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Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE 325 mg; 5 mg; 2 mg Tablet, Coated, 250-count — NDC 50332-0153-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE 325 mg; 5 mg; 2 mg Tablet, Coated, 250-count — NDC 50332-0153-7 (Billing 50332-0153-07)

by HART Health · 250 TABLET, COATED in 1 BOX, UNIT-DOSE

This is a package of 250 tablets of Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE 325 mg; 5 mg; 2 mg Tablet, Coated from HART Health, marketed since Apr 2012 and currently FDA-listed.

NDC 50332-0153-07
🏷️ FDA NDC (as labeled) 50332-0153-7 billing pads the package segment with a zero
This package
Contains250-count Pack sizes2 compare ↓
Product page 50332-0153-04 Also comes in: 100 tablets 50332-0153-4
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 27, 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 50332-0153-7 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
50332 labeler · 0153 product · 7 package
Package marketed since
Apr 16, 2012
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 5033201537 2
FDA record last changed
Aug 27, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50332-0153-7
Product NDC 50332-0153
11-digit billing NDC 50332015307
RxCUI 1046781
UNII 362O9ITL9D, 04JA59TNSJ, V1Q0O9OJ9Z
Application # M
SPL Set ID 9475fb51-931b-4a89-be6b-62e715d0883e
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 2012-04-16
Route ORAL
Dosage form TABLET, COATED
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE
Quick answers
  • RxCUI (RxNorm): 1046781
Why two NDCs? The FDA registers this code as 50332-0153-7 — a 5-4-1 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 package segment → 50332-0153-07. 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?

Relief-PE is an over-the-counter coated tablet taken by mouth that combines three active ingredients. Acetaminophen is typically used to reduce fever and relieve minor aches and pain. Phenylephrine is a decongestant commonly used to help shrink swollen nasal passages and ease congestion. Chlorpheniramine is an antihistamine often used to help relieve allergy symptoms such as sneezing, itching, and runny nose. This product is marketed under FDA's OTC monograph rules for its category.

1
Nutrient depletion considerations

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

🧪 Full Acetaminophen, Phenylephrine, Chlorpheniramine 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.

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: 100 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
50332-0153-04 50332-0153-4 Main listing 100 TABLET, COATED in 1 BOX, UNIT-DOSE 2012-04-16 — Active
50332-0153-07 You're viewing this 250 TABLET, COATED in 1 BOX, UNIT-DOSE 2012-04-16 — Active

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

Pack size FAQ

What quantity is in this package?
This is a 250-count package — 250 tablet, coated in 1 box, unit-dose.
How does this package differ from NDC 50332-0153-04?
Both are Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE 325 mg; 5 mg; 2 mg Tablet, Coated — the drug itself is identical. This page's package is the 250-count one, while NDC 50332-0153-04 is the 100 tablets package.
What NDC number is used to bill for this package of Relief-PE ACETAMINOPHEN, PHENYLEPHRINE, CHLORPHENIRAMINE 325 mg; 5 mg; 2 mg Tablet, Coated?
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
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 46122-0660-62 AMERISOURCE 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70000-0211-01 Cardinal 12 tablets $0.086 — Availability likely —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 70677-1004-01 STRATEGIC 12 tablets $0.086 — Availability likely —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 83324-0086-24 CHAIN 12 tablets $0.086 — Availability likely —
FLONASE Headache and Allergy Relief 325 mg/1; 2 mg/1; 5 mg 00135-0578-01 Haleon 12 tablets — — FDA listed —
Multi-Symptom Allergy 325 mg/1; 2 mg/1; 5 mg 00363-0559-08 Walgreen 12 tablets — — FDA listed —
PhysiciansCare Allergy Multi-Symptom Relief 325 mg/1; 2 mg/1; 5 mg 00924-0091-01 Acme 2 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 36800-0628-02 TOPCO 12 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 37808-0628-02 HEB 12 tablets — — FDA listed —
Medique Medicidin D 325 mg/1; 2 mg/1; 5 mg 47682-0120-13 Unifirst 2 tablets — — FDA listed —
Otis Clapp Valihist 325 mg/1; 2 mg/1; 5 mg 47682-0543-03 Unifirst 2 tablets — — FDA listed —
Relief-PE 325 mg/1; 5 mg/1; 2 mgthis 50332-0153-07 HART 250 tablets — — FDA listed —
Allergy Multi Symptom 325 mg/1; 2 mg/1; 5 mg 50804-0128-02 GOODSENSE 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 50844-0455-08 L.N.K. 12 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0005-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0010-01 FORTUNE 24 tablets — — FDA listed —
Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0011-01 FORTUNE 24 tablets — — FDA listed —
Extra Fast Coltalin 325 mg/1; 2 mg/1; 5 mg 51467-0014-01 FORTUNE 24 tablets — — FDA listed —
Defensol D 325 mg/1; 2 mg/1; 5 mg 53145-0005-02 Menper 100 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 53943-0228-02 DISCOUNT 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55301-0455-08 ARMY 12 tablets — — FDA listed —
Allergy Multi-Symptom 325 mg/1; 2 mg/1; 5 mg 55910-0455-08 DOLGENCORP, 12 tablets — — FDA listed —
Allergy Multi Symptom 5 mg/1; 325 mg/1; 2 mg 57344-0928-02 AAA 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 63654-0275-20 Selder, 20 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mg 63654-0605-20 Selder, 20 tablets — — FDA listed —
Allergy Multisymptom 325 mg/1; 2 mg/1; 5 mg 63868-0578-24 CHAIN 12 tablets — — FDA listed —
Allergy Sinus, Lil Drug Store 325 mg/1; 5 mg/1; 2 mg 66715-9927-03 Lil' 6 tablets — — FDA listed —
Allergy Multi Symptom 2 mg/1; 5 mg/1; 325 mg 68998-0228-02 MARC 12 tablets — — FDA listed —
Cold Medicine 325 mg/1; 2 mg/1; 5 mg 69168-0004-51 Allegiant 20 tablets — — FDA listed —
Allergy MultiSymptom 325 mg/1; 2 mg/1; 5 mg 72476-0128-02 RETAIL 12 tablets — — FDA listed —
Cold Medicine XL3 325 mg/1; 2 mg/1; 5 mg 76095-0011-20 Midway 20 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

🏛️
2012
On the market since
Apr 2012
📍
2026
Currently FDA-listed
14 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.

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

LabelerHART Health
FDA applicationM (OTC MONOGRAPH DRUG)
Labeler code50332
First marketedApr 2012
Product typeHuman Otc Drug
Portfolio36 products on file

More NDCs from HART Health labeler code 50332

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 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 31 words ▾

Temporarily relieves nasal congestion, sinus pressure, and minor aches and pains due to: the common cold hay fever upper respiratory allergies headache itchy/watery eyes runny nose muscular aches Temporarily reduces fever

⏱️ Dosage and Administration 52 words ▾

Directions: Do not take more than directed . Adults and children 12 years of age an over: take 1 to 2 tablets every 6 hours while symptoms persist do not take more than 8 tablets in 24 hours unless directed by a doctor Children under 12 years of age: ask a doctor

⚠️ Warnings 52 words ▾

Liver warning: this product contains acetaminophen. Severe liver damage may occur if you take: more than 4000mg of acetaminophen 24 hours with other drugs containing acetaminophen 3 or more alcohol drinks every day while using this product Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash

🆘 Overdosage 51 words ▾

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222.

🧪 Active Ingredient 13 words ▾

Active Ingredients (in each tablet): Acetaminophen 325mg Phenylephrine HCl 5mg Chlorpheniramine Maleate 2mg

🧪 Inactive Ingredients 13 words ▾

corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelantined starch, stearic acid

🎯 Purpose 7 words ▾

Purpose: Pain Reliever/Fever Reducer Antihistamine Nasal Decongestant

📄 Do Not Use 56 words ▾

Do not use: with any other drug containing acetaminophen (prescription or non-prescription) 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, or if you do not know if your prescription drug contains an MAOI

📄 Ask a Doctor Before Use If 35 words ▾

Ask a doctor before use if you have heart, liver, or thyroid disease high blood pressure diabetes glaucoma trouble urinating due to an enlarged prostate gland a breathing problem such as emphysema or chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 34 words ▾

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers you are taking the blood thinning drug warfarin you do not know if other drugs you are taking contain acetaminophen

📄 When Using This Product 36 words ▾

When using this product to not use more than directed. This product may cause excitability or drowsiness. Alcohol, sedatives and tranquilizers may increase the drowsiness effect. Use caution when driving a motor vehicle or operating machinery.

📄 Stop Use and Ask a Doctor If 58 words ▾

Stop use and ask a doctor if an allergic reaction occurs, seek medical help right away you get nervous, dizzy or sleepless new symptom occur fever worsens or lasts for more than 3 days pain or nasal congestion gets worse or lasts more than 7 days redness or swelling is present These could be signs of serious condition

🤰 If Pregnant or Breast-Feeding 10 words ▾

If pregnant or breast-feeding, ask a health professional before use.

📄 Keep Out of Reach of Children 6 words ▾

Keep out of reach of children.

📄 Package Label / Principal Display Panel 1 words ▾

ReliefPEv24f.jpg

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 ✓ 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 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 HART Health. 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 1 other package presentation of this same product, including 100 tablets (50332-0153-04). 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?
HART Health 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.
← 50332-0152-04 · HART 50332-0154-02 · HART →
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.