FDA.reportPublic FDA data

Awake

Product NDC
36800-844
11-digit product format
368000844
Labeler code
36800
Product ID
36800-844_40e82efd-a4c9-4b38-965a-0178f507503d
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Topco Associates, LLC
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1998-04-14
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
Awake
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

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
e8961b01-d692-40e7-a52f-2d81a21f06c5Available 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
36800-844-11AwakeMaximum Strength60 in 1 BOTTLE, PLASTICTABLET, FILM COATED6010
36800-844-11AwakeMaximum Strength1 in 1 CARTONTABLET, FILM COATED110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-844AWAKE MAXIMUM STRENGTH (CAFFEINE) TABLET, FILM COATED [TOPCO ASSOCIATES, LLC]9Current NDC, Legacy NDC, 2 package rows20241004_e8961b01-d692-40e7-a52f-2d81a21f06c5.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 2 of 3 · 46 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UpSniff Smelling SaltsSMELLING SALTSShenzhen Nanjun Technology Co., Ltd3e7e4c2c-08bc-37b7-e063-6394a90a6b212025-09-10WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEKroger Company00cc94fa-23b7-4148-87a3-6691112675222025-09-04WarningsExact identifier
application number: M011
Alert Alertness AidCAFFEINEL.N.K. International, Inc.4bd13171-78a7-44bb-a6d6-94c6de1f945d2025-08-18WarningsExact identifier
application number: M011
Smelling SaltsSMELLING SALTSShenzhen Weikeduo E-commerce Co., Ltd.377fa82a-dcbe-9ab6-e063-6394a90a63842025-07-18WarningsExact identifier
application number: M011
Gluvelop SMELLING SALTSSMELLING SALTSShenzhen Nanjun Technology Co., Ltd398c26ec-5eba-1202-e063-6294a90a76c92025-07-09WarningsExact identifier
application number: M011
Stay AwakeCAFFEINECHAIN DRUG MARKETING ASSOCIATION INC5a75ff5b-78d5-4ab4-b648-f1a9511efd302025-06-07WarningsExact identifier
application number: M011
ANTYZE Smelling SaltsSMELLING SALTSShenzhen Nanjun Technology Co., Ltd33e8773c-0bea-9640-e063-6394a90ae14b2025-04-29WarningsExact identifier
application number: M011
Uplift ChewableCAFFEINECarolina Cannabis Creations LLC04a72aec-0e60-5d16-e063-6294a90a3c492025-01-15WarningsExact identifier
application number: M011
Uplift ChewableCAFFEINECarolina Cannabis Creations LLC01e352a7-24f3-d380-e063-6394a90acc5e2025-01-15WarningsExact identifier
application number: M011
Uplift ChewableCAFFEINECarolina Cannabis Creations LLC04a71dd1-19ae-d1cd-e063-6294a90a4fc02025-01-15WarningsExact identifier
application number: M011
Uplift ChewableCAFFEINECarolina Cannabis Creations LLC04a75f6a-a68e-8a0f-e063-6294a90a68c32025-01-15WarningsExact identifier
application number: M011
NoDoz Alertness AidCAFFEINE TABLET, FILM-COATEDLil' Drug Store Products, Inc.e700e809-29b5-799e-e053-2a95a90a235c2025-01-06WarningsExact identifier
application number: M011
CaffeineCAFFEINEWalgreen Companyc2c7768a-6f9d-d8fe-e053-2995a90a491c2024-12-06WarningsExact identifier
application number: M011
stay awakeCAFFEINEPUBLIX SUPER MARKETS INCaaf84add-6afd-f1d9-e053-2995a90a60752024-10-24WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEHarris Teeterb30a226a-790f-46a7-a418-623d5ee302472024-10-22WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEDISCOUNT DRUG MARTc264a28b-424b-44f0-ac80-62849dbaf0ed2024-10-16WarningsExact identifier
application number: M011
STAY AWAKECAFFEINERETAIL BUSINESS SERVICES , LLC.9f953ea7-2e15-2d67-e053-2a95a90a96ba2024-10-15WarningsExact identifier
application number: M011
VivarinCAFFEINENavajo Manufacturing Company Inc.1639b0ac-8d6a-e5fe-e063-6294a90aeead2024-10-03WarningsExact identifier
application number: M011
caffeineCAFFEINEAurohealth LLC2dbf82e7-8f3a-47fb-8045-9136f4b9ae492024-09-20WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEKROGER COMPANY167374f6-747b-cd6f-e063-6294a90a06f22024-07-01WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198520caffeine 200 MG Oral TabletPSNe8961b01-d692-40e7-a52f-2d81a21f06c510
198520caffeine 200 MG Oral TabletSCDe8961b01-d692-40e7-a52f-2d81a21f06c510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-844-11368000844111 BOTTLE, PLASTIC in 1 CARTON (36800-844-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1998-04-140000-00-00NoNoCurrent