FDA.reportPublic FDA data

Stay Awake

Product NDC
63868-114
Requested package NDC
63868-114-16
11-digit product format
638680114
Labeler code
63868
Product ID
63868-114_de2c7249-8ef8-433f-bcf6-ae651bee42bc
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
CHAIN DRUG MARKETING ASSOCIATION INC
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1996-11-21
Marketing end
2027-09-30
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

Additional Listing Data#

Finished product
Yes
Brand name base
Stay Awake

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
5a75ff5b-78d5-4ab4-b648-f1a9511efd30Available 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
63868-114-16Stay Awake8 in 1 BLISTER PACKTABLET814
63868-114-16Stay Awake2 in 1 CARTONTABLET214
63868-114-40Stay Awake8 in 1 BLISTER PACKTABLET814
63868-114-40Stay Awake5 in 1 CARTONTABLET514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-114-16EA - Each63868-11447266b29-9c30-4184-af25-d63e4b9fe7e112022-09-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CAFFEINEACTIVE MOIETY3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2STAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-114STAY AWAKE (CAFFEINE) TABLET [CHAIN DRUG MARKETING ASSOCIATION INC]13Current NDC, Legacy NDC, 4 package rows20240608_5a75ff5b-78d5-4ab4-b648-f1a9511efd30.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 4 · 80 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OTTFFSS SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4e76504b-82da-e7a4-e063-6294a90a4f812026-07-30WarningsExact identifier
application number: M011
REINREUDE SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4c29c7f0-0d34-40bd-e063-6294a90a6ca72026-07-24WarningsExact identifier
application number: M011
SERYNTH SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4a4be985-7de7-4eba-e063-6394a90ac84e2026-07-21WarningsExact identifier
application number: M011
Lepnuns SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD497f5bd0-b913-706b-e063-6394a90abf302026-07-20WarningsExact identifier
application number: M011
WXMX Smelling SaltsAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49927820-1862-4792-e063-6294a90acf9e2026-07-20WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEGeiss, Destin & Dunn Inc.a4c796a8-6685-4214-bf08-10ee2735ea122026-07-09WarningsExact identifier
application number: M011
HYMYYXGS SMELLING SALTSAMMONIA 15% SMELLING SALTSWenzhou Yuyuan Pharmaceutical Co., Ltd.55edceb9-4c86-df99-e063-6294a90a79622026-07-06WarningsExact identifier
application number: M011
LAIOACDL SMELLING SALTSAMMONIA 15% SMELLING SALTSWenzhou Yuyuan Pharmaceutical Co., Ltd.55c5c8cc-f1f6-b4e4-e063-6294a90a8b8e2026-07-04WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-06-30WarningsExact identifier
application number: M011
Stay Awake Maximum StrengthCAFFEINEUnited Natural Foods, Inc. dba UNFI1357eade-f1d3-4df2-8a8a-4c318aab11412026-06-15WarningsExact identifier
application number: M011
Unikinesys SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5044b726-eeb4-0e21-e063-6394a90aeaa62026-06-14WarningsExact identifier
application number: M011
BOTASUN SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49aa685f-ced5-4da3-e063-6394a90a03c32026-06-14WarningsExact identifier
application number: M011
THITFAM SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD53f0636e-5293-b07d-e063-6294a90a0b672026-06-10WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEWal-Mart Stores Inc5f5b65a2-4db7-4c8e-a954-95611a0872172026-06-08WarningsExact identifier
application number: M011
TideFresh SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5363f670-9e77-ec37-e063-6394a90acb4a2026-06-03WarningsExact identifier
application number: M011
smelling salts SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD52c56483-e9d4-48f5-e063-6294a90a29092026-05-26WarningsExact identifier
application number: M011
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-05-21WarningsExact identifier
application number: M011
Stay AwakeCAFFEINEShield Pharmaceuticals Corp82c582ce-1360-4c4f-b9a7-a5a43cf5fd2c2026-05-18WarningsExact identifier
application number: M011
Rhinoost SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD5004eac7-3a8f-7fc9-e063-6294a90a26d52026-05-17WarningsExact identifier
application number: M011
AlertCAFFEINEDOLGENCORP, LLC9e47eed8-4d0f-4a26-b761-578fb593f0252026-05-06WarningsExact identifier
application number: M011

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198520caffeine 200 MG Oral TabletPSN5a75ff5b-78d5-4ab4-b648-f1a9511efd3014
198520caffeine 200 MG Oral TabletSCD5a75ff5b-78d5-4ab4-b648-f1a9511efd3014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-114-16638680114162 BLISTER PACK in 1 CARTON (63868-114-16) / 8 TABLET in 1 BLISTER PACK2 blister pack1996-11-212027-09-30NoNoCurrent