Home NDC 53943-320 Stay Awake
Product NDC 53943-320
11-digit product format 539430320
Labeler code 53943
Product ID 53943-320_249d8323-64c9-0a0a-e063-6394a90a1d70
Type HUMAN OTC DRUG
Nonproprietary name CAFFEINE
Dosage form TABLET
Route ORAL
Labeler DISCOUNT DRUG MART
Application M011
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-19
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 2026-12-31
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 2026-12-31 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 53943-320-02 Stay Awake 8 in 1 BLISTER PACK TABLET 8 3 53943-320-02 Stay Awake 5 in 1 CARTON TABLET 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53943-320 STAY AWAKE (CAFFEINE) TABLET [DISCOUNT DRUG MART] 3 Current NDC, Legacy NDC, 2 package rows 20241018_c264a28b-424b-44f0-ac80-62849dbaf0ed.zip
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 Units Marketing start Marketing end Sample Exclude flag Status 53943-320-02 53943032002 5 BLISTER PACK in 1 CARTON (53943-320-02) / 8 TABLET in 1 BLISTER PACK 5 blister pack 2012-01-19 0000-00-00 No No Current