Active ingredient
Caffeine
79 finished FDA listings contain Caffeine as their only active ingredient; 430 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- CAFFEINE, CAFFEINE CITRATE
- Dosage forms
- Chewable Gel, Cream, Injection, Injection, Solution, Liquid, Paste, Pellet, Solution, Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Extracorporeal, Intramuscular, Intravenous, Oral, Topical
- Manufacturers / labelers
- 52
- Strengths listed
- .05 g/100ml · 1 [hp_m]/1 · 1 [hp_q]/1 · 1 g/108.27g · 100 [hp_c]/1 · 100 mg/1 · 12 [hp_c]/1 · 125 mg/ml · 20 mg/ml · 200 [hp_c]/1 · 200 mg/1 · 30 [hp_c]/1 · 500 [hp_c]/1 · 6 [hp_c]/1 · 6 g/100ml · 60 mg/3ml · 9 [hp_x]/29.5ml
- Brand names in FDA listings
- Alert, Alert Aid, Alert Alertness Aid, Awake Maximum Strength, Caffeine 1508, Caffeine Citrate Oral Solution, Diurex Ultimate, Diurex Ultra, Earthmed Uplift Chewable Cherry, Earthmed Uplift Chewable Orange, Earthmed Uplift Chewable Strawberry, Earthmed Uplift Chewable Watermelon, Feelshion 6% Caffeine 1% Retinol Eye Cream, Gowilove Botin Conditioner, Gowilove Botin Sham Poo, Jet Alert Double Strength, Jet Alert Regular Strength, Nodoz Alertness Aid, Stay Awake, Stay Awake Maximum Strength, Topcare Stay Awake Maximum Strength, Uplift Chewable, Vivarin
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1886
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 020793 | HIKMA | 1999-09-21 | 1 |
| ANDA 077304 | EXELA PHARMA | 2006-09-21 | 1 |
| ANDA 077233 | EXELA PHARMA SCIENCE | 2006-09-21 | 1 |
| ANDA 077997 | FRESENIUS KABI USA | 2007-07-20 | 2 |
| ANDA 078002 | FRESENIUS KABI USA | 2008-01-31 | 1 |
| ANDA 090357 | SUN PHARM | 2009-09-30 | 1 |
| ANDA 090077 | SUN PHARM | 2009-09-30 | 1 |
| ANDA 090827 | SAGENT PHARMS | 2012-08-29 | 1 |
| ANDA 091102 | SAGENT PHARMS | 2012-08-29 | 1 |
| ANDA 205013 | EUGIA PHARMA | 2015-09-22 | 1 |
| ANDA 207400 | MICRO LABS | 2017-12-14 | 2 |
| ANDA 213202 | MICRO LABS | 2019-12-16 | 2 |
Official labeling on DailyMed
- STAY AWAKE (CAFFEINE) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI] · version 18 · 2026-08-24
- CAFFEINE CITRATE SOLUTION [SAGENT PHARMACEUTICALS] · version 10 · 2026-08-10
- CAFFEINE CITRATE (CAFFEINE CITRATE) SOLUTION [MICRO LABS LIMITED] · version 5 · 2026-08-03
- CAFFEINE CITRATE (CAFFEINE CITRATE) INJECTION, SOLUTION [MICRO LABS LIMITED] · version 9 · 2026-08-03
- STAY AWAKE (CAFFEINE) TABLET [GEISS, DESTIN & DUNN INC.] · version 9 · 2026-07-20
- STAY AWAKE (CAFFEINE) TABLET [WAL-MART STORES INC] · version 17 · 2026-06-18
- STAY AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [UNITED NATURAL FOODS, INC. DBA UNFI] · version 18 · 2026-06-18
- DIUREX ULTIMATE (CAFFEINE) TABLET, FILM COATED [KOBAYASHI HEALTHCARE INTERNATIONAL, INC.] · version 13 · 2026-06-10
- STAY AWAKE (CAFFEINE) TABLET, COATED [SHIELD PHARMACEUTICALS CORP] · version 2 · 2026-05-20
- STAY AWAKE (CAFFEINE) TABLET [STRATEGIC SOURCING SERVICES LLC] · version 6 · 2026-05-11
- VIVARIN (CAFFEINE) TABLET [VESPYR BRANDS LLC] · version 5 · 2026-05-11
- ALERT (CAFFEINE) TABLET [DOLGENCORP, LLC] · version 22 · 2026-05-11
Showing the 12 most recent of 63 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.