Home NDC 83059-0097 Stay Awake
Product NDC 83059-0097
11-digit product format 830590097
Labeler code 83059
Product ID 83059-0097_521f2fa3-8120-45ab-e063-6294a90a73dd
Type HUMAN OTC DRUG
Nonproprietary name Caffeine
Dosage form TABLET, COATED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M011
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-18
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 Stay Awake
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAFFEINE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198520 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83059-0097-3 Stay Awake 30 in 1 BOTTLE TABLET, COATED 30 2
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.
Matched openFDA labels page 3 of 3 · 46 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83059-0097-3 83059009703 30 TABLET, COATED in 1 BOTTLE (83059-0097-3) 2026-05-18 No No Current