FDA.reportPublic FDA data

Alertness Aid

Product NDC
68016-680
11-digit product format
680160680
Labeler code
68016
Product ID
68016-680_005de878-e48a-400e-903c-24f4c42d5c91
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Chain Drug Consortium
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-11-21
Marketing end
2026-07-31
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
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-680DDiscontinued by firm2026-09-14
excluded packagepackage68016-68068016-680-16DDiscontinued by firm2026-09-14
excluded packagepackage68016-68068016-680-40DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
68016-680-16Alertness Aid8 in 1 BLISTER PACKTABLET814
68016-680-16Alertness Aid2 in 1 CARTONTABLET214
68016-680-40Alertness Aid5 in 1 CARTONTABLET514
68016-680-40Alertness Aid8 in 1 BLISTER PACKTABLET814

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338EALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
CAFFEINEACTIVE MOIETY3G6A5W338EALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2ALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-680ALERTNESS AID (CAFFEINE) TABLET [CHAIN DRUG CONSORTIUM]13Current NDC, Legacy NDC, 4 package rows20250512_0dbca3a0-cb7f-4339-a35d-92b84e39066b.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 1 of 3 · 55 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay AwakeCAFFEINEUnited Natural Foods, Inc. dba UNFI15e4d040-ed21-46e7-98c6-56267f388f572026-08-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEGeiss, Destin & Dunn Inc.a4c796a8-6685-4214-bf08-10ee2735ea122026-07-09WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEUnited Natural Foods, Inc. dba UNFI1357eade-f1d3-4df2-8a8a-4c318aab11412026-06-15WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEWal-Mart Stores Inc5f5b65a2-4db7-4c8e-a954-95611a0872172026-06-08WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEShield Pharmaceuticals Corp82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c2026-05-18WarningsExact identifier
application number: M011
AlertCAFFEINEDOLGENCORP, LLC9e47eed8-4d0f-4a26-b761-578fb593f0252026-05-06WarningsExact identifier
application number: M011
stay awakeCAFFEINERite Aid Corporatione33e353c-3af4-4e91-bd76-fa09860fee432026-05-06WarningsExact identifier
application number: M011
VIVARINCAFFEINEVespyr Brands LLC4537a56b-e875-4961-9fff-3f778746f1262026-05-01WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEStrategic Sourcing Services LLC49f408a8-b182-4172-84aa-390bff31d5d52026-05-01WarningsExact identifier
application number: M011
Stay AwakeCAFFEINESalado Sales, Inc.2bb2176f-baae-4314-af6a-9150da7017a52026-04-29WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Weitapai E-commerce Co., Ltd.4f699c20-63ff-35c5-e063-6294a90a018b2026-04-14WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSGuangzhou Zhenxiang E-commerce Co., Ltd.4f11f1ce-389d-2523-e063-6294a90aba502026-04-09WarningsExact identifier
application number: M011
ALLBIZR IRON SHOGUN SMELLING SALTSAMMONIAHong Kong Xile International Trading Limited4eba5d6e-dc7b-5d69-e063-6294a90a7b4a2026-04-05WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEBetter Living Brands, LLC976780f9-228c-44cb-b1f4-8027280fc7cb2026-03-11WarningsExact identifier
application number: M011
CaffeineCAFFEINECVS Pharmacy, Inc.6d9b3926-7198-5e00-e053-2a91aa0a95802026-02-24WarningsExact identifier
application number: M011
CaffeineCAFFEINELEADER/ Cardinal Health 110, Inc.7c4d61f7-9c6a-61ac-e053-2991aa0a95332026-01-28WarningsExact identifier
application number: M011
Awake Maximum StrengthCAFFEINEBetter Living Brands, LLCce4da457-805f-4d2a-8667-6516eea852212026-01-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEARMY AND AIR FORCE EXCHANGE SERVICE44d60bfb-4320-4f5b-8a22-9a984805ddaf2026-01-06WarningsExact identifier
application number: M011
SYBORG SALTS Smelling SaltAMMONIUM CARBONATE AND SODIUM CARBONATEDirect Outlet Supplier LLCb9a9d589-00ef-4464-9a50-985d0d71664f2026-01-06WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEVALU MERCHANDISERS COMPANYb2ae7941-5711-4046-b715-bc77cc04becb2025-12-11WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198520caffeine 200 MG Oral TabletPSN0dbca3a0-cb7f-4339-a35d-92b84e39066b14
198520caffeine 200 MG Oral TabletSCD0dbca3a0-cb7f-4339-a35d-92b84e39066b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-680-16680160680162 BLISTER PACK in 1 CARTON (68016-680-16) > 8 TABLET in 1 BLISTER PACK2 blister pack1996-11-210000-00-00NoNoCurrent
68016-680-40680160680405 BLISTER PACK in 1 CARTON (68016-680-40) / 8 TABLET in 1 BLISTER PACK5 blister pack1996-11-212026-07-31NoNoCurrent