Awake Maximum Strength Caffeine 200 mg Tablet, Film Coated, 60-count
by Topco Associates, LLC · 1 BOTTLE, PLASTIC in 1 CARTON (36800-844-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
NDC 36800-0844-11
🏷️ FDA NDC (as labeled)
36800-844-11
billing pads the product 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 →
🆔 Identity & classification
FDA NDC (as labeled)
36800-844-11
Product NDC
36800-844
11-digit billing NDC
36800084411
RxCUI
198520
UNII
3G6A5W338E
UPC
0036800414396
Application #
M011
SPL Set ID
e8961b01-d692-40e7-a52f-2d81a21f06c5
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
1998-04-14
Route
ORAL
Dosage form
TABLET, FILM COATED
Substance
CAFFEINE
Why two NDCs?
The FDA registers this code as 36800-844-11 — 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 → 36800-0844-11. 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
LabelerTopco Associates, LLC
FDA applicationM011 (OTC MONOGRAPH DRUG)
Labeler code36800
First marketedApr 1998
Product typeHuman Otc Drug
Portfolio58 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Caffeine (OTC drug) — tap one for details:
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.
💬 Questions about Caffeine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Color
white
ShapeOval
Imprint44;344
Size15 mm
ScoringScored — splits in 2
FlavorPeppermint
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 LX22YL083G
A simple sugar derived from corn or other sources. It acts as a filler to give the medicine bulk and volume, and as a sweetener to improve taste in oral medications.
-
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 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 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 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.
-
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.
8 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statescorn starch, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, 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.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 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mgthis 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 | — |
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
🏛️
1998
On the market since
Apr 1998
📍
2026
Currently FDA-listed
28 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.
🔬 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 Awake Maximum Strength (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 35%
Female · 65%
Unknown · 0%
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.
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 36800-0844-11 You're viewing this | 1 BOTTLE, PLASTIC in 1 CARTON (36800-844-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1998-04-14 | 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 36800-844-11, 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: 36800-0844-11, written without dashes as 36800084411. 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 36800-0844-11, the first segment (36800) is the labeler code FDA assigned to Topco Associates, LLC; the middle segment (0844) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (11) 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 Topco Associates, LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Topco Associates, LLC 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
📦 Storage and Handling
🧪 Active Ingredient
🧪 Inactive Ingredients
🎯 Purpose
🎯 Indications and Usage ▾
Use helps restore mental alertness or wakefulness when experiencing fatigue or drowsiness
⏱️ Dosage and Administration ▾
Directions adults and children 12 years and over: take ½ to 1 caplet not more often than every 3 to 4 hours children under 12 years: do not use
⚠️ Warnings ▾
Warnings For occasional use only Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat. Do not use for children under 12 years of age as a substitute for sleep Stop use and ask a doctor if fatigue or drowsiness persists or continues to recur.
If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
📦 Storage and Handling ▾
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
🧪 Active Ingredient ▾
Active ingredient (in each caplet) Caffeine 200 mg
🧪 Inactive Ingredients ▾
Inactive ingredients corn starch, dextrates hydrated, dibasic calcium phosphate dihydrate, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, stearic acid
🎯 Purpose ▾
Purpose Alertness aid
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 ↗
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.