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PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE 10 mg Tablet, Film Coated, 18-count — NDC 49483-0234-18 package photo

PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE 10 mg Tablet, Film Coated, 18-count

by TIME CAP LABORATORIES, INC. · 18 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-18)
NDC 49483-0234-18
🏷️ FDA NDC (as labeled) 49483-234-18 billing pads the product segment with a zero
This package
Contains18-count Pack sizes3 compare ↓
Also comes in: 36 tablets 49483-0234-36 100000 tablets 49483-0234-00
OTC On market Non-controlled
🗂️ Data synced 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

🆔 Identity & classification

FDA NDC (as labeled) 49483-234-18
Product NDC 49483-234
11-digit billing NDC 49483023418
RxCUI 1049182
UNII 04JA59TNSJ
UPC 9333728234183
Application # part341
SPL Set ID 3116f273-0517-4755-95cd-be3a7c0dd76b
Established class (EPC) alpha-1 Adrenergic Agonist
Mechanism of action Adrenergic alpha1-Agonists
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-05-14
Route ORAL
Dosage form TABLET, FILM COATED
Substance PHENYLEPHRINE HYDROCHLORIDE
Why two NDCs? The FDA registers this code as 49483-234-18 — 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 → 49483-0234-18. 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 alpha-1 Adrenergic Agonist class.

Pharmacologic class alpha-1 Adrenergic Agonist
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Adrenergic and dopaminergic agents, Other agents for treatment of hemorrhoids and anal fissures for topical use
How it works Adrenergic alpha1-Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerTIME CAP LABORATORIES, INC.
FDA applicationpart341 (OTC MONOGRAPH FINAL)
Labeler code49483
First marketedMay 2012
Product typeHuman Otc Drug
Portfolio25 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Yes, it's the same active ingredient, but used in very different ways depending on the form. The nasal spray delivers a tiny amount directly to the nasal lining to temporarily shri...
  • I see phenylephrine in nasal sprays at the pharmacy AND as an IV drug in the hospital — is it really the same medication?
  • You should check with your doctor first. Phenylephrine constricts blood vessels, which can raise blood pressure and put extra strain on the heart — even from a nasal spray. If you...
  • Can I use the nasal spray if I have high blood pressure or heart disease?
📖 Read our full Phenylephrine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color red
ShapeRound
ImprintT234
Size7 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 R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • 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 O7TSZ97GEP
    A mineral compound that serves as a filler and binding agent in tablets and capsules. It adds bulk to the medicine and helps hold ingredients together during manufacturing.
  • 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 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 9B9691B2N9
    Magnesium silicate is a mineral compound used in tablets and capsules as a glidant and anti-caking agent. It helps powder ingredients flow smoothly during manufacturing and prevents clumping in the final product.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

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

The official label also statesINACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

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.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 36 tablets 100000 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nasal Decongestant PE Maximum Strength 10 mg 70677-1152-01 Strategic 18 tablets $0.050 — Availability likely —
Nasal Decongestant PE 10 mg 00363-4531-07 Walgreen 18 tablets — — FDA listed —
PhysiciansCare Sinus Non-Drowsy 10 mg 00924-0133-01 Acme 1 tablet — — FDA listed —
Sinus Pressure and Congestion Relief PE Maximum Strength 10 mg 11822-4530-02 Rite 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 21130-0453-07 Better 18 tablets — — FDA listed —
Sinus Decongestion PE 10 mg 30142-0534-07 Kroger 18 tablets — — FDA listed —
Sinus Congestion 10 mg 30142-0853-07 Kroger 18 tablets — — FDA listed —
PE Sinus Congestion 10 mg 36800-0704-07 Topco 18 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 37808-0453-23 H 24 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 37835-0651-01 Bi-Mart 100 tablets — — FDA listed —
Medi-First Sinus Decongestant 10 mg 47682-0809-13 Unifirst 1 tablet — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 47682-0990-33 Unifirst 1 tablet — — FDA listed —
Unishield Sinus Decongestant 10 mg 49314-2083-03 Unishield 1 tablet — — FDA listed —
Pseudo Time Pe 10 mgthis 49483-0234-18 TIME 18 tablets — — FDA listed —
Good Sense Nasal Decongestant PE 10 mg 50090-3659-00 A-S 36 tablets — — FDA listed —
Phenylephrine HCl Maximum Strength 10 mg 50090-5606-00 A-S 18 tablets — — FDA listed —
Nasal Decongestant Pe 10 mg 50090-7449-00 A-S 18 tablets — — FDA listed —
Sudafed PE Sinus Congestion 10 mg 50580-0437-01 Kenvue 18 tablets — — FDA listed —
Sinus Congestion 10 mg 50844-0493-08 L.N.K. 24 tablets — — FDA listed —
Suphedrine PE Sinus Congestion Non-Drowsy 10 mg 55301-0753-23 ARMY 24 tablets — — FDA listed —
SU PHEDRINE PE Non-Drowsy, Maximum Strength 10 mg 57243-0453-44 Salado 18 tablets — — FDA listed —
Su Phedrine Pe Sinus Congestion 10 mg 57243-0953-44 Salado 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 57631-0018-00 InvaTech 30000 tablets — — FDA listed —
Nasal Decongestant PE Non-Drowsy Maximum Strength 10 mg 63868-0144-19 CHAIN 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 67091-0207-18 WinCo 18 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength Non-Drowsy 10 mg 69168-0272-17 Allegiant 300 tablets — — FDA listed —
Redicare Nasal and Sinus Decongestant 10 mg 71105-0272-02 Redicare 100 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0025-01 Pioneer 300 tablets — — FDA listed —
Gencare-Nasal Decongestant PE 10 mg 72090-0039-01 Pioneer 300 tablets — — FDA listed —
Crane Safety Sinus Decongestant 10 mg 73408-0990-33 Crane 1 tablet — — FDA listed —
ValuMeds Nasal Decongestant Phenylephrine HCl 10 mg 82725-1111-01 Cabinet 300 tablets — — FDA listed —
Goodmeds Non-Drowsy Nasal Decongestant PE 10 mg 82725-4111-01 Cabinet 365 tablets — — FDA listed —
Sinus Congestion 10 mg 83324-0073-18 Chain 18 tablets — — FDA listed —
Phenylephrine Hydrochloride 10 mg 83586-0010-00 HHH 130000 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 83586-0160-01 HHH 100 tablets — — FDA listed —
Nasal Decongestant PE 10 mg 84324-0010-01 NUVICARE 100 tablets — — FDA listed —
Nasal Decongestant PE Maximum Strength 10 mg 85766-0178-18 Sportpharm 18 tablets — — FDA listed —
Medi-First Plus Sinus Decongestant 10 mg 85766-0182-01 Sportpharm 1 tablet — — 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

🏛️
2012
On the market since
May 2012
📍
2026
Currently FDA-listed
14 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49483-0234-00 100000 TABLET, FILM COATED in 1 CARTON (49483-234-00) 2018-12-14 Active
49483-0234-18 You're viewing this 18 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-18) 2018-12-14 Active
49483-0234-36 36 TABLET, FILM COATED in 1 BLISTER PACK (49483-234-36) 2018-12-14 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 49483-0234-18?
NDC 49483-0234-18 is a 18-count package — 18 tablet, film coated in 1 blister pack.
What is the difference between NDC 49483-0234-18 and NDC 49483-0234-36?
Both are PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE 10 mg Tablet, Film Coated — the drug itself is identical. NDC 49483-0234-18 is the 18-count package, while NDC 49483-0234-36 is the 36 tablets package.
What NDC number is used to bill for this package of PSEUDO TIME PE PHENYLEPHRINE HCHLORIDE 10 mg Tablet, Film Coated?
Bill NDC 49483-0234-18 — the 11-digit billing format is 49483023418. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ 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 FDA registers it as 49483-234-18, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49483-0234-18, written without dashes as 49483023418. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49483-0234-18, the first segment (49483) is the labeler code FDA assigned to TIME CAP LABORATORIES, INC.; the middle segment (0234) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (18) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by TIME CAP LABORATORIES, 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 2 other package presentations of this same product, including 36 tablets (49483-0234-36), 100000 tablets (49483-0234-00). 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 LABORATORIES, 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.

📄 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
🎯 Indications and Usage 29 words ▾

Uses: Temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies and nasal congestion associated with sinusitis Temporarily relieves sinus congestion and pressure

⏱️ Dosage and Administration 35 words ▾

DIRECTIONS: Take every 4 hours; Do not take more than 6 doses in 24 hours; Adults and children 12 years of age and over; 1 tablet Children under 12 years of age; ask a doctor

⚠️ Warnings 55 words ▾

WARNINGS; Do not use if you are 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 if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

🧪 Active Ingredient 7 words ▾

Each tablet contains: Phenylephrine HCl 10 mg

🧪 Inactive Ingredients 31 words ▾

INACTIVE INGREDIENTS: CARNAUBA WAX, CROSCARMELLOSE SODIUM, DIBASIC CALCIUM PHOSPHATE DIHYDRATE, FD-C RED#40 ALUMINUM LAKE, FD-C YELLOW#6 ALUMINUM LAKE, HYPROMELLOSE, MAGNESIUM STEARATE, MICROCRYSTALLINE CELLULOSE, POLYETHYLENE GLYCOL (PEG) 400, STEARIC ACID, TITANIUM DIOXIDE

🎯 Purpose 3 words ▾

PURPOSE: nasal decongestant

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49483-0223-06 · TIME 49483-0242-00 · Time →
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.