph product. It contains acetaminophen, a pain reliever and fever reducer, combined with phenylephrine hydrochloride, a nasal decongestant. This combination is typically used to address headache and sinus pressure symptoms that may occur together. The product is formulated to be non-drowsy.

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
69168-0270-95 You're viewing this Main listing 18 TABLET in 1 BLISTER PACK 2014-12-22 Oct 31, 2027 Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Sinus Congestion and Pain Maximum Strength 325 mg/1; 5 mg 00536-1289-35 Rugby 24 tablets $0.085 — Availability likely —
Sinus Pressure Pain Maximum Strength, Non-Drowsy 325 mg/1; 5 mg 46122-0443-62 Amerisource 24 tablets $0.085 — Availability likely —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 70000-0161-01 Cardinal 24 tablets $0.085 — Availability likely —
Sinus and Headache 325 mg/1; 5 mg 70000-0568-01 Cardinal 12 tablets $0.085 — Availability likely —
Sinus plus Headache 325 mg/1; 5 mg 83324-0094-24 CHAIN 12 tablets $0.085 — Availability likely —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-0607-02 Haleon 8 tablets — — FDA listed —
Panadol Cold and Flu NonDrowsy 325 mg/1; 5 mg 00135-7031-01 Haleon 2 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 00363-4066-08 Walgreen 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 11822-4669-08 Rite 12 tablets — — FDA listed —
Sinus Pressure and Pain PE Maximum Strength 325 mg/1; 5 mg 11822-5022-08 Rite 24 tablets — — FDA listed —
Pain Relief Non Drowsy Daytime 325 mg/1; 5 mg 21130-0466-08 Better 12 tablets — — Discontinued —
Pain Relief Sinus Congestion 325 mg/1; 5 mg 21130-0474-08 Better 12 tablets — — FDA listed —
Sinus Relief MAXIMUM STRENGTH 325 mg/1; 5 mg 21130-0502-21 Better 24 tablets — — FDA listed —
Sinus Plus Headache 325 mg/1; 5 mg 30142-0466-08 Kroger 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 36800-0320-06 TOPCO 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 36800-0322-05 TOPCARE 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime Non-Drowsy 325 mg/1; 5 mg 37808-0466-08 H 12 tablets — — FDA listed —
Sinus Congestion and Pain Daytime 325 mg/1; 5 mg 41163-0664-08 United 12 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 42507-0223-05 HYVEE 12 tablets — — FDA listed —
Sinus Pressure and Pain PE 325 mg/1; 5 mg 42507-0320-06 HYVEE 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 50580-0435-01 Kenvue 12 tablets — — FDA listed —
SUDAFED PE Pressure Plus Pain 325 mg/1; 5 mg 50580-0547-25 Kenvue 12 tablets — — FDA listed —
Tylenol Sinus Plus Headache Day 325 mg/1; 5 mg 50580-0598-01 Kenvue 12 tablets — — Discontinued —
Sinus and Headache 325 mg/1; 5 mg 50804-0123-05 GOODSENSE 12 tablets — — FDA listed —
sinus pressure and pain pe 325 mg/1; 5 mg 50804-0220-06 GOODSENSE 12 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mg 50844-0467-02 L.N.K. 12 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0008-01 FORTUNE 24 tablets — — FDA listed —
Coltalin-Nd 325 mg/1; 5 mg 51467-0013-01 FORTUNE 24 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 53943-0220-06 DISCOUNT 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 53943-0323-05 DISCOUNT 12 tablets — — FDA listed —
Sinus Headache and Pain Day, Non-drowsy 325 mg/1; 5 mg 55301-0446-08 ARMY 12 tablets — — FDA listed —
Suphedrine PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 55301-0902-08 ARMY 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 55319-0496-08 Family 12 tablets — — FDA listed —
Sinus Pressure and Pain 325 mg/1; 5 mg 55319-0702-08 Family 24 tablets — — FDA listed —
Sinus and Headache Daytime 325 mg/1; 5 mg 55910-0466-08 DOLGENCORP, 12 tablets — — FDA listed —
Sinus Pressure and Pain Maximum Strength 325 mg/1; 5 mg 55910-0925-08 DOLGENCORP, 24 tablets — — FDA listed —
Sinus and Headache 325 mg/1; 5 mg 57344-0923-05 AAA 12 tablets — — FDA listed —
Sinus Pain And Congestion Daytime 325 mg/1; 5 mg 59779-0466-08 CVS 12 tablets — — FDA listed —
Sinus PE Pressure plus Pain MAXIMUM STRENGTH 325 mg/1; 5 mg 59779-0802-08 CVS 24 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 63868-0582-24 CHAIN 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 63941-0220-06 VALU 12 tablets — — FDA listed —
Nasal Decongestant PE and Pain Relief Maximum Strength 325 mg/1; 5 mg 67091-0209-24 WinCo 24 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy 325 mg/1; 5 mg 67091-0213-24 WinCo 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 68998-0220-06 MARC 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 68998-0323-05 MARC 12 tablets — — FDA listed —
Sinus Headache PEMaximum Strength Non-Drowsy Maximum Strength Non-Drowsy 325 mg/1; 5 mgthis 69168-0270-95 Allegiant 18 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72036-0320-06 Harris 12 tablets — — FDA listed —
Sinus plus Headache 325 mg/1; 5 mg 72036-0323-05 Harris 12 tablets — — FDA listed —
Sinus Pressure plus Pain PE 325 mg/1; 5 mg 72476-0120-06 RETAIL 12 tablets — — FDA listed —
Sinus And Headache 325 mg/1; 5 mg 72476-0123-05 RETAIL 12 tablets — — FDA listed —
Sudafed PE Sinus Pressure Plus Pain 325 mg/1; 5 mg 85766-0183-24 Sportpharm 12 tablets — — FDA listed —
Sinus Congestion and Pain Relief Non-Drowsy, Daytime 325 mg/1; 5 mg 11822-0588-04 Rite 2 tablets — — Discontinued —
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.

Availability & generic status

🏛️
2014
On the market since
Dec 2014
📍
2026
Currently FDA-listed
12 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.

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

LabelerAllegiant Health
FDA applicationM013 (OTC MONOGRAPH DRUG)
Labeler code69168
First marketedDec 2014
Product typeHuman Otc Drug
Portfolio113 products on file

More NDCs from Allegiant Health labeler code 69168

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 and Cautions ⚠️ 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 35 words ▾

Uses temporarily relieves these symptoms associated with hay fever or other upper respiratory allergies, and the common cold: sinus congestion and pressure headache minor aches and pains nasal congestion promotes sinus drainage temporarily reduces fever

⏱️ Dosage and Administration 42 words ▾

Directions do not use more than directed (see overdose warning) adults and children 12 years of age and older: take 2 caplets every 4-6 hours do not take more than 10 caplets in 24 hours children under 12 years: ask a doctor

⚠️ Warnings and Cautions ~1 min read ▾

Liver warning/Allergy alert Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 using this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

⚠️ Warnings ~1 min read ▾

Warnings Liver warning/Allergy alert Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000mg of acetaminophen in 24 hours with other drugs containing acetminophen 3 or more alcoholic drinks every day while using this product Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 using this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

🧪 Active Ingredient 12 words ▾

Active ingredient (in each caplet) Acetaminophen 325 mg Phenylephrine HCl 5 mg

🧪 Inactive Ingredients 22 words ▾

Inactive Ingredients corn starch, crospovidone, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

🎯 Purpose 6 words ▾

Purpose Pain reliever/fever reducer Nasal decongestant

📄 Do Not Use 211 words ▾

Do not use with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. 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 using this product. if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Ask a Doctor Before Use If 116 words ▾

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes trouble urinating due to an enlarged prostate Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Ask a Doctor or Pharmacist Before Use If 91 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 When Using This Product 75 words ▾

When using this product When using this product do not exceed recommended dose Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Stop Use and Ask a Doctor If 62 words ▾

Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur pain or nasal congestion gets worse or lasts more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur You may report side effects to 1-888-952-0050 If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

🤰 If Pregnant or Breast-Feeding 14 words ▾

If pregnant or breast-feeding If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 50 words ▾

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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Package Label / Principal Display Panel 8 words ▾

Package/Label Principal Display Panel Sinus Headache Sinus Headache

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 Acetaminophen and Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Anxiety1
Disturbance In Attention1
Dizziness1
Dry Mouth1
Nervousness1
Suicidal Ideation1

Reporter sex

1 reports
Female · 100%
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 Allegiant Health has reported a marketing end date of 2027-10-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Allegiant Health 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.
← 69168-0263-30 · Allegiant 69168-0271-17 · Allegiant →
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.