FDA.reportPublic FDA data

Caffeine

Product NDC
70000-0409
11-digit product format
700000409
Labeler code
70000
Product ID
70000-0409_497945c6-ed39-4111-e063-6394a90a3cf3
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
LEADER/ Cardinal Health 110, Inc.
Application
M011
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-04-05
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
Caffeine
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
7c4d61f7-9c6a-61ac-e053-2991aa0a9533Available 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
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
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
70000-0409-1Caffeine8 in 1 BLISTER PACKTABLET86
70000-0409-1Caffeine2 in 1 CARTONTABLET26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0409-1EA - Each70000-0409f5706bc3-c51d-4bdd-b47a-5548eeeff0b712019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0409CAFFEINE TABLET [CARDINAL HEALTH]4Current NDC, Legacy NDC, 2 package rows20240124_7c4d61f7-9c6a-61ac-e053-2991aa0a9533.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
ndc (product): 70000-0409
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 TabletPSN7c4d61f7-9c6a-61ac-e053-2991aa0a95336
198520caffeine 200 MG Oral TabletSCD7c4d61f7-9c6a-61ac-e053-2991aa0a95336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0409-1700000409012 BLISTER PACK in 1 CARTON (70000-0409-1) / 8 TABLET in 1 BLISTER PACK2 blister pack2019-04-050000-00-00NoNoCurrent