Home NDC 57243-226 Stay Awake
Product NDC 57243-226
11-digit product format 572430226
Labeler code 57243
Product ID 57243-226_51685540-d721-4c16-a810-66ff7151b2c6
Type HUMAN OTC DRUG
Nonproprietary name Caffeine
Dosage form TABLET
Route ORAL
Labeler Salado Sales, Inc.
Application M011
Marketing category OTC MONOGRAPH DRUG
Marketing start 1996-11-21
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 57243-226-21 Stay Awake 8 in 1 BLISTER PACK TABLET 8 16 57243-226-21 Stay Awake 2 in 1 CARTON TABLET 2 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CAFFEINE ACTIVE INGREDIENT 3G6A5W338E STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 CAFFEINE ACTIVE MOIETY 3G6A5W338E STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS INACTIVE INGREDIENT L11K75P92J STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57243-226 STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250428_2bb2176f-baae-4314-af6a-9150da7017a5.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 57243-226-21 57243022621 2 BLISTER PACK in 1 CARTON (57243-226-21) / 8 TABLET in 1 BLISTER PACK 2 blister pack 1996-11-21 0000-00-00 No No Current