Home NDC 11822-0805-1 severe cold and flu relief
Product NDC 11822-0805
Requested package NDC 11822-0805-1
11-digit product format 118220805
Labeler code 11822
Product ID 11822-0805_cdaf3060-cc4d-4e6d-bef5-a1ecd68f6a2c
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rite Aid Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-07-15
Marketing end 2021-12-05
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 DOXYLAMINE SUCCINATE ACTIVE INGREDIENT V9BI9B5YI2 SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 DOXYLAMINE ACTIVE MOIETY 95QB77JKPL SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE COLD AND FLU RELIEF NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID CORPORATION] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11822-0805-1 11822080501 12 BLISTER PACK in 1 CARTON (11822-0805-1) > 2 TABLET, FILM COATED in 1 BLISTER PACK 12 blister pack 2015-07-15 2021-12-05 No No Current