Awake
- Product NDC
- 0363-3440
- 11-digit product format
- 003633440
- Labeler code
- 0363
- Product ID
- 0363-3440_59e8b800-5974-4d96-b49b-16bc5964adc2
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Caffeine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Walgreen Company
- Application
- M011
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1998-04-14
- Substance
- CAFFEINE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Awake
- Brand name suffix
- Maximum Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CAFFEINE | 200 mg/1 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0363-3440-11 | AwakeMaximum Strength | 60 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 60 | 20 | |
| 0363-3440-11 | AwakeMaximum Strength | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 20 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0363-3440-11 | EA - Each | 0363-3440 | 026b3dab-e574-467a-a5fa-42ad2f755315 | 1 | 2022-06-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Stay Awake | CAFFEINE | AAA Pharmaceutical, Inc. | 14967dc9-d223-d954-e063-6394a90aa676 | 2024-06-13 | Warnings | M011 |
| JET ALERT Regular Strength | CAFFEINE | Bell Pharmaceuticals, Inc | cd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d | 2023-12-15 | Warnings | M011 |
| Sleep Aid | DIPHENHYDRAMINE HCL | Allegiant Health | 9746911a-36bc-45eb-adfd-e96439d7a865 | 2021-08-30 | Warnings | M011 |
| Topcare Stay Awake Maximum Strength | CAFFEINE | TopCo Associates, LLC | 2223cf52-c172-462d-aacc-b069849b7441 | 2021-04-28 | Warnings | M011 |
| Stay Awake | CAFFEINE | Allegiant Health | 959b50a1-3037-4f94-8bc5-651501815092 | 2019-01-08 | Warnings | M011 |
| Stay Awake | CAFFEINE | Marc Glassman, Inc. | fda5b0a8-2c85-4a8b-97ab-777682c816e2 | 2016-12-21 | Warnings | M011 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198520 | caffeine 200 MG Oral Tablet | PSN | 899acc4f-4d50-41d0-bcf2-9937d58aa923 | 20 |
| 198520 | caffeine 200 MG Oral Tablet | SCD | 899acc4f-4d50-41d0-bcf2-9937d58aa923 | 20 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0363-3440-11 | 00363344011 | 1 BOTTLE, PLASTIC in 1 CARTON (0363-3440-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | 1998-04-14 | 0000-00-00 | No | No | Current |