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Severe Sinus Congestion Allergy and Cough Formula Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride 325 mg; 10 mg; 6.25 mg; 5 mg Capsule, Liquid Filled — NDC 51013-0169-08 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Severe Sinus Congestion Allergy and Cough Formula Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride 325 mg; 10 mg; 6.25 mg; 5 mg Capsule, Liquid Filled — NDC 51013-169-08 (Billing 51013-0169-08)

by PuraCap Pharmaceutical LLC · 2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Severe Sinus Congestion Allergy and Cough Formula Acetaminophen, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride 325 mg; 10 mg; 6.25 mg; 5 mg Capsule, Liquid Filled from PuraCap Pharmaceutical LLC, marketed since Jun 2016 and currently FDA-listed. It is this product's only package size.

NDC 51013-0169-08
🏷️ FDA NDC (as labeled) 51013-169-08 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 Oct 1, 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) 51013-169-08
Product NDC 51013-169
11-digit billing NDC 51013016908
RxCUI 1297288
UNII 362O9ITL9D, 9D2RTI9KYH, V9BI9B5YI2, 04JA59TNSJ
Application # M012
SPL Set ID 36a4ec1f-50c3-4d61-ada9-987ccad3563c
Established class (EPC) Antihistamine; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Receptor Antagonists [MoA
Mechanism of action Adrenergic alpha1-Agonists; Histamine Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-06-29
Route ORAL
Dosage form CAPSULE, LIQUID FILLED
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1297288
Why two NDCs? The FDA registers this code as 51013-169-08 — 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 → 51013-0169-08. 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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter liquid-filled capsule taken by mouth. It contains acetaminophen, which is typically used to reduce pain and fever, combined with dextromethorphan, which is commonly used to suppress cough. The formula also includes phenylephrine, typically used as a nasal decongestant to relieve sinus congestion, and doxylamine, which functions as a first-generation antihistamine often used for allergy symptoms. This product is marketed under FDA's over-the-counter monograph rules for multi-symptom cold and allergy relief formulas.

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 mLPer 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
51013-0169-08 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2016-06-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka Seltzer Plus Maximum Strength Sinus, Allergy And Cough Power Max Gels 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 00280-0097-01 Bayer 8 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Night Cold and Flu 10 mg/1; 325 mg/1; 6.25 mg/1; 5 mg 00280-1600-20 Bayer 10 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Severe Sinus, Allergy and Cough 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00280-1620-20 Bayer 10 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Night Cold and Flu PowerMax Gels 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 00280-1640-16 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast Gels 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 00280-8276-16 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold Flu and Congestion Severe Night Fast Gels 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 00280-8282-24 Bayer 8 capsules — — FDA listed —
NIGHTTIME COLD AND FLU Maximum Strength 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00363-1011-24 WALGREENS 12 capsules — — FDA listed —
Severe Nighttime Cold And Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 00363-8997-24 WALGREENS 12 capsules — — FDA listed —
Cold And Flu Nighttime Severe 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 11673-0983-08 TARGET 8 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 35916-0167-01 SOFTGEL 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride 325 mg/1; 10 mg/1; 5 mg/1; 6.25 mg 35916-0186-01 Softgel 3000 capsules — — FDA listed —
Vicks NyQuil Severe Cold and Flu 10 mg/1; 6.25 mg/1; 5 mg/1; 325 mg 37000-0518-02 The 2 capsules — — FDA listed —
Severe Sinus Congestion Allergy and Cough Formula 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mgthis 51013-0169-08 PuraCap 10 capsules — — FDA listed —
Night Time Severe Cold and Flu Relief 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 51013-0175-04 PuraCap 12 capsules — — FDA listed —
Nighttime Severe Cold And Flu 5 mg/1; 325 mg/1; 10 mg/1; 6.25 mg 51316-0526-24 CVS 24 capsules — — FDA listed —
Night Cold Flu Cough and Allergy 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 53345-0020-01 Humanwell 4000 capsules — — FDA listed —
ASP Nighttime Max 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 53345-0053-01 Humanwell 4000 capsules — — FDA listed —
Maximum Strenth Night Cold And Flu Formula 10 mg/1; 5 mg/1; 6.25 mg/1; 325 mg 55319-0934-08 FAMILY 8 capsules — — FDA listed —
Maximum Strength Nighttime Severe Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 68210-4210-01 Prodose, 10 capsules — — FDA listed —
RIGHT REMEDIES NIGHTTIME SEVERE COLD AND FLU softgel 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 70692-0837-84 Strive 48 capsules — — FDA listed —
Night Time Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 72476-0998-14 Retail 8 capsules — — FDA listed —
NiteTime SEVERE Cold and Flu Relief SOFTGELS 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 76162-0637-24 Topco 12 capsules — — FDA listed —
TopCare Nite Time SEVERE Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 76162-0812-24 Topco 12 capsules — — FDA listed —
Nighttime Severe Cold And Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 79903-0134-24 Wal-Mart 12 capsules — — FDA listed —
equate MAXIMUM STRENGTH NIGHTTIME SEVERE Cold and Flu SOFTGELS 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 79903-0387-24 WALMART 12 capsules — — FDA listed —
QUALITY CHOICE NightTime Severe Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 83324-0038-24 Chain 12 capsules — — FDA listed —
QUALITY CHOICE Maximum Strength Nighttime Cold and Flu 325 mg/1; 10 mg/1; 6.25 mg/1; 5 mg 83324-0224-24 Chain 12 capsules — — 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

🏛️
2016
On the market since
Jun 2016
📍
2026
Currently FDA-listed
10 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 green
ShapeCapsule
ImprintPC22
Size2 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII PDC6A3C0OX
    Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
  • 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 FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

The official label also statesD&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol,  povidone, propylene glycol, purified water, sorbitol special, and white edible ink

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

LabelerPuraCap Pharmaceutical LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51013
First marketedJun 2016
Product typeHuman Otc Drug
Portfolio21 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 📄 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 49 words ▾

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose sneezing itching of the nose or throat itchy, watery eyes temporarily relieves these symptoms due to a cold: nasal congestion sinus congestion and pressure headache minor aches and pains cough temporarily reduces fever

⏱️ Dosage and Administration 45 words ▾

Directions do not take more than the recommended dose adults and children 12 years and over: take 2 softgelss with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor. children under 12 years: do not use

⚠️ Warnings ~2 min read ▾

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 10 softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 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 to sedate children. 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 taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children Stop use and ask a doctor if pain, cough, 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 cough comes back or occurs with rash or headache that lasts.

These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs 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.

Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📦 Storage and Handling 9 words ▾

Other information Store at room temperature. Avoid excessive heat.

🧪 Active Ingredient 20 words ▾

Active ingredient (in each softgel) Acetaminophen 325 mg Dextromethorphan hydrobromide 10 mg Doxylamine succinate 6.25 mg Phenylephrine hydrochloride 5 mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients D&C yellow #10, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, and white edible ink

🎯 Purpose 9 words ▾

Purposes Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

📄 Do Not Use 102 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 taking this product. if you have ever had an allergic reaction to this product or any of its ingredients in children under 12 years of age

📄 Ask a Doctor Before Use If 55 words ▾

Ask a doctor before use if you have liver disease heart disease high blood pressure thyroid disease diabetes glaucoma cough with excessive phlegm (mucus) a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland persistent or chronic cough such as occurs with smoking, asthma, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 20 words ▾

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin taking sedatives or tranquilizers

📄 When Using This Product 39 words ▾

When using this product do not exceed recommended dosage may cause marked drowsiness avoid alcoholic drinks alcohol, sedatives, and tranquilizers may increase drowsiness be careful when driving a motor vehicle or operating machinery excitability may occur, especially in children

📄 Stop Use and Ask a Doctor If 61 words ▾

Stop use and ask a doctor if pain, cough, 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 cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition. nervousness, dizziness, or sleeplessness occurs

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 43 words ▾

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

📄 Questions or Comments 5 words ▾

Questions or comments? Call: 1-888-309-9030

📄 Package Label / Principal Display Panel 34 words ▾

Principal Display Panel - Carton Label DG Severe Sinus Congestion Allergy & Cough Formula 20 Softgels *Compare to the active ingredients in Alka-Seltzer PLUS® Severe Sinus Congestion, Allergy & Cough NDC 51013-169-08 Carton Label

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, Dextromethorphan hydrobromide , Doxylamine succinate, Phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Choking13
Foreign Body In Throat8
Dizziness4
Vomiting4
Dyspnoea3
Oropharyngeal Pain3
Product Use Complaint3

Reporter sex

34 reports
Male · 12%
Female · 88%

Serious outcomes

Hospitalization4
Life-threatening4
Disabling1
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 4 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: this package is listed as actively marketed, with no marketing end date reported by PuraCap Pharmaceutical LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PuraCap Pharmaceutical LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 51013-0168-08 · PuraCap 51013-0174-04 · PuraCap →
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.