Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.
Allergy Time Chlorpheniramine Maleate 4 mg Tablet, 100,000-count — NDC 49483-242-00 (Billing 49483-0242-00)
by Time Cap Labs Inc · 100000 TABLET in 1 CARTON
This is a package of 100,000 tablets of Allergy Time Chlorpheniramine Maleate 4 mg Tablet from Time Cap Labs Inc, marketed since Feb 2011 and currently FDA-listed.
NDC 49483-0242-00
🏷️ FDA NDC (as labeled)
49483-242-00
billing pads the product segment with a zero
This package
Contains100,000-count
Pack sizes4 compare ↓
Product page 49483-0242-01
Also comes in:
24 tablets 49483-242-24
100 tablets 49483-242-01
1000 tablets 49483-242-10
🗂️ FDA directory synced Oct 8, 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 →
NDC database record
One package, one record: these facts belong to NDC 49483-242-00 alone.
- Record
- FDA NDC Directory package listing · Human OTC drug
- Code segments
- 49483 labeler · 242 product · 00 package
- Package marketed since
- Dec 17, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0349483242010
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
FDA NDC (as labeled)
49483-242-00
Product NDC
49483-242
11-digit billing NDC
49483024200
RxCUI
1363309
UNII
V1Q0O9OJ9Z
UPC
0349483242010
Application #
part341
SPL Set ID
588c424a-8dd6-417e-8f76-2ce0cc2b0c12
Established class (EPC)
Histamine-1 Receptor Antagonist
Mechanism of action
Histamine H1 Receptor Antagonists
DEA schedule
Non-controlled
Marketing category
OTC MONOGRAPH FINAL
Marketing status
On market
FDA listing status
Listed (active directory)
Marketing start
2011-02-08
Route
ORAL
Dosage form
TABLET
Substance
CHLORPHENIRAMINE MALEATE
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
GPI-14
41100020150310
GPI class
Allergy-Time
GCN Seq No
011640
GCN
46512
HICL code
004505
Ingredient (HICL)
Chlorpheniramine Maleate
HIC1 code
Z
Therapeutic class — broad (HIC1)
Body As A Whole
HIC2 code
Z2
Therapeutic class — intermediate (HIC2)
Antihistamines, Antiserotonins, Immunosuppressants
HIC3 code
Z2P
Therapeutic class — specific (HIC3)
Antihistamines - 1St Generation
AHFS code
04:04.00.00
AHFS class
First Generation Antihistamines
FDB label name
ALLERGY-TIME 4 MG TABLET
FDB brand name
Allergy-Time
Legend status
O — Over-the-counter (OTC) drug or device
Quick answers
- GSN (GCN sequence number): 011640
- GCN: 46512
- GPI-14 (Medi-Span): 41100020150310
- HICL (First Databank): 004505
- AHFS class code: 04:04.00.00
- RxCUI (RxNorm): 1363309
Why two NDCs?
The FDA registers this code as 49483-242-00 — 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 → 49483-0242-00. 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 8, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 8, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Histamine-1 Receptor Antagonist class.
Pharmacologic class
Histamine-1 Receptor Antagonist
Drug family (ATC)
Substituted alkylamines
How it works
Histamine H1 Receptor Antagonists
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.
- RxClass (NLM) · catalog refreshed Oct 8, 2026
Clinical
Label name ALLERGY-TIME 4 MG TABLET Ingredient Chlorpheniramine Maleate
📖 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 8, 2026
- FDA label on DailyMed · label index refreshed Oct 8, 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.
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 9, 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 | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 49483-0242-00 You're viewing this | 100000 TABLET in 1 CARTON | — | — | 2018-12-17 | — | Active |
| 49483-0242-01 49483-242-01 Main listing | 100 TABLET in 1 BOTTLE, PLASTIC | $0.0177 / ea | $1.77 | 2018-12-17 | — | Active |
| 49483-0242-10 49483-242-10 | 1000 TABLET in 1 BOTTLE, PLASTIC | $0.0177 / ea | $17.72 | 2018-12-17 | — | Active |
| 49483-0242-24 49483-242-24 | 24 TABLET in 1 BLISTER PACK | — | — | 2018-12-17 | — | Active |
You're viewing the largest of 4 pack sizes for this product.
Pack size FAQ
What quantity is in this package?
This is a 100,000-count package — 100000 tablet in 1 carton.
How does this package differ from NDC 49483-0242-24?
Both are Allergy Time Chlorpheniramine Maleate 4 mg Tablet — the drug itself is identical. This page's package is the 100,000-count one, while NDC 49483-0242-24 is the 24 tablets package.
What NDC number is used to bill for this package of Allergy Time 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.
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
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 mgthis 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 mg 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 9, 2026
- CMS NADAC weekly file
Availability & generic status
🏛️
2011
On the market since
Feb 2011
📍
2026
Currently FDA-listed
15 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.
- FDA Orange Book · refreshed Oct 9, 2026
What it looks like
Color
yellow
ShapeRound
ImprintTCL242
Size8 mm
ScoringScored — splits in 2
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 8, 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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
-
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 M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
-
UNII 35SW5USQ3G
A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
-
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 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 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
7 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesanhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
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 8, 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
LabelerTime Cap Labs Inc
FDA applicationpart341 (OTC MONOGRAPH FINAL)
Labeler code49483
First marketedFeb 2011
Product typeHuman Otc Drug
Portfolio6 products on file
More NDCs from Time Cap Labs Inc labeler code 49483
- Ibuprofen 200 mg Tablet, Film Coated NDC 49483-114-10
- Ibuprofen 200 mg Capsule, Liquid Filled NDC 49483-133-12
- Nitro-Time Nitroglycerin 2.5 mg Capsule NDC 49483-221-06
- Nitro-Time Nitroglycerin 6.5 mg Capsule NDC 49483-222-06
- Nitro-Time Nitroglycerin 9 mg Capsule NDC 49483-223-06
- Pseudo Time PE Phenylephrine Hchloride 10 mg Tablet, Film Coated NDC 49483-234-00
- Mucosa Guaifenesin 400 mg Tablet NDC 49483-272-00
- Mucosa DM Guaifenesin Dextromethorphan 400 mg; 20 mg Tablet NDC 49483-280-00
- Low Dose Aspirin Enteric Safety Coated 81 mg Tablet, Delayed Release NDC 49483-328-01
- Diphenhydramine Hydrochloride 25 mg Tablet, Coated NDC 49483-329-00
- Low Dose Miniprin Enteric Safety Coated Aspirin 81 mg Tablet, Delayed Release NDC 49483-330-10
- Enteric Coated Aspirin Regular Strength 325 mg/3251 Tablet, Delayed Release NDC 49483-331-00
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
📄 Package Label / Principal Display Panel
🎯 Indications and Usage ▾
Uses: temporarily relieves the following symptoms due to hay fever or other upper respiratory allergies: runny nose, sneezing, itching of the nose or throat, itch, watery eyes
⏱️ Dosage and Administration ▾
Directions Adults and children 12 years and over - 1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours Children 6 to under 12 years of age - 1/2 tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours Children under 6 years of age - do not use
⚠️ Warnings ▾
Warnings Ask a doctor before use if you have: glaucoma; a breathing problem such as emphysema or chronic bronchitis; difficulty urinating due to an enlarged prostate gland
🧪 Active Ingredient ▾
Active ingredient (in each tablet) Chlorpheniramine maleate 4 mg
🧪 Inactive Ingredients ▾
anhydrous lactose, colloidal silicon dioxide, croscarmellose sodium, D-C yellow #10 aluminum lake, magnesium stearate, microcrystalline cellulose, stearic acid.
🎯 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: excitability may occur, especially in children; drowsiness may occur; avoid alcoholic beverages; alcohol, sedatives and tranquilizers may increase drowsiness; use caution when driving a motor vehicle operating machinery
🤰 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 the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📄 Package Label / Principal Display Panel ▾
100 CT LABEL
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 Allergy Time (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 42%
Female · 58%
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 Final". 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 Time Cap Labs Inc. 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 3 other package presentations of this same product, including 24 tablets (49483-0242-24), 100 tablets (49483-0242-01), 1000 tablets (49483-0242-10). 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?
Time Cap Labs Inc 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.