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Nasal Decongestant Maximum Strength Pseudoephedrine HCl 30 mg Tablet, Film Coated, 24-count — NDC 68016-0473-24 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nasal Decongestant Maximum Strength Pseudoephedrine HCl 30 mg Tablet, Film Coated, 24-count — NDC 68016-473-24 (Billing 68016-0473-24)

by Chain Drug Consortium · 1 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK

This is a package of 24 tablets of Nasal Decongestant Maximum Strength Pseudoephedrine HCl 30 mg Tablet, Film Coated from Chain Drug Consortium, marketed since Aug 1981 and currently FDA-listed, this package's marketing is listed to end Aug 2027. It is the main listing for this product, which comes in 2 package sizes.

NDC 68016-0473-24
🏷️ FDA NDC (as labeled) 68016-473-24 billing pads the product segment with a zero
This package
Contains24-count Pack sizes2 compare ↓
Main listing for product 68016-473 · Also comes in: 24 tablets 68016-473-96
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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68016-473-24
Product NDC 68016-473
11-digit billing NDC 68016047324
RxCUI 1049160
UNII 6V9V2RYJ8N
UPC 0840986014529
Application # M012
SPL Set ID 270e9221-d305-4148-b523-741e02fe733f
Established class (EPC) alpha-Adrenergic Agonist
Mechanism of action Adrenergic alpha-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 1981-08-25
Marketing end 2027-08-31
Route ORAL
Dosage form TABLET, FILM COATED
Substance PSEUDOEPHEDRINE HYDROCHLORIDE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 005089
GCN 20481
HICL code 002091
Ingredient (HICL) Pseudoephedrine Hcl
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B6
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Cont3)
HIC3 code B6V
Therapeutic class — specific (HIC3) Decongestants, Oral
AHFS code 12:12.12.00
AHFS class Alpha- And Beta-Adrenergic Agonists
FDB label name PV NASAL DECONGEST 30 MG TAB
FDB brand name Nasal Decongestant
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 005089
  • GCN: 20481
  • HICL (First Databank): 002091
  • AHFS class code: 12:12.12.00
  • RxCUI (RxNorm): 1049160
Why two NDCs? The FDA registers this code as 68016-473-24 — 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 → 68016-0473-24. 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 alpha-Adrenergic Agonist class.

Pharmacologic class alpha-Adrenergic Agonist
Drug family (ATC) Sympathomimetics
How it works Adrenergic alpha-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.

Clinical

Label name PV NASAL DECONGEST 30 MG TAB Ingredient Pseudoephedrine Hcl
📖 What it is MedlinePlus · NLM

Pseudoephedrine is used to relieve nasal congestion caused by colds, allergies, and hay fever. It is also used to temporarily relieve sinus congestion and pressure. Pseudoephedrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Pseudoephedrine is in a class of medications called nasal decongestants. It works by causing narrowing of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It temporarily relieves nasal congestion from the common cold, hay fever or other upper respiratory allergies. Many products also relieve sinus congestion and pressure.
  • It depends on the product. Regular tablets and softgels are usually taken every 4 to 6 hours, while 12-hour extended-release tablets are taken every 12 hours. Check your box for th...
  • No. Swallow them whole. Don't divide, crush, chew or dissolve them. Seeing part of the tablet in your stool can happen and is normal.
  • Can I crush or chew the extended-release tablets?
📖 Read our full Pseudoephedrine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 24 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
68016-0473-24 You're viewing this Main listing 1 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK 1981-08-25 Aug 31, 2027 Active
68016-0473-96 68016-473-96 4 BLISTER PACK in 1 CARTON / 24 TABLET, FILM COATED in 1 BLISTER PACK 1981-08-25 Aug 31, 2027 Active

Pack size FAQ

What quantity is in this package?
This is a 24-count package — 1 blister pack in 1 carton / 24 tablet, film coated in 1 blister pack.
What NDC number is used to bill for this package of Nasal Decongestant Maximum Strength Pseudoephedrine HCl 30 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nasal Decongestant 30 mg 00113-0432-62 L. 24 tablets $0.078 — Availability likely —
Nasal Decongestant 30 mg 00536-3607-35 Rugby 24 tablets $0.078 — Availability likely —
SudoGest 30 mg 00904-5053-59 Major 100 tablets $0.078 — Availability likely —
SudoGest Nasal Decongestant 30 mg 00904-6337-24 Major 1 tablet $0.078 — Availability likely —
SudoGest 30 mg 00904-6727-60 Major 100 tablets $0.078 — Availability likely —
Pseudoephedrine HCl 30 mg 00904-6990-61 Major 10 tablets $0.078 — Availability likely —
pseudoephedrine hydrochloride 30 mg 45802-0432-62 Padagis 1 tablet $0.078 — Availability likely —
Nasal Decongestant Maximum Strength, Non-Drowsy 30 mg 46122-0428-62 Amerisource 24 tablets $0.078 — Availability likely —
Leader Nasal Decongestant 30 mg 70000-0002-01 Cardinal 1 tablet $0.078 — Availability likely —
Nasal Decongestant Maximum Strength 30 mg 70677-1017-01 Strategic 24 tablets $0.078 — Availability likely —
Nasal Decongestant D 30 mg 00363-1214-08 Walgreen 24 tablets — — FDA listed —
Sinus Pressure and Congestion Relief Maximum Strength 30 mg 11822-0112-02 Rite 24 tablets — — FDA listed —
Nasal Decongestant Maximum Strength 30 mg 21130-0112-08 Better 24 tablets — — FDA listed —
sinus 30 mg 30142-0613-62 Kroger 1 tablet — — Discontinued —
Sinus Decongestion 30 mg 30142-0641-08 Kroger 24 tablets — — FDA listed —
Topcare Nasal Decongestant Maximum Strength Non Drowsy 30 mg 36800-0432-62 Topco 1 tablet — — FDA listed —
Nasal Decongestant 30 mg 37808-0112-22 H 24 tablets — — FDA listed —
equaline nasal decongestant non drowsy maximum strength 30 mg 41163-0432-67 United 6 tablets — — FDA listed —
nasal decongestant maximum strength non drowsy 30 mg 41250-0432-62 Meijer 1 tablet — — FDA listed —
CareOne Nasal and Sinus Decongestant 30 mg 41520-0881-62 American 12 tablets — — FDA listed —
Sinus and Congestion Non-Drowsy 30 mg 49035-0780-08 Wal-Mart 24 tablets — — FDA listed —
Sudogest 30 mg 50090-1961-00 A-S 28 tablets — — FDA listed —
Sudogest Nasal Decongestant 30 mg 50090-4345-00 A-S 48 tablets — — Discontinued —
pseudoephedrine hydrochloride 30 mg 50090-5615-01 A-S 1 tablet — — FDA listed —
SUDAFED Sinus Congestion 30 mg 50580-0363-01 Kenvue 12 tablets — — FDA listed —
Nasal Decongestant 30 mg 50844-0112-08 L.N.K. 12 tablets — — FDA listed —
Sinus and Nasal Decongestant 30 mg 51316-0121-22 CVS 24 tablets — — FDA listed —
Sinus And Nasal Decongestant 30 mg 51316-0317-62 CVS 12 tablets — — FDA listed —
Nasal Decongestant 30 mg 56062-0432-62 Publix 24 tablets — — FDA listed —
Nasal Decongestant Non-Drowsy 30 mg 59779-0112-08 CVS 24 tablets — — FDA listed —
Nasal Decongestant 30 mg 59779-0432-62 CVS 1 tablet — — FDA listed —
Nasal Decongestant 30 mg 63187-0344-24 Proficient 24 tablets — — FDA listed —
Nasal Decongestant Maximum Strength 30 mg 63868-0802-24 CHAIN 24 tablets — — FDA listed —
Nasal Decongestant Maximum Strength 30 mgthis 68016-0473-24 Chain 24 tablets — — FDA listed —
pseudoephedrine hydrochloride 30 mg 71205-0197-24 Proficient 1 tablet — — FDA listed —
Sinus Congestion 30 mg 83324-0054-24 Chain 24 tablets — — FDA listed —
pseudoephedrine hydrochloride 30 mg 85766-0049-24 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.

Availability & generic status

🏛️
1981
On the market since
Aug 1981
📍
2026
Currently FDA-listed
45 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.

What it looks like

Color red
ShapeRound
Imprint44;112
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.

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.

💡 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • UNII 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII GYP6Z2JR6Q
    FD&C Yellow No. 6 Aluminum Lake is a yellow colorant made by combining FD&C Yellow No. 6 dye with aluminum salts. It's used to color tablets, capsules, and other medicines so they're easier to identify.
  • 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 VH2XOU12IE
    Polydextrose is a synthetic polymer made from dextrose (sugar) that acts as a bulking agent and filler in medicines. It helps give tablets and capsules proper volume and texture while often adding slight sweetness.
  • 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.
  • 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.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.

12 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statescroscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

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.

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 Consortium
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code68016
First marketedAug 1981
Product typeHuman Otc Drug
Portfolio33 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 📦 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 23 words ▾

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 57 words ▾

Directions adults and children 12 years and over take 2 tablets every 4 to 6 hours; do not take more than 8 tablets in 24 hours children ages 6 to 11 years take 1 tablet every 4 to 6 hours; do not take more than 4 tablets in 24 hours children under 6 years do not use

⚠️ Warnings 145 words ▾

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 diabetes heart disease high blood pressure thyroid disease 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 42 words ▾

Other information each tablet contains: calcium 15 mg 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 9 words ▾

Active ingredient (in each tablet) Pseudoephedrine HCl 30 mg

🧪 Inactive Ingredients 31 words ▾

Inactive ingredients croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, silicon dioxide, titanium dioxide, triacetin

🎯 Purpose 3 words ▾

Purpose Nasal decongestant

📄 Do Not Use 55 words ▾

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 26 words ▾

Ask a doctor before use if you have diabetes heart disease high blood pressure thyroid disease difficulty in urination due to enlargement of the prostate gland

📄 When Using This Product 9 words ▾

When using this product do not exceed recommended dosage.

📄 Stop Use and Ask a Doctor If 23 words ▾

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 10 words ▾

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

📄 Keep Out of Reach of Children 21 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

📄 Questions or Comments 4 words ▾

Questions or comments? 1-800-426-9391

📄 Package Label / Principal Display Panel 132 words ▾

Principal Display Panel Premier Value ® *COMPARE TO THE ACTIVE INGREDIENT IN SUDAFED ® SINUS CONGESTION Maximum Strength Nasal Decongestant Pseudoephedrine HCl 30 mg Nasal Decongestant Non-Drowsy • Nasal & Sinus Congestion • Sinus Pressure 96 Tablets actual size PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED 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 ® Sinus Congestion.

50844 REV0619A11246 Distributed By: Pharmacy Value Alliance, LLC 407 East Lancaster Avenue, Wayne, PA 19087 PV INDEPENDENTLY TESTED SATISFACTION GUARANTEED If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund. 44-112 44-112

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 Nasal Decongestant Maximum Strength (this brand).

Top reported reactions

Pain150
Abdominal Discomfort118
Alopecia118
Pemphigus115
Rheumatoid Arthritis115
Systemic Lupus Erythematosus115
Fatigue84

Age at onset

Adult21
Elderly1

Reporter sex

951 reports
Male · 41%
Female · 57%
Unknown · 2%

Serious outcomes

Hospitalization227
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 36 1
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

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 Consortium has reported a marketing end date of 2027-08-31, 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 24 tablets (68016-0473-96). 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 Consortium 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.
← 68016-0471-01 · Chain 68016-0474-00 · PHARMACY →
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.