HomeNDC LookupIngredientsCaffeine › 00363-0226-12
no package photo
in the FDA label

Stay Awake Caffeine 200 mg Tablet, 100-count

by Walgreen Company · 1 BOTTLE, PLASTIC in 1 CARTON (0363-0226-12) / 100 TABLET in 1 BOTTLE, PLASTIC
NDC 00363-0226-12
🏷️ FDA NDC (as labeled) 0363-0226-12 billing pads the labeler segment with a zero
This package
Contains100-count Pack sizes2 compare ↓
Also comes in: 40 tablets 00363-0226-10
OTC Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Mar 13, 2024 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2023. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 0363-0226-12
Product NDC 0363-0226
11-digit billing NDC 00363022612
NCPDP billing unit EA — each (per item)
Application # part340
Chemical class Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH FINAL
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Dec 2023)
Route ORAL
Dosage form TABLET
Substance CAFFEINE
GCN Seq No 000033
GCN 00212
HICL code 000012
Ingredient (HICL) Caffeine
HIC1 code A
Therapeutic class — broad (HIC1) Cardiovascular System
HIC2 code A1
Therapeutic class — intermediate (HIC2) Cardiac Stimulants
HIC3 code A1B
Therapeutic class — specific (HIC3) Xanthines
AHFS code 28:20.32.00
AHFS class Respiratory And Cns Stimulants
FDB label name STAY AWAKE 200 MG TABLET
FDB brand name Stay Awake
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0363-0226-12 — a 4-4-2 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 labeler segment → 00363-0226-12. 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.

🏭 Manufacturer & labeler

LabelerWalgreen Company
FDA applicationpart340 (OTC MONOGRAPH FINAL)
Labeler code00363
Product typeHuman Otc Drug
Portfolio468 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

Label name STAY AWAKE 200 MG TABLET Ingredient Caffeine
📗 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.

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.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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: 40 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
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 mg 83059-0097-03 Shield 30 tablets FDA listed
Stay Awake 200 mgthis 00363-0226-12 Walgreen 100 tablets Discontinued
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
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
00363-0226-10 5 BLISTER PACK in 1 CARTON (0363-0226-10) / 8 TABLET in 1 BLISTER PACK 1996-11-21 Discontinued by firm
00363-0226-12 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (0363-0226-12) / 100 TABLET in 1 BOTTLE, PLASTIC 1996-11-21 Discontinued by firm

Pack size FAQ

What quantity is in NDC 00363-0226-12?
NDC 00363-0226-12 is a 100-count package — 1 bottle, plastic in 1 carton / 100 tablet in 1 bottle, plastic.
What is the difference between NDC 00363-0226-12 and NDC 00363-0226-10?
Both are Stay Awake Caffeine 200 mg Tablet — the drug itself is identical. NDC 00363-0226-12 is the 100-count package, while NDC 00363-0226-10 is the 40 tablets package.
What NDC number is used to bill for this package of Stay Awake Caffeine 200 mg Tablet?
Bill NDC 00363-0226-12 — the 11-digit billing format is 00363022612. 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 No longer marketed (per FDA listing data)
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) — Not published for this NDC No structured label is linked to this listing in DailyMed/openFDA.
Package photos — Not published for this NDC The FDA label for this product carries no photos.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
Why is there no full label on this page?
No structured FDA label (SPL) is currently linked to this NDC in DailyMed/openFDA. That can happen with older listings, certain OTC and repackaged products, and recently updated listings whose label has not yet propagated. The listing itself is still valid — this page shows everything the public feeds provide for this package.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 0363-0226-12, 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: 00363-0226-12, written without dashes as 00363022612. 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 00363-0226-12, the first segment (00363) is the labeler code FDA assigned to Walgreen Company; the middle segment (0226) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (12) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 40 tablets (00363-0226-10). 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?
Walgreen Company 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.
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.
📄 FDA label 19 words

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA.
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.