Home › NDC Lookup › Ingredients › Acetaminophen, Chlorpheniramine Maleate,... › 51467-0007-01
COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 325 mg; 2 mg; 10 mg; 5 mg Tablet, 24-count — NDC 51467-0007-01 package photo

COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 325 mg; 2 mg; 10 mg; 5 mg Tablet, 24-count

by FORTUNE PHARMACAL COMPANY LIMITED · 2 BLISTER PACK in 1 BOX (51467-007-01) / 12 TABLET in 1 BLISTER PACK
NDC 51467-0007-01
🏷️ FDA NDC (as labeled) 51467-007-01 billing pads the product segment with a zero
This package
Contains24-count Pack sizes2 compare ↓
Also comes in: 36 tablets 51467-0007-02
OTC On market Non-controlled
🗂️ Data synced Sep 10, 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) 51467-007-01
Product NDC 51467-007
11-digit billing NDC 51467000701
RxCUI 1086991
UNII 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ
Application # M012
SPL Set ID 8b1138f2-aad0-43ef-80d4-e36f92fe5e93
Established class (EPC) Histamine-1 Receptor Antagonist; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist; Uncompetitive NMDA Rece
Mechanism of action Adrenergic alpha1-Agonists; Histamine H1 Receptor Antagonists; Sigma-1 Receptor Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-01-30
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 51467-007-01 — 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 → 51467-0007-01. 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

LabelerFORTUNE PHARMACAL COMPANY LIMITED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51467
First marketedJan 2026
Product typeHuman Otc Drug
Portfolio11 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?

Coltalin-DM is an over-the-counter oral tablet that combines four active ingredients commonly used to address cold and flu symptoms. Acetaminophen is typically used to reduce fever and relieve pain, while dextromethorphan functions as a cough suppressant. Chlorpheniramine maleate is an antihistamine commonly used to reduce sneezing, itching, and runny nose, and phenylephrine hydrochloride is a decongestant typically used to relieve nasal congestion. This product is marketed as an OTC monograph drug under established FDA guidelines for combination cold remedies.

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 yellow
ShapeRound
ImprintFORTUNE
Size12 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.

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 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: 36 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Cold Max Nighttime 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 36800-0914-02 TopCo 12 tablets — — FDA listed —
Cold Plus Head Congestion Nighttime 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 36800-0925-02 TopCo 12 tablets — — FDA listed —
Coltalin-Dm 325 mg/1; 2 mg/1; 10 mg/1; 5 mgthis 51467-0007-01 FORTUNE 24 tablets — — FDA listed —
Coltalin-Dm 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 51467-0012-01 FORTUNE 24 tablets — — FDA listed —
Cold Max Nighttime 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 53943-0239-02 DISCOUNT 12 tablets — — FDA listed —
Multi-Symptom Cold 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 63941-0473-08 Valu 12 tablets — — FDA listed —
Cold Multi-Symptom Nighttime 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 68998-0139-02 Marc 12 tablets — — FDA listed —
Cold Multi-Symptom Night-time 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 69168-0319-86 Allegiant 12 tablets — — FDA listed —
Cold Max Nighttime 325 mg/1; 2 mg/1; 10 mg/1; 5 mg 72476-0239-02 RETAIL 12 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

🏛️
2026
On the market since
Jan 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.

🔬 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, Dextromethorphan Hydrobromide, Phenylephrine hydrochloride — the ingredient across all brands.

Top reported reactions

Hypoxia2
Organising Pneumonia2
Pneumonia Influenzal2

Reporter sex

2 reports
Male · 100%

Serious outcomes

Hospitalization2
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
51467-0007-01 You're viewing this 2 BLISTER PACK in 1 BOX (51467-007-01) / 12 TABLET in 1 BLISTER PACK 2004-03-01 Active
51467-0007-02 3 BLISTER PACK in 1 BOX (51467-007-02) / 12 TABLET in 1 BLISTER PACK 2016-04-26 Active

Pack size FAQ

What quantity is in NDC 51467-0007-01?
NDC 51467-0007-01 is a 24-count package — 2 blister pack in 1 box / 12 tablet in 1 blister pack.
What is the difference between NDC 51467-0007-01 and NDC 51467-0007-02?
Both are COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 325 mg; 2 mg; 10 mg; 5 mg Tablet — the drug itself is identical. NDC 51467-0007-01 is the 24-count package, while NDC 51467-0007-02 is the 36 tablets package.
What NDC number is used to bill for this package of COLTALIN-DM ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE 325 mg; 2 mg; 10 mg; 5 mg Tablet?
Bill NDC 51467-0007-01 — the 11-digit billing format is 51467000701. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 FDA registers it as 51467-007-01, 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: 51467-0007-01, written without dashes as 51467000701. 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 51467-0007-01, the first segment (51467) is the labeler code FDA assigned to FORTUNE PHARMACAL COMPANY LIMITED; the middle segment (0007) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) 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 FORTUNE PHARMACAL COMPANY LIMITED. 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 36 tablets (51467-0007-02). 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?
FORTUNE PHARMACAL COMPANY LIMITED 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 71 words ▾

Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■ minor aches and pains ■ headache ■ sore throat ■ nasal congestion ■ runny nose ■ sinus congestion and pressure ■ cough due to minor throat and bronchial irritation ■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever ■ temporarily reduces fever ■ promotes nasal and/or sinus drainage

⏱️ Dosage and Administration 78 words ▾

Directions ■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor ■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor ■ children under 6 of age : consult a doctor

⚠️ Warnings 62 words ▾

Warnings Liver Warning: This product contains acetaminophen. Severe liver damage may occur if ■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product ■ child takes more than 5 doses in 24 hours ■ taken with other drugs containing acetaminophen ■ adult has 3 or more alcoholic drinks everyday while using this product

📦 Storage and Handling 22 words ▾

Other information ■ keep tightly sealed ■ store between below 25 C (77 F) in a dry place, away from direct sunlight

🧪 Active Ingredient 20 words ▾

Active ingredients (in each tablet) Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredient Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Corn starch, Microcrystalline Cellulose, D&C Yellow No.10 Aluminum Lake, Colloidal silicon dioxide, Magnesium stearate, Sodium Starch Glycolate.

🎯 Purpose 10 words ▾

Purpose ​s Pain reliever-fever reducer Antihistamine Cough suppressant Nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51467-0006-01 · FORTUNE 51467-0008-01 · FORTUNE →
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.