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Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate 7.8 mg; 325 mg; 2 mg Tablet, Effervescent — NDC 36800-0768-20 package photo

Effervescent Cold Relief Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate 7.8 mg; 325 mg; 2 mg Tablet, Effervescent

by Topco Associates LLC · 10 POUCH in 1 CARTON (36800-768-20) / 2 TABLET, EFFERVESCENT in 1 POUCH
NDC 36800-0768-20
🏷️ FDA NDC (as labeled) 36800-768-20 billing pads the product segment with a zero
OTC On market Non-controlled
🗂️ Data synced Sep 17, 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

FDA NDC (as labeled) 36800-768-20
Product NDC 36800-768
11-digit billing NDC 36800076820
NCPDP billing unit EA — each (per item)
RxCUI 1536840
UNII 27O3Q5ML57, R16CO5Y76E, V1Q0O9OJ9Z
UPC 0036800067110
Application # M012
SPL Set ID a2929bcb-fa81-4f15-b087-a9996b5e7d1f
Established class (EPC) Nonsteroidal Anti-inflammatory Drug; Platelet Aggregation Inhibitor
Mechanism of action Cyclooxygenase Inhibitors
Physiologic effect Decreased Prostaglandin Production; Decreased Platelet Aggregation
Chemical class Anti-Inflammatory Agents, Non-Steroidal
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2010-07-01
Route ORAL
Dosage form TABLET, EFFERVESCENT
Substance PHENYLEPHRINE BITARTRATE; ASPIRIN; CHLORPHENIRAMINE MALEATE
GPI-14 43994003080830
GPI class Effervescent Cold Relief
Why two NDCs? The FDA registers this code as 36800-768-20 — 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 → 36800-0768-20. 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 Platelet Aggregation Inhibitor class.

Pharmacologic class Platelet Aggregation Inhibitor, Nonsteroidal Anti-inflammatory Drug
Drug family (ATC) Other agents for local oral treatment, Platelet aggregation inhibitors excl. heparin, Salicylic acid and derivatives
How it works Cyclooxygenase Inhibitors
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.

🏭 Manufacturer & labeler

LabelerTopco Associates LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedJul 2010
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.

🩺 Clinical

🧪 What is this product?

This is an over-the-counter effervescent tablet that dissolves in water and is taken by mouth. It contains aspirin, which is typically used to relieve minor aches, pains, and fever; chlorpheniramine maleate, a first-generation antihistamine commonly used to reduce sneezing and runny nose; and phenylephrine bitartrate, a nasal decongestant typically used to relieve nasal congestion. The product is formulated as an OTC monograph drug, meaning it follows FDA's established rules for this class of cold and cough remedies.

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.

🧪 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.

💲 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange Zest 7 mg/1; 2 mg/1; 325 mg 00280-0020-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original PowerFast Fizz 325 mg/1; 2 mg/1; 7.8 mg 00280-0060-01 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Medicine Sparkling Original 325 mg/1; 2 mg/1; 7.8 mg 00280-1400-32 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Orange Zest 325 mg/1; 2 mg/1; 7.8 mg 00280-1510-20 Bayer 2 tablets — — FDA listed —
Alka-Seltzer Plus Cold Sparkling Original 325 mg/1; 7.8 mg/1; 2 mg 00280-1520-04 Bayer 2 tablets — — FDA listed —
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast Dissolve 325 mg/1; 2 mg/1; 7.8 mg 00280-8270-16 Bayer 2 tablets — — FDA listed —
Walgreens Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 00363-0875-36 Walgreens 2 tablets — — FDA listed —
Kroger Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 30142-0875-36 Kroger 2 tablets — — FDA listed —
Effervescent Cold Relief 7.8 mg/1; 325 mg/1; 2 mgthis 36800-0768-20 Topco 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 37808-0768-20 H. 2 tablets — — FDA listed —
Equaline Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41163-0768-20 United 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 41250-0123-20 Meijer 2 tablets — — FDA listed —
Meijer Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 41250-0768-36 Meijer 2 tablets — — FDA listed —
Equate Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 49035-0768-67 Walmart 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 50201-7682-02 Tower 2 tablets — — FDA listed —
Top Value Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mg 50201-8752-00 Tower 2 tablets — — FDA listed —
Good Sense Effervescent Cold Relief 2 mg/1; 325 mg/1; 7.8 mg 50804-0873-20 Good 2 tablets — — FDA listed —
Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 53943-0873-20 Discount 2 tablets — — FDA listed —
Family Wellness Effervescent Cold Relief Orange 2 mg/1; 325 mg/1; 7.8 mg 55319-0875-20 Family 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 55910-0769-20 DOLGENCORP, 2 tablets — — FDA listed —
Dollar General Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 55910-0873-20 DOLGENCORP, 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief Plus 325 mg/1; 2 mg/1; 7.8 mg 63868-0228-20 Chain 2 tablets — — FDA listed —
Quality Choice Effervescent Cold Relief - Orange 7.8 mg/1; 325 mg/1; 2 mg 63868-0568-20 Chain 2 tablets — — FDA listed —
Best Choice Effervescent Cold Relief 325 mg/1; 7.8 mg/1; 2 mg 63941-0873-20 Valu 2 tablets — — FDA listed —
WinCo Foods Effervescent Cold Relief 325 mg/1; 2 mg/1; 7.8 mg 67091-0109-20 WinCo 2 tablets — — FDA listed —
Effervescent Orange Cold Relief 7.8 mg/1; 325 mg/1; 2 mg 69842-0875-20 CVS 2 tablets — — 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

🏛️
2010
On the market since
Jul 2010
📍
2026
Currently FDA-listed
16 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
36800-0768-20 You're viewing this 10 POUCH in 1 CARTON (36800-768-20) / 2 TABLET, EFFERVESCENT in 1 POUCH 2010-07-01 Active

🧭 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) — 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 FDA registers it as 36800-768-20, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 36800-0768-20, written without dashes as 36800076820. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 36800-0768-20, the first segment (36800) is the labeler code FDA assigned to Topco Associates LLC; the middle segment (0768) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
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.

📄 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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 38 words ▾

Uses ■ temporarily relieves these symptoms due to the common cold ■ sneezing ■ nasal congestion ■ sore throat ■ headache ■ minor aches and pains ■ runny nose ■ sinus congestion and pressure ■ temporarily reduces fever

⏱️ Dosage and Administration 51 words ▾

Directions ■ do not use more than directed (see overdose warning) ■ adults and children 12 years and over: take 2 tablets completely dissolved in 4 oz of water every 4 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

⚠️ Warnings 185 words ▾

Warnings Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.

The chance is higher if you ■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

🆘 Overdosage 19 words ▾

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

🧪 Active Ingredient 79 words ▾

Active ingredients Active ingredients (in each effervescent tablet) . . . . . . . . . . .Purpose Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant *Nonsteroidal anti-inflammatory drug

🧪 Inactive Ingredients 16 words ▾

Inactive ingredients acesulfame potassium, aspartame, citric acid, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

🎯 Purpose 77 words ▾

Purpose (in each effervescent tablet) . . . . . . . . . . . Purpose Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant *Nonsteroidal anti-inflammatory drug

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 36800-0766-16 · Topco 36800-0769-04 · 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.