Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
SPRINSOL Chlorpheniramine maleate 4 mg Tablet, 24-count — NDC 51467-101-01 (Billing 51467-0101-01)
by FORTUNE PHARMACAL COMPANY LIMITED · 2 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK
This is a package of 24 tablets of SPRINSOL Chlorpheniramine maleate 4 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. It is the main listing for this product, which comes in 2 package sizes.
NDC 51467-0101-01
🏷️ FDA NDC (as labeled)
51467-101-01
billing pads the product segment with a zero
This package
Contains24-count
Pack sizes2 compare ↓
Main listing for product 51467-101 · Also comes in:
36 tablets 51467-101-02
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
NDC database record
One package, one record: these facts belong to NDC 51467-101-01 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 51467 labeler · 101 product · 01 package
- Package marketed since
- Jul 1, 2025
- Package marketing ended
- Jun 30, 2029
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 5146710101 5
- FDA record last changed
- Oct 8, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
51467-101-01
Product NDC
51467-101
11-digit billing NDC
51467010101
Application #
M012
SPL Set ID
01a1a91e-04ba-4526-8946-10483932b30c
Established class (EPC)
Histamine-1 Receptor Antagonist
Mechanism of action
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
CHLORPHENIRAMINE MALEATE
Why two NDCs?
The FDA registers this code as 51467-101-01 — 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 → 51467-0101-01. 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
Clinical
📖 What it is MedlinePlus · NLM
Chlorpheniramine is used to treat allergy symptoms: sneezing runny nose itchy nose or throat red, itchy, watery eyes Chlorpheniramine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
Read the full MedlinePlus article ↗📗 Our plain-language guide HelloPharmacist
- It temporarily relieves allergy symptoms from hay fever and other upper respiratory allergies. That means sneezing, runny nose, itchy, watery eyes, and an itchy nose or throat. It...
- It depends on the product. Regular tablets and the liquid are generally taken every 4 to 6 hours. The extended-release tablets are taken about every 12 hours. Check your package fo...
- It can, and the drowsiness may be marked. Be careful driving or using machinery. Some people, especially children, can get excitable instead.
- It's best to avoid alcohol, since it adds to drowsiness. Sedatives and tranquilizers can also increase drowsiness, so talk to me or your doctor before taking them together.
Patient education
Supplement & herbal interactions
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.
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
💬 Questions about Chlorpheniramine maleate?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
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 system | Per each | Per 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.
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 51467-0101-01 You're viewing this Main listing | 2 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK | 2017-09-22 | Jun 30, 2029 | Active |
| 51467-0101-02 51467-101-02 | 3 BLISTER PACK in 1 BOX / 12 TABLET in 1 BLISTER PACK | 2017-09-22 | Jun 30, 2029 | Active |
Pack size FAQ
What quantity is in this package?
This is a 24-count package — 2 blister pack in 1 box / 12 tablet in 1 blister pack.
How does this package differ from NDC 51467-0101-02?
Both are SPRINSOL Chlorpheniramine maleate 4 mg Tablet — the drug itself is identical. This page's package is the 24-count one, while NDC 51467-0101-02 is the 36 tablets package.
What NDC number is used to bill for this package of SPRINSOL Chlorpheniramine maleate 4 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
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Allergy Relief 4 Hour 4 mg 70000-0160-01 | Cardinal | 24 tablets | $0.018 | — | Discontinued | — |
| Allergy 4 mg 00904-0012-24 | Major | 24 tablets | $0.018 | — | Availability likely | — |
| Allergy Relief 4 mg 46122-0618-62 | Amerisource | 24 tablets | $0.018 | — | Availability likely | — |
| Allergy Relief 4 mg 70677-1016-01 | Strategic | 100 tablets | $0.018 | — | Availability likely | — |
| Allergy Relief 4 mg 83324-0068-24 | Chain | 24 tablets | $0.018 | — | Availability likely | — |
| Aller-chlor 4 mg 00536-1006-01 | Rugby | 100 tablets | $0.018 | — | Availability likely | — |
| Allergy Relief 4 mg 00363-1941-15 | Walgreen | 50 tablets | — | — | FDA listed | — |
| allergy relief 4 mg 11822-0662-01 | Rite | 100 tablets | — | — | FDA listed | — |
| Anti Allergy 4 mg 17714-0016-01 | Advance | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 36800-0694-08 | Topco | 24 tablets | — | — | FDA listed | — |
| Allergy 4 mg 37835-0633-01 | Bi-Mart | 100 tablets | — | — | FDA listed | — |
| Allergy 4 mg 41163-0194-08 | United | 24 tablets | — | — | FDA listed | — |
| Medique Chlorphen 4 mg 47682-0169-46 | Unifirst | 1 tablet | — | — | FDA listed | — |
| Allergy Time 4 mg 49483-0242-00 | Time | 100000 tablets | — | — | FDA listed | — |
| Allergy 4 mg 50090-0049-00 | A-S | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 50804-0277-93 | Good | 24 tablets | — | — | FDA listed | — |
| Sprinsol 4 mgthis 51467-0101-01 | FORTUNE | 24 tablets | — | — | FDA listed | — |
| Chlorpheniramine maleate 4mg 4 mg 53185-0277-24 | Athlete's | 24 tablets | — | — | FDA listed | — |
| Anti Allergy 4 mg 54738-0103-01 | Richmond | 100 tablets | — | — | FDA listed | — |
| Chlorpheniramine Maleate 4 mg 55289-0560-01 | PD-Rx | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 4 Hour 4 mg 57896-0974-01 | Geri-Care | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 63868-0333-24 | CHAIN | 24 tablets | — | — | FDA listed | — |
| Allergy Relief 4 Hour 4 mg 67091-0203-24 | WinCo | 24 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 68016-0683-81 | Chain | 100 tablets | — | — | FDA listed | — |
| Allergy 4 mg 68998-0277-93 | Marc | 24 tablets | — | — | FDA listed | — |
| Allergy 4 mg 69168-0277-93 | Allegiant | 24 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 69842-0194-12 | CVS | 100 tablets | — | — | FDA listed | — |
| Chlorpheniramine Maleate 4 mg 71335-0963-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Allergy 4 mg 71335-2056-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 71335-2812-01 | Bryant | 100 tablets | — | — | FDA listed | — |
| Allergy Relief 4 Hour 4 mg 71335-3093-01 | Bryant | 30 tablets | — | — | FDA listed | — |
| Pharbechlor 4 mg 73057-0346-11 | Ulai | 1000 tablets | — | — | FDA listed | — |
| Allergy Relief 4 mg 79903-0074-12 | WALMART | 100 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.
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
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.
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Color
red
ShapeRound
ImprintFORTUNE
Size10 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.
- FDA label on DailyMed · label index refreshed Oct 6, 2026
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.
🧪 Avoiding an ingredient? See Chlorpheniramine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
-
UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
-
UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
-
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 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.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesInactive ingredients colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate
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.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
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
More NDCs from FORTUNE PHARMACAL COMPANY LIMITED labeler code 51467
- Extra Fast Coltalin Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet NDC 51467-010-01
- COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet NDC 51467-011-01
- COLTALIN-DM Acetaminophen, Chlorpheniramine maleate, Dextromethorphan Hydrobromide, Phenylephrine hydrochloride 325 mg; 2 mg; 10 mg; 5 mg Tablet NDC 51467-012-01
- COLTALIN-ND Acetaminophen, Phenylephrine hydrochloride 325 mg; 5 mg Tablet NDC 51467-013-01
- EXTRA FAST COLTALIN Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride 325 mg; 2 mg; 5 mg Tablet NDC 51467-014-01
- MAGSIL ANTACID (LEMON MINT) Aluminum Hydroxide Dried Gel, Magnesium Hydroxide, and Simethicone 200 mg; 200 mg; 21 mg Tablet, Chewable NDC 51467-100-01
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 openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
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
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
📄 Ask a Doctor or Pharmacist Before Use If
📄 When Using This Product
🤰 If Pregnant or Breast-Feeding
📄 Keep Out of Reach of Children
📄 Other Information
📄 Questions or Comments
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes
⏱️ Dosage and Administration ▾
Directions adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours, not to exceed 6 tablets (24 mg) in 24 hours, or as directed by a doctor children under 12 years of age: consult a doctor
⚠️ Warnings ▾
Warnings Ask a doctor before use if you have a breathing problem such as emphysema or chronic bronchitis glaucoma difficulty in urination due to enlargement of the prostate gland
🧪 Active Ingredient ▾
Active ingredients (in each tablet) Chlorpheniramine maleate 4 mg
🧪 Inactive Ingredients ▾
Inactive ingredients colloidal silicon dioxide, corn starch, FD C red no. 40 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate
🎯 Purpose ▾
Purpose Antihistamine
📄 Ask a Doctor or Pharmacist Before Use If ▾
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
📄 When Using This Product ▾
When using this product do not exceed recommended dosage unless directed by a physician 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
🤰 If Pregnant or Breast-Feeding ▾
If pregnant or breast-feeding, ask a health professional before use.
📄 Keep Out of Reach of Children ▾
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away
📄 Other Information ▾
Other information keep tightly sealed protect from light store between 20 to 25 C (68 to 77 F)
📄 Questions or Comments ▾
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 ▾
Sprinsol Safely Sealed NDC 51467-101-02 Chlorpheniramine maleate - Antihistamine temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies: sneezing runny nose itching of the nose or throat itchy, watery eyes 36 Tablets In Individually Sealed Strip Respiratory Series IMAGE OF CARTON
No label section mentions that — try another word, or open the full label on DailyMed below.
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 Chlorpheniramine maleate — the ingredient across all brands.
Top reported reactions
Age at onset
Reporter sex
Male · 33%
Female · 66%
Unknown · 0%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 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 36 tablets (51467-0101-02). 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.
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.