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Dologesic NF Acetaminophen, Dexbrompheniramine Maleate 500 mg; 1 mg Tablet, 100-count — NDC 54859-0001-01 package photo

Dologesic NF Acetaminophen, Dexbrompheniramine Maleate 500 mg; 1 mg Tablet, 100-count

by Llorens Pharmaceutical International Division · 100 TABLET in 1 BOTTLE (54859-001-01)
NDC 54859-0001-01
🏷️ FDA NDC (as labeled) 54859-001-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.2153 NADAC Per package$21.53 / 100 tablets Pack sizes2 compare ↓
Also comes in: 50 tablets 54859-0001-50
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) 54859-001-01
Product NDC 54859-001
11-digit billing NDC 54859000101
NCPDP billing unit EA — each (per item)
RxCUI 1798453
UNII 362O9ITL9D, BPA9UT29BS
UPC 0354859001016
Application # M012
SPL Set ID 974fc0d5-7a99-46fb-af38-b91240f728fa
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-01
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE
GPI-14 43992002170325
GPI class Dologesic
GCN Seq No 076023
GCN 41262
HICL code 038226
Ingredient (HICL) Acetaminophen/D-Brompheniramin
HIC1 code B
Therapeutic class — broad (HIC1) Respiratory System
HIC2 code B5
Therapeutic class — intermediate (HIC2) Drugs Affecting The Trachea And Bronchi (Contin.2)
HIC3 code B5S
Therapeutic class — specific (HIC3) Analgesic, Non-Sal.- 1St Generation Antihistamine
AHFS code 04:04.20.00
AHFS class Propylamine Derivatives
FDB label name DOLOGESIC 500-1 MG CAPLET
FDB brand name Dologesic
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 54859-001-01 — 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 → 54859-0001-01. 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

LabelerLlorens Pharmaceutical International Division
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code54859
First marketedApr 2016
Product typeHuman Otc Drug
Portfolio10 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

Label name DOLOGESIC 500-1 MG CAPLET Ingredient Acetaminophen/D-Brompheniramin
🧪 What is this product?

Dologesic NF is an over-the-counter tablet taken by mouth that combines acetaminophen and dexbrompheniramine maleate. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Dexbrompheniramine maleate is an antihistamine commonly used to reduce symptoms like sneezing, runny nose, and watery eyes associated with allergies or cold. This combination product is marketed as an OTC monograph drug under FDA regulations for its category.

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.

💊 What it looks like

Color orange
ShapeCapsule
ImprintLLORENS
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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 532B59J990
    Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
  • UNII AG9B65PV6B
    A starch derivative made from corn that helps tablets and capsules break apart quickly when swallowed. It acts as a disintegrant, allowing the medicine to dissolve and be absorbed in your stomach and intestines.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII K4C08XP666
    A mineral salt made from calcium and phosphate. It acts as a filler to add bulk and texture to tablets and powders, and also helps stabilize and bind ingredients together.

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

The official label also statesFD&C Red #40, FD&C Yellow #6, glycerin, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose,polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, tricalcium phosphate

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.

💲 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 eaPer package
Retail pharmacies payNADAC · weekly $0.215 $21.53 / 100 tablets
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.
NADAC price history (per ea) — tap or hover for the price & month
Oct 2025 $0.215 $0.215
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
Dologesic NF 500 mg/1; 1 mgthis 54859-0001-01 Llorens 100 tablets $0.215 — FDA listed —
Dologesic DF 500 mg/1; 1 mg 54859-0010-01 Llorens 100 tablets $0.215 — FDA listed —
Actidogesic 1 mg/1; 500 mg 63102-0402-10 ACTIPHARMA, 100 tablets — — FDA listed —
Actidogesic Df 500 mg/1; 1 mg 63102-0403-10 ACTIPHARMA, 100 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

🏛️
2016
On the market since
Apr 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.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
54859-0001-01 You're viewing this 100 TABLET in 1 BOTTLE (54859-001-01) $0.2153 / ea $21.53 2016-04-01 Active
54859-0001-50 50 TABLET in 1 BOTTLE (54859-001-50) $0.2153 / ea $10.76 2016-04-01 Active

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2153 NADAC).

Pack size FAQ

What quantity is in NDC 54859-0001-01?
NDC 54859-0001-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 54859-0001-01 and NDC 54859-0001-50?
Both are Dologesic NF Acetaminophen, Dexbrompheniramine Maleate 500 mg; 1 mg Tablet — the drug itself is identical. NDC 54859-0001-01 is the 100-count package, while NDC 54859-0001-50 is the 50 tablets package.
What NDC number is used to bill for this package of Dologesic NF Acetaminophen, Dexbrompheniramine Maleate 500 mg; 1 mg Tablet?
Bill NDC 54859-0001-01 — the 11-digit billing format is 54859000101. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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 35 words ▾

Uses For the temporary relief of minor aches and pains associated with headache muscular aches backaches minor arthritis pain common cold toothaches menstrual cramps temporarily reduces fever itchy and watery eyes due to hay fever

⏱️ Dosage and Administration 119 words ▾

Directions Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms Do not exceed recommended dosage Age Dose adults and children 12 years of age and over Take 2 caplets every 4-6 hours.

Do not take more than 8 caplets in 24 hours, or as directed by a doctor children under 12 years of age Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

⚠️ Warnings ~1 min read ▾

Warnings Alcohol Warning : If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take more than 8 capsules in 24 hours, which is the maximum daily amount with other drugs containing acetaminphen 3 or more alcoholic drinks every day while using this product May cause drowsiness:: alcohol, sedatives and tranquilizers may increase the drowsiness effect.

Avoid alcoholic beverages while taking this product Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor. Use caution when driving motor vehicle or operating machinery Do not use with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist if you are allergic to acetaminophen or any of the inactive ingredients in the product for more than 10 days for pain, unless directed by a doctor for more than 3 days for fever, unless directed by a doctor Ask a doctor before use: if you have liver disease if you are taking the blood thinning drug warafin Stop using this product and ask a doctor if: pain gets worse or last more than 10 days fever gets worse or last more than 3 days new symptoms occur redness or swelling is present these could be signs of a serious condition

🧪 Active Ingredient 12 words ▾

Active Ingredients (in each caplet) Acetaminophen 500 mg Dexbrompheniramine Maleate 1 mg

🧪 Inactive Ingredients 27 words ▾

Inactive ingredients FD&C Red #40, FD&C Yellow #6, glycerin, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose,polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, tricalcium phosphate

🎯 Purpose 5 words ▾

Purpose Pain reliever/fever reducer antihistamine

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 54838-0570-59 · Lannett 54859-0010-01 · Llorens →
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.