Nite time

Product NDC
49348-741
11-digit product format
493480741
Labeler code
49348
Product ID
49348-741_668e69e4-7f73-4cc4-a1ab-9084dda5ab1e
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
McKesson (Sunmark)
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-07-18
Marketing end
2019-12-31
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
325 mg/1; mg/1; 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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-741DDiscontinued by firm2026-10-12
excluded packagepackage49348-74149348-741-02DDiscontinued by firm2026-10-12
excluded packagepackage49348-74149348-741-03DDiscontinued by firm2026-10-12
excluded packagepackage49348-74149348-741-47DDiscontinued by firm2026-10-12

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 · 48 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 packagepackage49348-741-02d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-741-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49348-741-47d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-741-02f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-741-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49348-741-47f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-741-022ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-741-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49348-741-472ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-741-02a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-741-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49348-741-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-741-02cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-741-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49348-741-47cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-741-02cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-741-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49348-741-47cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-741-02302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-741-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49348-741-47302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-741-02ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-741-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49348-741-47ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-741-020efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-741-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49348-741-470efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-741-02ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-741-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49348-741-47ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-741-02367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-741-03367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49348-741-47367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-741-02557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-741-03557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49348-741-47557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-741-02EA - Each49348-74192775e6b-f348-4747-a6f7-b0df6a8248ae12013-02-13
49348-741-03EA - Each49348-741ad6bcdbd-3472-4be5-a277-e0d3df49ff6e12013-06-04
49348-741-47EA - Each49348-741ca67f657-e4fe-432d-acff-4b8773f282b712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
DOXYLAMINEACTIVE MOIETY95QB77JKPLNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
GELATININACTIVE INGREDIENT2G86QN327LNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ENITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
SORBITANINACTIVE INGREDIENT6O92ICV9RUNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
SORBITOLINACTIVE INGREDIENT506T60A25RNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3
WATERINACTIVE INGREDIENT059QF0KO0RNITE TIME COLD AND FLU RELIEF (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]3