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Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg; 4 mg; 10 mg Tablet, 144-count — NDC 69729-0322-38 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg; 4 mg; 10 mg Tablet, 144-count — NDC 69729-322-38 (Billing 69729-0322-38)

by OPMX LLC · 144 TABLET in 1 POUCH

This is a package of 144 tablets of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg; 4 mg; 10 mg Tablet from OPMX LLC, marketed since Aug 2019 and currently FDA-listed.

NDC 69729-0322-38
🏷️ FDA NDC (as labeled) 69729-322-38 billing pads the product segment with a zero
This package
Contains144-count Pack sizes3 compare ↓
Product page 69729-0322-27 Also comes in: 2 tablets 69729-322-27 12 tablets 69729-322-37
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 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 69729-322-38 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
69729 labeler · 322 product · 38 package
Package marketed since
Aug 26, 2019
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Barcode (UPC)
0856828008137
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 69729-322-38
Product NDC 69729-322
11-digit billing NDC 69729032238
RxCUI 2463332
UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
UPC 0856828008137
Application # M012
SPL Set ID b3c229a4-c772-70fb-e053-2a95a90a72db
Established class (EPC) Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-08-26
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 2463332
Why two NDCs? The FDA registers this code as 69729-322-38 — 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 → 69729-0322-38. 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

📖 About the active ingredient MedlinePlus · NLM
General information about the ingredient itself — the description of this specific product follows below.

Acetaminophen is used to relieve mild to moderate pain and to reduce fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.

Read the full MedlinePlus article ↗
🧪 What is this product?

This is an over-the-counter tablet taken by mouth that combines three active ingredients commonly used for cold and allergy symptom relief. Acetaminophen is typically used to reduce fever and ease pain and body aches. Chlorpheniramine maleate is an antihistamine commonly used to help relieve sneezing, itching, and watery eyes caused by allergies or colds. Phenylephrine hydrochloride is a decongestant typically used to help relieve nasal congestion.

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.
Try another pack size: 2 tablets 12 tablets
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
69729-0322-27 69729-322-27 Main listing 2 TABLET in 1 POUCH 2019-08-26 — Active
69729-0322-37 69729-322-37 12 TABLET in 1 POUCH 2019-08-26 — Active
69729-0322-38 You're viewing this 144 TABLET in 1 POUCH 2019-08-26 — Active

You're viewing the largest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 144-count package — 144 tablet in 1 pouch.
How does this package differ from NDC 69729-0322-27?
Both are Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg; 4 mg; 10 mg Tablet — the drug itself is identical. This page's package is the 144-count one, while NDC 69729-0322-27 is the 2 tablets package.
What NDC number is used to bill for this package of Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg; 4 mg; 10 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg/1; 4 mg/1; 10 mg 69729-0122-37 OPMX 12 tablets — — FDA listed —
Coldtac Ultra 10 mg/1; 500 mg/1; 4 mg 69729-0133-06 OPMX 6 tablets — — FDA listed —
Pentrexcilina Daytime 10 mg/1; 4 mg/1; 500 mg 69729-0223-06 OPMX 6 tablets — — FDA listed —
Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl 500 mg/1; 4 mg/1; 10 mgthis 69729-0322-38 OPMX 144 tablets — — FDA listed —
Resfriol D 10 mg/1; 500 mg/1; 4 mg 69729-0323-27 OPMX 2 tablets — — FDA listed —
Desenfriol D 500 mg/1; 4 mg/1; 10 mg 69729-0829-30 OPMX 30 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

🏛️
2019
On the market since
Aug 2019
📍
2026
Currently FDA-listed
7 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.

What it looks like

Color white
ShapeRound
ImprintS78
Size13 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 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 U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

The official label also statesmagnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

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.

Manufacturer & labeler

LabelerOPMX LLC
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code69729
First marketedAug 2019
Product typeHuman Otc Drug
Portfolio87 products on file

More NDCs from OPMX LLC labeler code 69729

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 🆘 Overdosage 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Keep Out of Reach of Children 📄 Other Information 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 53 words ▾

Temporarily relieves these symptoms of hay fever or other respiratory allergies: Headache Nasal congestion Sinus congestion & pressure Runny nose and sneezing Minor aches & pain Temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages

⏱️ Dosage and Administration 63 words ▾

Do not take more than directed - see overdose warning swallow whole; do not crush, chew or dissolve do not exceed 6 tablets per 24 hours Adults and children 12 years of age & over 1 tablet with water every 4-6 hours as needed Children 4 to 12 years of age Ask a doctor Children under 4 years of age Do not use

⚠️ Warnings ~1 min read ▾

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take : more than 6 tablets in 24 hours, which is the maximum daily amount for this product with other drugs contains 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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. Ask a doctor before use if you have: Liver disease High blood pressure Thyroid disease Diabetes Trouble urinating due to enlarged prostate gland A breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.

Stop use and ask a doctor if: You get nervous, dizzy, or sleepless Pain, nasal congestion, or cough gets worse or lasts more than 7 days Fever gets worse or last more than 3 days Redness or swelling is present New symptoms occur 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.

🆘 Overdosage 42 words ▾

OVERDOSE WARNING: Read directions carefully. In case of overdose, get medical help or contact a 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.

🧪 Active Ingredient 8 words ▾

Acetaminophen 500mg Chlorpheniramine Maleate 4mg Phenylephrine HCl 10mg

🧪 Inactive Ingredients 12 words ▾

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

🎯 Purpose 6 words ▾

Pain reliever/fever reducer Antihistamine Nasal decongestant

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Other Information 12 words ▾

store at room temperature between 20-25°C (68-77ºF) avoid excessive heat and humidity

📄 Package Label / Principal Display Panel 3 words ▾

38 27 37

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

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl — the ingredient across all brands.

Top reported reactions

Fatigue3,340
Headache3,128
Nausea2,948
Dyspnoea2,940
Diarrhoea2,393
Pain2,364
Dizziness2,203

Age at onset

Neonate2
Infant6
Child201
Adolescent184
Adult3,295
Elderly2,385

Reporter sex

49,726 reports
Male · 32%
Female · 68%
Unknown · 0%

Serious outcomes

Hospitalization11,000
Disabling1,252
Life-threatening927
Reports over time (by year) — tap or hover for the count & year
2021 2022 2024 2026 2,715 1,024
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

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) ✓ 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 OPMX LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 2 tablets (69729-0322-27), 12 tablets (69729-0322-37). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
OPMX 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.
← 69729-0301-51 · OPMX 69729-0323-27 · OPMX →
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.