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Fexofenadine Hydrochloride and Pseudoephedrine 60 mg; 120 mg Tablet, Extended Release — NDC 51316-0015-30 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Fexofenadine Hydrochloride and Pseudoephedrine 60 mg; 120 mg Tablet, Extended Release — NDC 51316-015-30 (Billing 51316-0015-30)

by CVS Health Corp · 6 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

This is a package of Fexofenadine Hydrochloride and Pseudoephedrine 60 mg; 120 mg Tablet, Extended Release from CVS Health Corp, marketed since Jun 2022 and currently FDA-listed.

NDC 51316-0015-30
🏷️ FDA NDC (as labeled) 51316-015-30 billing pads the product segment with a zero
This package
Contains5 tablet, extended release in 1 blister pack Pack sizes2 compare ↓
Product page 51316-0015-20 Also comes in: 5 tablets 51316-015-20
OTC Generic 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 51316-015-30 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
51316 labeler · 015 product · 30 package
Package marketed since
Mar 17, 2023
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0050428290538
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51316-015-30
Product NDC 51316-015
11-digit billing NDC 51316001530
RxCUI 997406
UNII 2S068B75ZU, 6V9V2RYJ8N
UPC 0050428290538
Application # ANDA215434
SPL Set ID b009e6b1-57da-a002-1a9e-38a96cc041f1
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 2022-06-03
Route ORAL
Dosage form TABLET, EXTENDED RELEASE
Substance FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 997406
Why two NDCs? The FDA registers this code as 51316-015-30 — 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 → 51316-0015-30. 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 Histamine-1 Receptor Antagonist class.

Pharmacologic class Histamine-1 Receptor Antagonist
Drug family (ATC) Other antihistamines for systemic use
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.

Clinical

📖 What it is MedlinePlus · NLM

The combination of fexofenadine and pseudoephedrine is used to treat allergy or cold symptoms: runny nose sneezing congestion (stuffy nose, sinus pressure) red, itchy, or watery eyes itching of the nose, throat, or roof of the mouth Fexofenadine is in a class of medications called antihistamines. It works by blocking the effects of histamine, a substance in the body that causes allergy symptoms. Pseudoephedrine is in a class of medications called decongestants. It works by causing narrowing of the blood vessels in the nasal passages to relieve congestion.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It actually tackles two things at once. The fexofenadine part is an antihistamine that helps with allergy symptoms like runny nose, sneezing, itchy and watery eyes, and itching of...
  • What exactly does this medication do — does it just help with allergies?
  • Yes, it really does matter. You should take this tablet on an empty stomach with a full glass of water. Also, use water specifically — do not take it with fruit juice. Taking it wi...
  • Does it matter when I take it — like with food or on an empty stomach?
📖 Read our full Fexofenadine and 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: 5 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
51316-0015-20 51316-015-20 Main listing 4 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2023-03-17 — Active
51316-0015-30 You're viewing this 6 BLISTER PACK in 1 CARTON / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK 2023-03-17 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 6 blister pack in 1 carton / 5 tablet, extended release in 1 blister pack.
What NDC number is used to bill for this package of Fexofenadine Hydrochloride and Pseudoephedrine 60 mg; 120 mg Tablet, 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

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 43598-0823-14 Dr. 5 tablets $0.483 — Availability likely —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 46122-0694-65 AmeriSource 10 tablets $0.483 — Availability likely —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 55111-0447-14 Dr. 5 tablets $0.483 — Availability likely —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 00363-0044-20 Walgreens 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 00363-0094-67 WALGREEN 10 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 00363-1606-20 Walgreens 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 00363-2110-20 walgreens 20 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 00536-1431-07 Rugby 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 11822-0021-04 Rite 5 tablets — — FDA listed —
Allergy and Congestion 60 mg/1; 120 mg 11822-7388-05 Rite 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 30142-0059-84 KROGER 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 30142-0097-20 Kroger 5 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 30142-0447-14 The 5 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 30142-0611-14 The 5 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 37808-0022-31 HEB 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 37808-0999-30 H 30 tablets — — FDA listed —
Allegra-D Allergy and Congestion 60 mg/1; 120 mg 41167-4310-02 Chattem, 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 41415-0995-20 PUBLIX 20 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 46122-0452-60 AmeriSource 20 tablets — — Discontinued —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 47335-0724-64 Sun 5 tablets — — FDA listed —
Allegra-D 60 mg/1; 120 mg 50090-1203-00 A-S 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 51316-0007-67 CVS 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mgthis 51316-0015-30 CVS 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 51660-0037-21 Ohm 20 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 58602-0807-67 Aurohealth 10 tablets — — FDA listed —
Fexofenadine HCl and Pseudoephedrine HCI 60 mg/1; 120 mg 59779-0508-14 CVS 5 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 69842-0973-20 CVS 20 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 69842-0990-20 CVS 20 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 70000-0677-01 Cardinal 10 tablets — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 70677-1010-01 Strategic 5 tablets — — FDA listed —
Foster And Thrive Allergy And Congestion D 60 mg/1; 120 mg 70677-1315-01 Strategic 1 tablet — — FDA listed —
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride 60 mg/1; 120 mg 79903-0108-20 Wal-mart 5 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.

Availability & generic status

🏛️
2022
On the market since
Jun 2022
📍
2026
Currently FDA-listed
4 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.

What it looks like

Color White
ShapeCapsule
Size16 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 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 8VAB711C5E
    Hydroxypropyl cellulose is a plant-based thickener made from cellulose. In medicines, it acts as a binder to hold ingredients together, a coating to protect the tablet or capsule, and a thickener to create the right texture in liquids or gels.
  • UNII VM7F0B23ZI
    Hypromellose 2208 is a plant-derived thickening agent that forms a protective coating on tablets and capsules. It slows down how quickly the medicine dissolves, controlling drug release into your body.
  • UNII 0WZ8WG20P6
    Hypromellose 2910 is a plant-based cellulose derivative that acts as a thickener, binder, and film-coating agent. It helps control how quickly the medicine dissolves and protects the tablet or capsule from moisture and light.
  • 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII PNR0YF693Y
    A plant-based powder made from purified wood cellulose. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in the stomach.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • 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 O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

The official label also statescolloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

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

LabelerCVS Health Corp
Application holderDR REDDYS LABORATORIES LTD
FDA applicationANDA215434 (ANDA)
Labeler code51316
First marketedJun 2022
Product typeHuman Otc Drug
Portfolio18 products on file

More NDCs from CVS Health Corp labeler code 51316

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 🧪 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 60 words ▾

Use(s) 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 temporarily relives nasal congestion due to the common cold, hay fever or other upper respiratory allergies reduces swelling of nasal passages temporarily relieves sinus congestion and pressure temporarily restores freer breathing through the nose

⏱️ Dosage and Administration 73 words ▾

Directions do not divide, crush, chew or dissolve the tablet; swallow tablet whole adults and children 12 years of age and over take 1 tablet with a glass of water every 12 hours on an empty stomach; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

⚠️ Warnings ~1 min read ▾

Warnings Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease.

Your doctor should determine if you need a different dose. When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless 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.

🧪 Active Ingredient 12 words ▾

Active ingredient(s) Fexofenadine HCl USP, 60 mg Pseudoephedrine HCl USP, 120 mg

🧪 Inactive Ingredients 47 words ▾

Inactive ingredients colloidal silicon dioxide, croscarmellose sodium, ferric oxide (iron oxide yellow), HPMC 2910 / hypromellose (6 Cps), hydroxypropyl cellulose, hypromellose (methocel K100M DC2), macrogol (polyethylene glycol MW 400), macrogol (polyethylene glycol MW 8000), magnesium stearate, microcrystalline cellulose (avicel PH 101), microcrystalline cellulose (avicel PH102), pregelatinized starch.

🎯 Purpose 4 words ▾

Purpose Antihistamine Nasal decongestant

📄 Do Not Use 76 words ▾

Do not use if you have ever had an allergic reaction to this product or any of its ingredients 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. if you have difficulty swallowing

📄 Ask a Doctor Before Use If 37 words ▾

Ask a doctor before use if you have heart disease thyroid disease glaucoma high blood pressure diabetes trouble urinating due to an enlarged prostate gland kidney disease. Your doctor should determine if you need a different dose.

📄 When Using This Product 49 words ▾

When using this product do not take more than directed do not take at the same time as aluminum or magnesium antacids do not take with fruit juices (see Directions) the tablet coating may be seen in the stool (this is normal). Continue to take as directed (see Directions).

📄 Stop Use and Ask a Doctor If 37 words ▾

Stop use and ask doctor if an allergic reaction to this product occurs. Seek medical help right away. symptoms do not improve within 7 days or are accompanied by a fever you get nervous, dizzy, or sleepless

🤰 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 3 words ▾

Questions? Call 1-888-375-3784

📄 Package Label / Principal Display Panel 5 words ▾

Principal Display Panel Blister carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 CVS Health Corp. 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 1 other package presentation of this same product, including 5 tablets (51316-0015-20). 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?
CVS Health Corp 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.
← 51316-0013-01 · CVS 51316-0016-01 · CVS →
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.