Drowz Away

Product NDC
41520-252
11-digit product format
415200252
Labeler code
41520
Product ID
41520-252_10455c03-d970-4450-ac6f-28a0ef06f580
Type
HUMAN OTC DRUG
Nonproprietary name
Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part340
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-08-31
Marketing end
2020-08-31
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 productproduct41520-252DDiscontinued by firm2026-10-15
excluded packagepackage41520-25241520-252-16DDiscontinued by firm2026-10-15

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 packagepackage41520-252-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41520-252-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41520-252-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41520-252-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41520-252-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41520-252-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41520-252-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41520-252-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41520-252-160efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41520-252-16ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41520-252-16367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41520-252-16557ba5c1ecfa…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 INGREDIENT3G6A5W338EDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CAFFEINEACTIVE MOIETY3G6A5W338EDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDROWZ AWAY MAXIMUM STRENGTH (CAFFEINE) TABLET [CARE ONE (AMERICAN SALES COMPANY)]1