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COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet, 36-count — NDC 51467-0011-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet, 36-count — NDC 51467-011-02 (Billing 51467-0011-02)

by FORTUNE PHARMACAL COMPANY LIMITED · 3 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK

This is a package of 36 tablets of COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet from FORTUNE PHARMACAL COMPANY LIMITED, marketed since Jul 2025 and currently FDA-listed, this package's marketing is listed to end Jun 2029.

NDC 51467-0011-02
🏷️ FDA NDC (as labeled) 51467-011-02 billing pads the product segment with a zero
This package
Contains36-count Pack sizes2 compare ↓
Product page 51467-0011-01 Also comes in: 24 tablets 51467-011-01
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 51467-011-02
Product NDC 51467-011
11-digit billing NDC 51467001102
Application # M012
SPL Set ID 687c82eb-0a0a-44d1-8283-21a2deb4c1f7
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 2025-07-01
Marketing end 2029-06-30
Route ORAL
Dosage form TABLET
Substance ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 51467-011-02 — 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 → 51467-0011-02. 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.

Clinical

🧪 What is this product?

Coltalin is an over-the-counter tablet taken by mouth that combines three active ingredients commonly used to manage cold and allergy symptoms. Acetaminophen is typically used as a pain reliever and fever reducer. Chlorpheniramine maleate functions as an antihistamine to help relieve allergy symptoms such as sneezing and itching. Phenylephrine hydrochloride is commonly used as a nasal decongestant to help relieve congestion. This product is marketed under the FDA's over-the-counter monograph rules for cold and allergy medicines.

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: 24 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
51467-0011-01 51467-011-01 Main listing 2 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK 2025-07-01 Jun 30, 2029 Active
51467-0011-02 You're viewing this 3 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK 2025-07-01 Jun 30, 2029 Active

Pack size FAQ

What quantity is in this package?
This is a 36-count package — 3 blister pack in 1 box / 12 tablet in 1 blister pack.
How does this package differ from NDC 51467-0011-01?
Both are COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet — the drug itself is identical. This page's package is the 36-count one, while NDC 51467-0011-01 is the 24 tablets package.
What NDC number is used to bill for this package of COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 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
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 mg 50332-0153-04 HART 100 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 mgthis 51467-0011-02 FORTUNE 36 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

🏛️
2025
On the market since
Jul 2025
📍
2026
Currently FDA-listed
1 year 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 orange
ShapeRound
ImprintSHIELDTM
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 2968PHW8QP
    A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
  • 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 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 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 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 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.

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

The official label also statesInactive ingredients Microcrystalline Cellulose, corn starch, FD&C yellow no. 6 aluminum lake, sodium starch glycolate, Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Colloidal silicon dioxide, magnesium stearate,

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

LabelerFORTUNE PHARMACAL COMPANY LIMITED
FDA applicationM012 (OTC MONOGRAPH DRUG)
Labeler code51467
First marketedJul 2025
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 72 words ▾

Uses ■ temporarily relieves these symptoms due to a cold, the flu, or hay fever: ■ minor aches and pains ■ sore throat ■ headache ■ runny nose ■ sinus congestion and pressure ■ nasal congestion due to a cold or hay fever ■ runny nose ■ 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 100 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 Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin rash occurs, stop use and seek medical help right away.

Do not give to children under 6 years of age unless directed by doctor.

📦 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 16 words ▾

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

🧪 Inactive Ingredients 25 words ▾

Inactive ingredients Microcrystalline Cellulose, corn starch, FD&C yellow no. 6 aluminum lake, sodium starch glycolate, Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Colloidal silicon dioxide, magnesium stearate,

🎯 Purpose 7 words ▾

Purpose Pain reliever-fever reducer Antihistamine Nasal decongestant

📄 Do Not Use 81 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. ■ 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 whether a prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

📄 Ask a Doctor Before Use If 51 words ▾

Ask a doctor before use if the user has ■ heart disease ■ high blood pressure ■ diabetes ■ glaucoma ■ liver disease ■ thyroid disease ■ a high fever ■ a breathing problem such as emphysema or chronic bronchitis ■ difficulty in urination due to enlargement of the prostate gland

📄 Ask a Doctor or Pharmacist Before Use If 23 words ▾

Ask a doctor or pharmacist before use if the user is ■ taking tranquilizers or sedatives ■ taking the blood thinning drug warfarin

📄 When Using This Product 42 words ▾

When using this product ■ do not exceed recommended dosage ■ may cause excitability especially in children ■ use caution when driving or operating machinery ■ avoid alcoholic beverages ■ may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect

📄 Stop Use and Ask a Doctor If 99 words ▾

Stop use and ask a doctor if ■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ■ sore throat persists for more than 2 days ■ fever gets worse or lasts more than 3 days ■ nasal congestion is accompanied by fever ■ nervousness, dizziness, or sleeplessness occur ■ redness or swelling is present ■ new symptoms occur ■ any of the following occurs (these could be signs of a serious condition): ■ severe sore throat ■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting

🤰 If Pregnant or Breast-Feeding 10 words ▾

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

📄 Keep Out of Reach of Children 42 words ▾

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 23 words ▾

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm ■ you may also report serious side effects to this phone number

📄 Package Label / Principal Display Panel 120 words ▾

COLTALIN Safely Sealed NDC 51467-011-02 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine maleate - Antihistamine Phenylephrine hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage ■ Sneezing, Runny Nose ■ Itchy, Watery Eyes 36 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF CARTON

COLTALIN Safely Sealed NDC 51467-011-01 Acetaminophen - Pain Reliever-Fever Reducer Chlorpheniramine maleate - Antihistamine Phenylephrine hydrochloride - Nasal Decongestant Cold, Flu & Hay Fever Multi-Symptom Relief ■ Minor Aches & Pain, Sore Throat ■ Headache, Fever ■ Nasal Congestion, Sinus Pressure/Drainage ■ Sneezing, Runny Nose ■ Itchy, Watery Eyes 24 Tablets In Individually Sealed Strip Aspirin Free IMAGE OF CARTON

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) ✓ 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 it is currently marketed — but FORTUNE PHARMACAL COMPANY LIMITED has reported a marketing end date of 2029-06-30, after which this package is expected to stop being marketed. 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 24 tablets (51467-0011-01). 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.
← 51467-0010-01 · FORTUNE 51467-0012-01 · 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.