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Stay Awake Caffeine 200 mg Tablet, Coated, 30-count — NDC 83059-0097-03 package photo

Stay Awake Caffeine 200 mg Tablet, Coated, 30-count

by Shield Pharmaceuticals Corp · 30 TABLET, COATED in 1 BOTTLE (83059-0097-3)
NDC 83059-0097-03
🏷️ FDA NDC (as labeled) 83059-0097-3 billing pads the package segment with a zero
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) 83059-0097-3
Product NDC 83059-0097
11-digit billing NDC 83059009703
RxCUI 198520
UNII 3G6A5W338E
Application # M011
SPL Set ID 82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c
Established class (EPC) Central Nervous System Stimulant; Methylxanthine
Physiologic effect Central Nervous System Stimulation
Chemical class Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-05-18
Route ORAL
Dosage form TABLET, COATED
Substance CAFFEINE
Why two NDCs? The FDA registers this code as 83059-0097-3 — a 5-4-1 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 package segment → 83059-0097-03. 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 Central Nervous System Stimulant class.

Pharmacologic class Central Nervous System Stimulant, Methylxanthine
Drug family (ATC) Tests for gastric secretion, Other dermatologicals, Xanthine derivatives
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

LabelerShield Pharmaceuticals Corp
FDA applicationM011 (OTC MONOGRAPH DRUG)
Labeler code83059
First marketedMay 2026
Product typeHuman Otc Drug
Portfolio101 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

📗 Our plain-language guide HelloPharmacist
  • Caffeine citrate is a prescription medicine given in the hospital to premature babies who have apnea of prematurity — that means they sometimes stop breathing for short periods, wh...
  • What exactly is caffeine citrate used for in babies, and is it safe?
  • The medical team will be monitoring your baby closely, but it helps to know the signs to watch for. The most serious concern is necrotizing enterocolitis (NEC) — a severe intestina...
  • What side effects should I watch for in my premature baby on caffeine citrate?
📖 Read our full Caffeine guide →
1
Nutrient depletion considerations

Caffeine (OTC drug) may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Caffeine (OTC drug) nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
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 yellow
ShapeCapsule
ImprintET38
Size11 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 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 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 J2B2A4N98G
    Lactose is a natural sugar derived from milk. In medications, it serves as a filler and binder to add bulk and help hold tablet or capsule ingredients together during manufacturing.
  • 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 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your 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 H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • UNII 8I089SAH3T
    A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.
  • 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 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • 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.

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

The official label also statescolloidal silicon dioxide*, crosscarmellose sodium*, D&C yellow # 10*, FD&C yellow # 6, hypermellose*, lactose*, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide* *contains one or more of these ingredients

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.
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
Alert Aid 200 mg 46122-0457-73 Amerisource 16 tablets $0.085 — Availability likely —
Caffeine 200 mg 70000-0409-01 LEADER/ 16 tablets $0.085 — Availability likely —
Stay Awake 200 mg 70677-1126-01 Strategic 16 tablets $0.085 — Availability likely —
Stay Awake 200 mg 83324-0074-16 Chain 16 tablets $0.085 — Availability likely —
Awake Maximum Strength 200 mg 00363-3440-11 Walgreen 60 tablets — — FDA listed —
Caffeine 200 mg 00363-5009-01 Walgreen 100 tablets — — FDA listed —
stay awake 200 mg 11822-2260-02 Rite 100 tablets — — FDA listed —
JET ALERT Double Strength 200 mg 15579-0200-16 Bell 90 tablets — — FDA listed —
Stay Awake Maximum Strength 200 mg 21130-0226-10 Better 40 tablets — — FDA listed —
Awake Maximum Strength 200 mg 21130-0944-11 Better 60 tablets — — FDA listed —
Stay Awake 200 mg 30142-0284-40 KROGER 40 tablets — — FDA listed —
Stay Awake 200 mg 30142-0726-10 Kroger 40 tablets — — FDA listed —
Awake Maximum Strength 200 mg 36800-0844-11 Topco 60 tablets — — FDA listed —
Stay Awake 200 mg 41163-0226-10 United 40 tablets — — FDA listed —
Stay Awake Maximum Strength 200 mg 41163-0434-11 United 60 tablets — — FDA listed —
Stay Awake 200 mg 49035-0226-31 Wal-Mart 80 tablets — — FDA listed —
Alert 200 mg 49483-0343-44 Time 40 tablets — — FDA listed —
Stay Awake 200 mg 50804-0262-10 Geiss, 40 tablets — — FDA listed —
Alert Alertness Aid 200 mg 50844-0226-12 L.N.K. 100 tablets — — FDA listed —
Stay Awake 200 mg 53943-0320-02 DISCOUNT 40 tablets — — FDA listed —
Stay Awake 200 mg 55301-0226-10 ARMY 40 tablets — — FDA listed —
Alert 200 mg 55910-0226-21 DOLGENCORP, 16 tablets — — FDA listed —
stay awake 200 mg 56062-0030-01 PUBLIX 16 tablets — — FDA listed —
Stay Awake 200 mg 57243-0226-21 Salado 16 tablets — — FDA listed —
Stay Awake 200 mg 57344-0220-02 AAA 40 tablets — — FDA listed —
caffeine 200 mg 58602-0747-47 Aurohealth 40 tablets — — FDA listed —
Stay Awake 200 mg 63868-0114-16 CHAIN 16 tablets — — FDA listed —
Stay Awake 200 mg 63941-0020-01 VALU 16 tablets — — FDA listed —
NoDoz Alertness Aid 200 mg 66715-9899-03 Lil' 2 tablets — — FDA listed —
Stay Awake 200 mg 67091-0117-16 WinCo 16 tablets — — FDA listed —
Vivarin 200 mg 67751-0226-04 Navajo 4 tablets — — FDA listed —
Alertness Aid 200 mg 68016-0680-16 Chain 16 tablets — — Discontinued —
Stay Awake 200 mg 68998-0076-84 Marc 8 tablets — — FDA listed —
Stay Awake 200 mg 69168-0076-40 Allegiant 40 tablets — — FDA listed —
Caffeine 200 mg 69842-0500-11 CVS 60 tablets — — FDA listed —
Caffeine 200 mg 69842-0509-10 CVS 40 tablets — — FDA listed —
Vivarin 200 mg 71179-0018-16 Vespyr 16 tablets — — FDA listed —
Stay Awake 200 mg 72036-0020-02 Harris 40 tablets — — FDA listed —
Stay Awake 200 mg 72476-0102-01 RETAIL 16 tablets — — FDA listed —
Topcare Stay Awake Maximum Strength 200 mg 76162-0002-58 TopCo 8 tablets — — FDA listed —
Stay Awake 200 mg 83059-0008-01 Shield 15 tablets — — Discontinued —
Stay Awake 200 mgthis 83059-0097-03 Shield 30 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

🏛️
2026
On the market since
May 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔒
·
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.

🔬 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 stay awake (this brand).

Top reported reactions

Toxicity To Various Agents1,373
Fatigue1,276
Pain1,147
Arthralgia1,079
Alopecia1,077
Vomiting1,061
Dyspnoea1,054

Age at onset

Neonate83
Infant27
Child16
Adolescent33
Adult937
Elderly167

Reporter sex

7,501 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization3,081
Life-threatening1,960
Disabling1,765
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,474 0
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
83059-0097-03 You're viewing this 30 TABLET, COATED in 1 BOTTLE (83059-0097-3) 2026-05-18 Active

🧭 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 FDA registers it as 83059-0097-3, 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: 83059-0097-03, written without dashes as 83059009703. 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 83059-0097-03, the first segment (83059) is the labeler code FDA assigned to Shield Pharmaceuticals Corp; the middle segment (0097) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) 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 Shield Pharmaceuticals Corp. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shield Pharmaceuticals Corp 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 12 words ▾

Uses helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness

⏱️ Dosage and Administration 20 words ▾

Directions adults and children 12 years and over: take 1 tablet not more often than every 3 to 4 hours

⚠️ Warnings 81 words ▾

Warnings Do not use as a substitute for sleep. This product is intended for occasional use only. in children under 12 years of age When using this product limit the use of caffeine-containing medications, foods, or beverages because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat. The recommended dose of this product contains about as much caffeine as a cup of coffee.

Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.

🧪 Active Ingredient 8 words ▾

Active ingredient (in each tablet) Caffeine 200 mg

🧪 Inactive Ingredients 41 words ▾

Inactive ingredients colloidal silicon dioxide*, crosscarmellose sodium*, D&C yellow # 10*, FD&C yellow # 6, hypermellose*, lactose*, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, stearic acid, talc, titanium dioxide* *contains one or more of these ingredients

🎯 Purpose 3 words ▾

Purpose Alertness aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
83059-0098-00 · Shield →
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.