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WALGREENS Cold Cough and Flu Relief acetaminophen, dextromethorphan hydrobromide 650 mg/30mL; 20 mg/30mL Liquid, 355 mL

by WALGREENS CO. · 355 mL in 1 BOTTLE (0363-8100-12)
NDC 00363-8100-12
🏷️ FDA NDC (as labeled) 0363-8100-12 billing pads the labeler segment with a zero
OTC On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 0363-8100-12
Product NDC 0363-8100
11-digit billing NDC 00363810012
RxCUI 2604561
UNII 362O9ITL9D, 9D2RTI9KYH
UPC 0311917065106
Application # M012
SPL Set ID 1e903034-942e-4c6e-9f96-eb097c266580
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist
Mechanism of action Sigma-1 Receptor Agonists; Uncompetitive NMDA Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route ORAL
Dosage form LIQUID
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Why two NDCs? The FDA registers this code as 0363-8100-12 — a 4-4-2 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 labeler segment → 00363-8100-12. 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.

🏭 Manufacturer & labeler

LabelerWALGREENS CO.
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code00363
First marketedApr 2025
Product typeHuman Otc Drug
Portfolio73 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 oral liquid cold and cough product that contains two active ingredients commonly used to manage cold and flu symptoms. Acetaminophen functions as a pain reliever and fever reducer, while dextromethorphan hydrobromide is typically used as a cough suppressant. The product is marketed as an over-the-counter monograph drug, meaning it follows FDA's established rules for this category of cold and cough relief products.

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
1
Nutrient depletion considerations

Acetaminophen, Dextromethorphan may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Acetaminophen, Dextromethorphan nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Daytime 325 mg/15mL; 10 mg/15mL 00113-5305-40 L. 354 ml — — FDA listed —
Walgreens High Blood Pressure Cold and Flu 650 mg/30mL; 20 mg/30mL 00363-6190-08 WALGREENS 236 ml — — FDA listed —
WALGREENS Cold Cough and Flu Relief 650 mg/30mL; 20 mg/30mLthis 00363-8100-12 WALGREENS 355 ml — — FDA listed —
Cold Flu 325 mg/15mL; 10 mg/15mL 42507-0532-40 HyVee 355 ml — — FDA listed —
Daytime Cold and Flu 325 mg/15mL; 10 mg/15mL 51316-0421-12 CVS 355 ml — — FDA listed —
Daytime Cold and Flu Relief 325 mg/15mL; 10 mg/15mL 55319-0954-12 Family 355 ml — — FDA listed —
Sanatos Multi Symptom Daytime 20 mg/30mL; 650 mg/30mL 55758-0415-06 Pharmadel 177 ml — — FDA listed —
Dg Health Cold Flu Relief 325 mg/15mL; 10 mg/15mL 55910-0142-40 Dolgencorp 355 ml — — FDA listed —
Day time high blood pressure cold and flu 650 mg/30mL; 20 mg/30mL 69230-0331-08 Camber 237 ml — — FDA listed —
Vicks DayQuil FOR PEOPLE WITH DIABETES COLD and FLU 650 mg/30mL; 20 mg/30mL 69423-0843-12 The 354 ml — — FDA listed —
Vicks DayQuil HIGH BLOOD PRESSURE Cold and Flu 650 mg/30mL; 20 mg/30mL 69423-0972-06 The 177 ml — — Discontinued —
Topcare DayTime Cold and Flu Relief 325 mg/15mL; 10 mg/15mL 76162-0483-40 Topco 355 ml — — FDA listed —
AXIM DayTime - Liquid 650 mg/30mL; 20 mg/30mL 82706-0011-01 VIVUNT 355 ml — — FDA listed —
AXIV DayTime - Liquid 650 mg/30mL; 20 mg/30mL 82706-0022-01 VIVUNT 355 ml — — FDA listed —
Vicks DayQuil Kids COLD and COUGH plus FEVER 325 mg/15mL; 10 mg/15mL 84126-0304-08 The 236 ml — — FDA listed —
Vicks DayQuil ELDERBERRY COLD and FLU 325 mg/15mL; 10 mg/15mL 84126-0307-12 The 354 ml — — 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

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year 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
00363-8100-12 You're viewing this 355 mL in 1 BOTTLE (0363-8100-12) 2025-04-01 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 — 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 FDA registers it as 0363-8100-12, 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: 00363-8100-12, written without dashes as 00363810012. 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 00363-8100-12, the first segment (00363) is the labeler code FDA assigned to WALGREENS CO.; the middle segment (8100) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) 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 WALGREENS CO.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
WALGREENS CO. 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 22 words ▾

Uses temporarily relieves these symptoms due to a cold or flu: minor aches and pains headache cough sore throat temporarily reduces fever

⏱️ Dosage and Administration 53 words ▾

Directions do not take more than recommended dose adults and children 12 years and over : take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or as directed by a doctor. children under 12 years of age : do not use

⚠️ Warnings ~2 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 or severe allergic reactions. Symptoms may include: skin reddening blisters rash hives facial swelling asthma (wheezing) shock If a skin or general allergic reaction occurs, stop use and seek medical help right away.

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. 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 persistent or chronic cough such as occurs with smoking, asthma or emphysema cough that is accompanied with excessive phlegm (mucus) a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin Stop use and ask a doctor if 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. 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.

🧪 Active Ingredient 13 words ▾

Active Ingredients (in each 30 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg

🧪 Inactive Ingredients 30 words ▾

Inactive ingredient s anhydrous citric acid, Edetate Disodium, FD&C blue #1, FD&C red # 40, flavor, glycerin, Poloxamer, propylene glycol, purified water, Sodium benzoate, potassium Citrate, sorbitol liquid, xanthan gum

🎯 Purpose 6 words ▾

Purpose Pain reliever/fever reducer Cough Suppressant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 00363-8079-36 · Walgreen 00363-8129-05 · Walgreens →
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.