FDA.reportPublic FDA data

Stay Awake

Product NDC
50804-262
11-digit product format
508040262
Labeler code
50804
Product ID
50804-262_c53e2f19-7447-4370-b9dc-8c261d087f96
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Geiss, Destin & Dunn Inc.
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
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
IngredientStrength
CAFFEINE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198520Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4c796a8-6685-4214-bf08-10ee2735ea12Available on FDA.report

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
50804-262-10Stay Awake5 in 1 CARTONTABLET58
50804-262-10Stay Awake8 in 1 BLISTER PACKTABLET88
50804-262-21Stay Awake8 in 1 BLISTER PACKTABLET88
50804-262-21Stay Awake2 in 1 CARTONTABLET28

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50804-262-10EA - Each50804-2621a0b51a3-036e-442e-8dd6-07b1c336ed2412025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50804-262STAY AWAKE (CAFFEINE) TABLET [GEISS, DESTIN & DUNN INC.]7Current NDC, Legacy NDC, 4 package rows20240709_a4c796a8-6685-4214-bf08-10ee2735ea12.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AwakeCAFFEINEAAA Pharmaceutical, Inc.14967dc9-d223-d954-e063-6394a90aa6762024-06-13WarningsExact identifier
application number: M011
JET ALERT Regular StrengthCAFFEINEBell Pharmaceuticals, Inccd7366f9-6ee9-4f1d-bfd2-3ce067f59b2d2023-12-15WarningsExact identifier
application number: M011
Sleep AidDIPHENHYDRAMINE HCLAllegiant Health9746911a-36bc-45eb-adfd-e96439d7a8652021-08-30WarningsExact identifier
application number: M011
Topcare Stay Awake Maximum StrengthCAFFEINETopCo Associates, LLC2223cf52-c172-462d-aacc-b069849b74412021-04-28WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEAllegiant Health959b50a1-3037-4f94-8bc5-6515018150922019-01-08WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEMarc Glassman, Inc.fda5b0a8-2c85-4a8b-97ab-777682c816e22016-12-21WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198520caffeine 200 MG Oral TabletPSNa4c796a8-6685-4214-bf08-10ee2735ea128
198520caffeine 200 MG Oral TabletSCDa4c796a8-6685-4214-bf08-10ee2735ea128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50804-262-10508040262105 BLISTER PACK in 1 CARTON (50804-262-10) / 8 TABLET in 1 BLISTER PACK5 blister pack2020-07-010000-00-00NoNoCurrent
50804-262-21508040262212 BLISTER PACK in 1 CARTON (50804-262-21) / 8 TABLET in 1 BLISTER PACK2 blister pack2020-07-010000-00-00NoNoCurrent