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Product NDC
55315-250
11-digit product format
553150250
Labeler code
55315
Product ID
55315-250_74a766eb-e8b9-4a4f-8f3f-58cdba3b8a5a
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Freds Inc
Application
part340
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-03-01
Marketing end
2019-12-31
Substance
CAFFEINE
Active strength
200 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55315-250DDiscontinued by firm2026-10-05
excluded packagepackage55315-25055315-250-16DDiscontinued by firm2026-10-05

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55315-250-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55315-250-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55315-250-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55315-250-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55315-250-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55315-250-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55315-250-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55315-250-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55315-250-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55315-250-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55315-250-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55315-250-16557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CAFFEINEACTIVE INGREDIENT3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
CAFFEINEACTIVE MOIETY3G6A5W338ESTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933STAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48STAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MSTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BSTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSTAY AWAKE (CAFFEINE) TABLET [FREDS INC]1