Nighttime

Product NDC
51672-2113
11-digit product format
516722113
Labeler code
51672
Product ID
51672-2113_d95641a2-6c74-4fdf-bdac-77773a41f921
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A. Inc.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-28
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct51672-2113DDiscontinued by firm2026-10-16
excluded packagepackage51672-211351672-2113-7DDiscontinued by firm2026-10-16

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 packagepackage51672-2113-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51672-2113-7f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51672-2113-72ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51672-2113-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51672-2113-7cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51672-2113-7cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51672-2113-7302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51672-2113-7ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51672-2113-70efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51672-2113-7ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51672-2113-7367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51672-2113-7557ba5c1ecfa…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
AcetaminophenACTIVE INGREDIENT362O9ITL9DNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
Diphenhydramine HydrochlorideACTIVE INGREDIENTTC2D6JAD40NIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
Phenylephrine HydrochlorideACTIVE INGREDIENT04JA59TNSJNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
DiphenhydramineACTIVE MOIETY8GTS82S83MNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
PhenylephrineACTIVE MOIETY1WS297W6MVNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
acesulfame potassiumINACTIVE INGREDIENT23OV73Q5G9NIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
anhydrous trisodium citrateINACTIVE INGREDIENTRS7A450LGANIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
aspartameINACTIVE INGREDIENTZ0H242BBR1NIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
D&C yellow no. 10INACTIVE INGREDIENT35SW5USQ3GNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
FD&C blue No. 1INACTIVE INGREDIENTH3R47K3TBDNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
FD&C red no. 40INACTIVE INGREDIENTWZB9127XOANIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DNIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2
sucroseINACTIVE INGREDIENTC151H8M554NIGHTTIME FLU AND SEVERE (ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [TARO PHARMACEUTICALS U.S.A. INC.]2