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Daytime Cold and Flu Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg 325 mg; 10 mg; 5 mg Capsule, 24-count — NDC 85828-417-93 (Billing 85828-0417-93)

by Grocery Outlet · 2 BLISTER PACK in 1 CARTON / 12 CAPSULE in 1 BLISTER PACK

This is a package of 24 capsules of Daytime Cold and Flu Acetaminophen 325mg/ Dextromethorphan HBr 10mg/ Phenylephrine HCl 5mg 325 mg; 10 mg; 5 mg Capsule from Grocery Outlet, marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 85828-0417-93
🏷️ FDA NDC (as labeled) 85828-417-93 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

NDC database record

One package, one record: these facts belong to NDC 85828-417-93 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85828 labeler · 417 product · 93 package
Package marketed since
Mar 25, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8582841793 4
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85828-417-93
Product NDC 85828-417
11-digit billing NDC 85828041793
RxCUI 1086997
UNII 362O9ITL9D, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 2f90dfb6-4257-44a8-a685-1873645d1c96
Established class (EPC) Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; 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 2026-03-25
Route ORAL
Dosage form CAPSULE
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1086997
Why two NDCs? The FDA registers this code as 85828-417-93 — 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 → 85828-0417-93. 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 oral capsule containing three active ingredients commonly combined in daytime cold and flu products. Acetaminophen is typically used to reduce fever and relieve aches and pains. Dextromethorphan is a cough suppressant commonly found in cough and cold medicines. Phenylephrine is a decongestant typically used to help relieve nasal congestion. This product is marketed under FDA's over-the-counter monograph rules for cold and flu symptom relief.

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
85828-0417-93 You're viewing this Main listing 2 BLISTER PACK in 1 CARTON / 12 CAPSULE in 1 BLISTER PACK 2026-03-25 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 00904-6995-44 Major 1 capsule $0.131 — Availability likely —
good neighbor pharmacy day time cold and flu 325 mg/1; 10 mg/1; 5 mg 24385-0036-62 Amerisource 2 capsules $0.131 — Availability likely —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 70000-0515-01 CARDINAL 1 capsule $0.131 — Availability likely —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 70000-0752-01 CARDINAL 1 capsule $0.131 — Availability likely —
good sense daytime 325 mg/1; 10 mg/1; 5 mg 00113-0994-51 L. 2 capsules $0.138 — Discontinued —
Alka-Seltzer Plus Maximum Strength Sinus, Congestion and Pain Power Max Gels 325 mg/1; 10 mg/1; 5 mg 00280-0095-01 Bayer 8 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00280-1590-20 Bayer 10 capsules — — FDA listed —
Alka-Seltzer Plus Maximum Strength Day Cold and Flu PowerMax Gels 10 mg/1; 5 mg/1; 325 mg 00280-1630-16 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold Cough Maximum Strength Fast Gels 10 mg/1; 5 mg/1; 325 mg 00280-8275-24 Bayer 8 capsules — — FDA listed —
ALKA SELTZER COLD Cold and Sinus Maximum Strength Fast Gels 325 mg/1; 10 mg/1; 5 mg 00280-8281-24 Bayer 8 capsules — — FDA listed —
Daytime Cold and Flu 5 mg/1; 10 mg/1; 325 mg 00363-0853-16 WALGREENS 8 capsules — — FDA listed —
Daytime Non-Drowsy Cold and Flu 325 mg/1; 10 mg/1; 5 mg 00363-8998-16 Walgreens 8 capsules — — FDA listed —
Maximum Strength Congestion and Headache 325 mg/1; 10 mg/1; 5 mg 00363-9019-16 Walgreens 8 capsules — — FDA listed —
Daytime Ultra Concentrated Cold and Flu 5 mg/1; 325 mg/1; 10 mg 11673-0843-48 TARGET 48 capsules — — FDA listed —
Daytime Cold And Flu Multi Symptom 10 mg/1; 325 mg/1; 5 mg 11673-0975-24 TARGET 12 capsules — — FDA listed —
Multi-Symptom Cold And Flu Relief Daytime 5 mg/1; 325 mg/1; 10 mg 11822-1989-00 RITE 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 11822-3391-08 Rite 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0598-24 Safeway, 1 capsule — — FDA listed —
Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 21130-0650-24 Safeway, 1 capsule — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 21130-0900-24 BETTER 12 capsules — — FDA listed —
Kroger Daytime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 30142-0087-48 The 12 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 35916-0155-01 SOFTGEL 12 capsules — — FDA listed —
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg 5 mg/1; 10 mg/1; 325 mg 35916-0188-01 Softgel 1000 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 35916-0917-01 SOFTGEL 3000 capsules — — FDA listed —
Daytime 5 mg/1; 325 mg/1; 10 mg 37808-0093-16 H-E-B 8 capsules — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0848-16 H 1 capsule — — FDA listed —
Cold and Flu Relief Daytime 325 mg/1; 10 mg/1; 5 mg 37808-0864-16 H 1 capsule — — FDA listed —
day time 325 mg/1; 10 mg/1; 5 mg 37808-0994-60 H 2 capsules — — Discontinued —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 37835-0520-24 Bi-Mart 24 capsules — — FDA listed —
Daytime Cold and Flu Relief Multi-Symptom 325 mg/1; 10 mg/1; 5 mg 41163-0848-24 United 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 41163-0998-24 United 1 capsule — — FDA listed —
Daytime Cold And Flu 10 mg/1; 5 mg/1; 325 mg 41226-0693-24 Kroger 12 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 41520-0068-24 Care 1 capsule — — Discontinued —
cold and flu 325 mg/1; 10 mg/1; 5 mg 42507-0700-62 HyVee 2 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 49035-0193-24 EQUATE 1 capsule — — FDA listed —
Daytime cold and flu 5 mg/1; 325 mg/1; 10 mg 49483-0693-48 TIME 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 51316-0896-24 CVS 1 capsule — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0004-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 53345-0025-01 Humanwell 4000 capsules — — FDA listed —
ASP Daytime PE 325 mg/1; 10 mg/1; 5 mg 53345-0052-01 Humanwell 4000 capsules — — FDA listed —
DayTime Cold/Flu Relief 325 mg/1; 10 mg/1; 5 mg 55301-0604-03 ARMY 12 capsules — — FDA listed —
Maximum Strenght Day Cold And Flu Formula 325 mg/1; 10 mg/1; 5 mg 55319-0933-22 FAMILY 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55319-0967-08 Family 1 capsule — — FDA listed —
Sanatos Daytime 325 mg/1; 10 mg/1; 5 mg 55758-0508-08 Pharmadel 8 capsules — — FDA listed —
Sanatos Daytime Relief 325 mg/1; 10 mg/1; 5 mg 55758-0514-08 Pharmadel 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 55910-0982-08 Dolgencorp, 1 capsule — — FDA listed —
dg health cold plus flu relief 325 mg/1; 10 mg/1; 5 mg 55910-0994-51 Dolgencorp, 2 capsules — — Discontinued —
daytime 325 mg/1; 10 mg/1; 5 mg 56062-0417-62 Publix 2 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 57243-0604-03 SALADO 12 capsules — — FDA listed —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 58602-0768-15 Aurohealth 16 capsules — — FDA listed —
Kroger DayTime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 59450-0046-48 The 12 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0850-24 P 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 59726-0898-08 P 1 capsule — — Discontinued —
Mucinex Sinus-Max Severe Congestion and Pain 325 mg/1; 10 mg/1; 5 mg 63824-0692-16 Reckitt 8 capsules — — FDA listed —
Cold and Flu Daytime 325 mg/1; 10 mg/1; 5 mg 63868-0736-24 QUALITY 1 capsule — — FDA listed —
Circle K Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-5571-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 66715-6815-08 Lil' 2 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 67091-0394-24 WinCo 1 capsule — — FDA listed —
Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 68016-0797-16 Chain 1 capsule — — FDA listed —
Daytime Cold And Flu Multi-Symptom Relief 325 mg/1; 10 mg/1; 5 mg 68016-0877-16 Chain 16 capsules — — FDA listed —
Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride 5 mg/1; 325 mg/1; 10 mg 68210-5053-01 Prodose, 3000 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 69168-0417-29 Allegiant 8 capsules — — FDA listed —
DayTime Cold Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69256-0898-24 Harris 1 capsule — — FDA listed —
Vicks DayQuil ULTRA CONCENTRATED COLD and FLU 5 mg/1; 325 mg/1; 10 mg 69423-0800-48 The 48 capsules — — FDA listed —
Vicks DayQuil COLD and FLU 325 mg/1; 10 mg/1; 5 mg 69423-0994-02 The 2 capsules — — FDA listed —
Day-Time Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 69517-0160-10 HealthLife 10 capsules — — FDA listed —
Activcin 10 mg/1; 325 mg/1; 5 mg 69729-0008-10 OPMX 10 capsules — — FDA listed —
Coldtac Plus Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0120-10 OPMX 10 capsules — — FDA listed —
Desresfriol-DX Softgels 10 mg/1; 325 mg/1; 5 mg 69729-0121-10 OPMX 10 capsules — — FDA listed —
tabcin ACTIVE 10 mg/1; 325 mg/1; 5 mg 69729-0152-10 OPMX 10 capsules — — FDA listed —
Agrifen 325 mg/1; 5 mg/1; 10 mg 69729-0802-10 OPMX 10 capsules — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0848-16 CVS 1 capsule — — FDA listed —
Daytime Cold and Flu Non Drowsy 325 mg/1; 10 mg/1; 5 mg 69842-0897-24 CVS 1 capsule — — FDA listed —
Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) 325 mg/1; 10 mg/1; 5 mg 71679-0101-00 Health 3000 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0005-01 Pioneer 48 capsules — — FDA listed —
Gencare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 72090-0062-01 Pioneer 48 capsules — — FDA listed —
Basic Care Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72288-0994-62 Amazon.com 2 capsules — — FDA listed —
Multi-Symptom Cold and Flu DayTime 325 mg/1; 10 mg/1; 5 mg 72476-0848-24 Care 1 capsule — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 72476-0898-24 Care 1 capsule — — FDA listed —
Mucinex Fast-Max Congestion and Headache Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0128-16 Reckitt 8 capsules — — FDA listed —
Mucinex Sinus-Max Severe Congestion and Pain Maximum Strength 325 mg/1; 10 mg/1; 5 mg 72854-0203-16 Reckitt 8 capsules — — FDA listed —
Daytime Cold and Flu Relief 325 mg/1; 10 mg/1; 5 mg 76162-0065-16 TopCo 16 capsules — — FDA listed —
Daytime Cold and Flu Max Maximum Strength Softgels 325 mg/1; 10 mg/1; 5 mg 76162-0912-24 Topco 12 capsules — — FDA listed —
Daytime Cold and Flu Relief Liquid Filled Softgels 325 mg/1; 10 mg/1; 5 mg 76281-0604-03 AptaPharma 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0807-04 Meijer, 12 capsules — — FDA listed —
meijer Daytime Cold and Flu SOFTGEL 325 mg/1; 10 mg/1; 5 mg 79481-0827-04 Meijer, 12 capsules — — FDA listed —
Daytime Cold And Flu Relief 325 mg/1; 10 mg/1; 5 mg 80513-0303-50 Advanced 50 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 81522-0898-16 FSA 1 capsule — — FDA listed —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0023-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0050-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom mini softgels 325 mg/1; 10 mg/1; 5 mg 83059-0094-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0113-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Multi Symptom Relief 325 mg/1; 10 mg/1; 5 mg 83059-0114-01 Shield 10 capsules — — Discontinued —
Daytime Cold and Flu Mini Softgels 325 mg/1; 10 mg/1; 5 mg 83059-0128-01 Shield 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mg 83324-0145-24 QUALITY 1 capsule — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0018-01 NUVICARE 10 capsules — — FDA listed —
Nuvicare DayTime Cold and Flu Softgel 325 mg/1; 10 mg/1; 5 mg 84324-0023-01 NUVICARE 10 capsules — — FDA listed —
Dr. Simi Daytime Cold and Flu 10 mg/1; 325 mg/1; 5 mg 85786-0601-12 Farmacias 12 capsules — — FDA listed —
Daytime Cold and Flu 325 mg/1; 10 mg/1; 5 mgthis 85828-0417-93 Grocery 24 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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

LabelerGrocery Outlet
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code85828
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio13 products on file

More NDCs from Grocery Outlet labeler code 85828

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 32 words ▾

Use(s) temporarily relieves common cold and flu symptoms: ■ nasal congestion ■ cough due to minor throat and bronchial irritation ■ sore throat ■ headache ■ minor aches and pains ■ fever

⏱️ Dosage and Administration 43 words ▾

Directions take only as directed do not exceed 4 doses per 24 hours Adults and children 12 years and over: 2 softgels with water every 4 hours Children 4 to under 12 years: ask a doctor Children under 4 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 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs containing acetaminophen 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, occurs with or followed by fever, headache, rash, nausea, or vomiting, see 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 drugs.

If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Ask a doctor before use if you have ■ liver disease ■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes ■ trouble urinating due to an enlarged prostate gland ■ persistent or chronic cough such as occurs with smoking, asthma, or emphysema ■ cough that occurs with too much phlegm (mucus) Ask a doctor or pharmacist before use if taking the blood thinning drug warfarin. When using this product do not use more than directed Stop use and ask a doctor before use if you get nervous, dizzy or sleepless symptoms get worse or last more than 5 days (children) or 7 days (adults) fever gets worse or lasts more than 3 days n redness or swelling is present new symptoms occurs cough comes back, or occurs with rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breastfeeding, 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 (1-800-222-1222) right away.

🧪 Active Ingredient 10 words ▾

Active ingredient(s) Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink

🎯 Purpose 8 words ▾

Purpose Pain reliever/fever reducer Cough suppressant Nasal decongestant

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

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — 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 Grocery Outlet. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Grocery Outlet 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.
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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.