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Childrens Coltalin Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride 80 mg; .5 mg; 1.25 mg Tablet, Chewable, 24-count — NDC 51467-006-01 (Billing 51467-0006-01)

by FORTUNE PHARMACAL COMPANY LIMITED · 24 TABLET, CHEWABLE in 1 CARTON

This is a package of 24 tablets of Childrens Coltalin Acetaminophen, Chlorpheniramine Maleate, Phenylephrine Hydrochloride 80 mg; .5 mg; 1.25 mg Tablet, Chewable from FORTUNE PHARMACAL COMPANY LIMITED, no longer marketed (first marketed Mar 2004), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 51467-0006-01
🏷️ FDA NDC (as labeled) 51467-006-01 billing pads the product segment with a zero
OTC Discontinued Non-controlled ⚠ Discontinued by firm ⇄ 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2024. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51467-006-01
Product NDC 51467-006
11-digit billing NDC 51467000601
RxCUI 1540507
UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Application # M012
SPL Set ID 98748cbc-b567-4ef9-b7f7-fe74645935d4
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 Discontinued
FDA listing status Discontinued by firm (certified through Dec 2024)
Marketing start 2004-03-01
Route ORAL
Dosage form TABLET, CHEWABLE
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Quick answers
  • RxCUI (RxNorm): 1540507
Why two NDCs? The FDA registers this code as 51467-006-01 — 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 → 51467-0006-01. 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.

Clinical

🧪 What is this product?

This is a chewable tablet for children that combines three active ingredients. Acetaminophen is typically used to reduce fever and relieve minor aches and pains. Chlorpheniramine maleate is an antihistamine commonly used to help relieve allergy symptoms such as sneezing and runny nose. Phenylephrine hydrochloride is a decongestant typically used to help relieve nasal congestion. This product is an over-the-counter monograph drug, meaning it is marketed under FDA guidelines for its drug category rather than through an individual application review.

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
51467-0006-01 You're viewing this Main listing 24 TABLET, CHEWABLE in 1 CARTON 2004-03-01 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Childrens Coltalin 80 mg/1; .5 mg/1; 1.25 mgthis 51467-0006-01 FORTUNE 24 tablets — — Discontinued —
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

🏛️
2004
On the market since
Mar 2004
📍
2026
Currently FDA-listed
22 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

LabelerFORTUNE PHARMACAL COMPANY LIMITED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51467
First marketedMar 2004
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.

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 📄 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 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 51 words ▾

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

⏱️ Dosage and Administration 46 words ▾

Directions children 6 to under 12 years of age: Chew tablet before swallowing. 4 tablets every 4 hours while symptoms persist, not to exceed 5 doses (20 tablets) in 24 hours, or as directed by a doctor children under 6 of age : consult a doctor

⚠️ Warnings 36 words ▾

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses in 24 hours, which the maximum daily amount for this product with other drugs containing acetaminophen

📦 Storage and Handling 26 words ▾

Other information Phenylketonurics: contains Phenylalanine 4.2mg per tablet protect from light store between 15 to 30 C (59 to 86 F) keep in a dry place

🧪 Active Ingredient 16 words ▾

Active ingredients (in each tablet) Acetaminophen 80 mg Chlorpheniramine maleate 0.5 mg Phenylephrine hydrochloride 1.25 mg

🧪 Inactive Ingredients 20 words ▾

Inactive ingredients Aspartame, citric acid, corn starch, FDC yellow no. 6 aluminum lake, magnesium stearate, mannitol, pineapple flavor, povidone K30

🎯 Purpose 7 words ▾

Purpose Pain reliever-fever reducer Antihistamine Nasal decongestant

📄 Do Not Use 75 words ▾

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. in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease). If you do not know whether a prescription drug contains an MAOI, ask a doctor or pharmacist. for 2 weeks after stopping the MAOI drug

📄 Ask a Doctor Before Use If 27 words ▾

Ask a doctor before use if the user has liver disease heart disease high blood pressure thyroid disease diabetes glaucoma a breathing problem such as chronic bronchitis

📄 Ask a Doctor or Pharmacist Before Use If 35 words ▾

Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin taking sedatives or tranquilizers taking a prescription drug and you do not know if it contains an MAOI

📄 When Using This Product 26 words ▾

When using this product do not exceed recommended dosage may cause drowsiness (sedatives and tranquilizers may increase the drowsiness effect) may cause excitability especially in children

📄 Stop Use and Ask a Doctor If 66 words ▾

Stop use and ask a doctor if sore throat persists for more than 2 days sore throat is severe sore throat is accompanied or followed by: fever, headache, rash, nausea, vomitting pain or nasal congestion gets worse or lasts more than 5 day fever gets worse or lasts more than 3 days redness or swelling is presen new symptoms occur if nervousness, dizziness, or sleeplessness occur

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 57 words ▾

Do not give to children under 6 years of age unless directed by a doctor. Keep out of reach of children. 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 children even if you do not notice any signs or symptoms.

📄 Questions or Comments 29 words ▾

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm you may also use this number to report serious adverse events associated with the use of this product

📄 Package Label / Principal Display Panel 50 words ▾

Children's Coltalin NDC 51467-006-01 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine maleate - Antihistamine Phenylephrine hydrochloride- Decongestant See new warnings information Sugar Free Aspirin Free 24 Chewable Tablets Safety Sealed Do not use if individually sealed foil unit dose pouches are torn, broken, or shows the evidence of being opened. Box1

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 CHILDRENS COLTALIN (this brand).

Top reported reactions

Foreign Body In Throat1

Reporter sex

1 reports
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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
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.
← 51467-0005-01 · FORTUNE 51467-0007-01 · 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.