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Topcare Nite Time Day Time Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl Kit — NDC 36800-580-72 (Billing 36800-0580-72)

by Topco Associates LLC · 1 KIT in 1 CARTON * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

This is a package of Topcare Nite Time Day Time Cold and Flu Acetaminophen, dextromethorphan HBr, doxylamine succinate, phenylephrine HCl Kit from Topco Associates LLC, marketed since Apr 2014 and currently FDA-listed. It is this product's only package size.

NDC 36800-0580-72
🏷️ FDA NDC (as labeled) 36800-580-72 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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 36800-580-72
Product NDC 36800-580
11-digit billing NDC 36800058072
RxCUI 1086997, 1094549, 2634564
Application # M012
SPL Set ID efb8e0e2-0795-4f4a-8ca6-955f33bee143
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2014-04-29
Dosage form KIT
Quick answers
  • RxCUI (RxNorm): 1086997
Why two NDCs? The FDA registers this code as 36800-580-72 — 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 → 36800-0580-72. 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?

This is an over-the-counter kit containing two medicine formulations for cold and flu symptoms, sold under FDA's monograph rules for this product category. The daytime formulation contains acetaminophen (a pain reliever and fever reducer) and phenylephrine (a nasal decongestant), while the nighttime formulation adds doxylamine (a sleep aid) and dextromethorphan (a cough suppressant). The kit is designed to address different symptom relief needs during day and night hours.

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
36800-0580-72 You're viewing this Main listing 1 KIT in 1 CARTON * 8 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK * 16 BLISTER PACK in 1 CARTON / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2014-04-29 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
foster and thrive daytime cold and flu relief nighttime cold and flu relief 70677-1028-01 Strategic 2 capsules $0.151 — FDA listed —
Goodnow cold flu day relief cold flu night relief 82501-1211-01 Gobrands, 2 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 41163-0901-48 United 1 capsule — — FDA listed —
NiteTime DayTime Cold and Flu 41250-0597-02 Meijer 1 kit — — FDA listed —
Daytime Nighttime Cold and Flu Relief Multi-Symptom 67091-0336-48 WinCo 16 capsules — — FDA listed —
Cold and Flu Day, Night 00363-1213-02 Walgreen 1 kit — — FDA listed —
daytime nighttime cold and flu 00363-1733-02 Walgreen 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 72476-0850-48 Care 16 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 11822-0851-04 Rite 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 21130-0058-48 Safeway, 16 capsules — — FDA listed —
equaline daytime and nighttime cold and flu relief 41163-0567-02 United 1 kit — — FDA listed —
equate daytime cold and flu nighttime cold and flu 49035-0718-02 Wal-Mart 1 kit — — FDA listed —
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9012-48 Walgreens 8 capsules — — FDA listed —
Vicks DayQuil NyQuil ULTRA CONCENTRATED COLD and FLU 69423-0802-96 The 1 kit — — FDA listed —
Topcare Nite Time Day Time Cold and Fluthis 36800-0580-72 Topco 2 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 68016-0799-48 Chain 1 capsule — — Discontinued —
Cold And Flu Daytime-Nighttime 11673-0984-24 TARGET 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 49035-0192-48 EQUATE 16 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 69256-0901-48 Harris 1 capsule — — FDA listed —
basic care daytime nighttime cold and flu 72288-0733-02 Amazon.com 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 72476-0901-48 Care 32 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 55319-0566-24 Family 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 67091-0393-48 WinCo 1 capsule — — FDA listed —
Severe Cold and Flu 00363-1597-02 Walgreen 1 kit — — FDA listed —
Cold and Flu Daytime, Nighttime, Multi-Symptom 00363-9011-24 Walgreens 8 capsules — — FDA listed —
Daytime Nighttime Cold Flu Relief 69842-0852-24 CVS 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 81522-0901-48 FSA 1 capsule — — FDA listed —
Daytime Nighttime Cold Flu Relief 21130-0901-48 Safeway, 16 capsules — — FDA listed —
TopCare Day Time Nite Time Cold and Flu Relief 36800-0301-02 Topco 1 kit — — FDA listed —
Daytime Nighttime Cold and Flu Relief Multi-Symptom 59726-0901-24 P 8 capsules — — FDA listed —
daytime nighttime cold and flu 00363-0567-02 Walgreen 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 69842-0896-24 CVS 1 capsule — — FDA listed —
basic care daytime cold and flu nighttime cold and flu 72288-0580-72 Amazon.com 2 capsules — — FDA listed —
Cold and Flu Daytime Nighttime 51316-0123-02 CVS 1 kit — — FDA listed —
Topcare Day Time Nite Time Cold and Flu 36800-0597-02 Topco 1 kit — — FDA listed —
Daytime Nighttime Cold Flu Relief 41163-0850-48 United 16 capsules — — FDA listed —
Daytime-Nighttime Severe Cold And Flu 41226-0627-24 KROGER 4 capsules — — FDA listed —
daytime nitetime cold and flu 41250-0733-02 Meijer 1 kit — — FDA listed —
dg health cold and flu relief 55910-0811-72 Dolgencorp 2 capsules — — FDA listed —
Severe Nighttime Severe Daytime 59779-0597-02 CVS 1 kit — — FDA listed —
Severe Cold and Flu Nighttime Daytime 42507-0597-02 HyVee 1 kit — — FDA listed —
Daytime Nighttime Cold And Flu 72288-0791-02 Amazon.com 1 kit — — FDA listed —
Good Sense Daytime Nighttime Cold And Flu 00113-5800-72 L. 2 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

🏛️
2014
On the market since
Apr 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

LabelerTopco Associates LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedApr 2014
Product typeHuman Otc Drug
Portfolio408 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 72 words ▾

Uses – Nitetime Cold & Flu temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • runny nose and sneezing • fever

Uses – Daytime Cold & Flu temporarily relieves common cold/flu symptoms: • cough due to minor throat and bronchial irritation • minor aches and pains • sore throat • headache • nasal congestion • fever

⏱️ Dosage and Administration 108 words ▾

Directions – Nitetime Cold & Flu • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Directions – Daytime Cold & Flu • take only as directed – see overdose warning • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 2 softgels with water every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

⚠️ Warnings ~3 min read ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • 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.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly. 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 Ask a doctor before use if you have – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • diabetes • heart disease • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu taking the blood thinning drug warfarin When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness When using this product – Daytime Cold & Flu do not use more than directed Stop use and ask a doctor if – Nighttime Cold & Flu • pain or cough 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. Stop use and ask a doctor if – Daytime Cold & Flu • you get nervous, dizzy or sleepless • pain, nasal congestion or cough 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.

If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

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 11 words ▾

Other information • store at 20-25 ° C (68-77 ° F)

🧪 Active Ingredient 21 words ▾

Active ingredients (in each softgel) – Nitetime Cold & Flu Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

🧪 Inactive Ingredients 66 words ▾

Inactive ingredients – Nitetime Cold & Flu D&C yellow no. 10, edible ink*, FD&C blue no. 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Inactive ingredients – Daytime Cold & Flu edible ink*, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

🎯 Purpose 25 words ▾

Purpose – Nitetime Cold & Flu Pain reliever/fever reducer Cough suppressant Antihistamine

Purpose – Daytime Cold & Flu Pain reliever/fever reducer Cough suppressant Nasal decongestant

📄 Do Not Use 98 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

📄 Ask a Doctor Before Use If 116 words ▾

Ask a doctor before use if you have – Nighttime Cold & Flu • liver disease • glaucoma • cough that occurs with too much phlegm (mucus) • a breathing problem such as emphysema or chronic bronchitis • persistent or chronic cough as occurs with smoking, asthma, or emphysema • trouble urinating due to an enlarged prostate gland

Ask a doctor before use if you have – Daytime Cold & Flu • liver disease • diabetes • heart disease • high blood pressure • thyroid disease • trouble urinating due to an enlarged prostate gland • cough that occurs with too much phlegm (mucus) • persistent or chronic cough as occurs with smoking, asthma, or emphysema

📄 Ask a Doctor or Pharmacist Before Use If 48 words ▾

Ask a doctor or pharmacist before use if you are – Nighttime Cold & Flu • taking sedatives or tranquilizers • taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are – Daytime Cold & Flu taking the blood thinning drug warfarin

📄 When Using This Product 54 words ▾

When using this product • excitability may occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • be careful when driving a motor vehicle or operating machinery • alcohol, sedatives, and tranquilizers may increase drowsiness

When using this product – Daytime Cold & Flu do not use more than directed

📄 Stop Use and Ask a Doctor If 137 words ▾

Stop use and ask a doctor if – Nighttime Cold & Flu • pain or cough 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.

Stop use and ask a doctor if – Daytime Cold & Flu • you get nervous, dizzy or sleepless • pain, nasal congestion or cough 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.

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 46 words ▾

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). 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 4 words ▾

Questions or comments? 1-888-423-0139

📄 Package Label / Principal Display Panel 148 words ▾

Principal Display Panel - Daytime SPECIAL VALUE! COMBINATION PACK Top Care ® health COMPARE TO VICKS ® DAYQUIL ® COLD & FLU ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF Day Time Cold & Flu Relief PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr NASAL DECONGESTANT - PHENYLEPHRINE HCl • Headache, Fever, Sore Throat, Minor Aches & Pains • Nasal Congestion • Cough Alcohol Free Antihistamine Free Non-Drowsy actual size 32 SOFTGELS Top Care ® health COMPARE TO VICKS ® NYQUIL ® COLD & FLU ACTIVE INGREDIENTS MULTI-SYMPTOM RELIEF Nite Time Cold & Flu Relief PAIN RELIEVER – FEVER REDUCER - ACETAMINOPHEN COUGH SUPPRESSANT - DEXTROMETHORPHAN HBr ANTIHISTAMINE - DOXYLAMINE SUCCINATE • Headache, Fever, Sore Throat, Minor Aches & Pains • Sneezing, Runny Nose • Cough Alcohol Free actual size 16 SOFTGELS Daytime Nighttime Cold and Flu Relief Image 1 Daytime Nighttime Cold and Flu Relief Image 2

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 Kit / multi-component package

Kit / multi-component package

This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.

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: this package is listed as actively marketed, with no marketing end date reported by Topco Associates LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates 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.
← 36800-0575-02 · TopCo 36800-0581-62 · Topco →
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.