Cold and Flu Relief

Product NDC
55301-660
11-digit product format
553010660
Labeler code
55301
Product ID
55301-660_217d860e-4bc6-46d8-94f9-b1b47c26f5ad
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Doxylamine succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
ARMY AND AIR FORCE EXCHANGE SERVICE
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-01
Marketing end
2023-02-10
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55301-660DDiscontinued by firm2026-10-05
excluded packagepackage55301-66055301-660-08DDiscontinued 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 packagepackage55301-660-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55301-660-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55301-660-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55301-660-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55301-660-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55301-660-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55301-660-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55301-660-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55301-660-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55301-660-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55301-660-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55301-660-08557ba5c1ecfa…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 INGREDIENT362O9ITL9DCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI2COLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
DOXYLAMINEACTIVE MOIETY95QB77JKPLCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
GELATININACTIVE INGREDIENT2G86QN327LCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND FLU RELIEF NIGHTTIME, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [ARMY AND AIR FORCE EXCHANGE SERVICE]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-660-08553010660082 BLISTER PACK in 1 CARTON (55301-660-08) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2015-03-012023-02-10NoNoCurrent