FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Stay Awake
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAFFEINE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3G6A5W338E
Rxcui198520

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57243-226-21Stay Awake8 in 1 BLISTER PACKTABLET816
57243-226-21Stay Awake2 in 1 CARTONTABLET216

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSTAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57243-226STAY AWAKE (CAFFEINE) TABLET [SALADO SALES, INC.]15Current NDC, Legacy NDC, 2 package rows20250428_2bb2176f-baae-4314-af6a-9150da7017a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198520caffeine 200 MG Oral TabletPSN2bb2176f-baae-4314-af6a-9150da7017a516
198520caffeine 200 MG Oral TabletSCD2bb2176f-baae-4314-af6a-9150da7017a516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57243-226-21572430226212 BLISTER PACK in 1 CARTON (57243-226-21) / 8 TABLET in 1 BLISTER PACK2 blister pack1996-11-210000-00-00NoNoCurrent