severe cold cough and flu relief

Product NDC
11822-0096
Requested package NDC
11822-0096-1
11-digit product format
118220096
Labeler code
11822
Product ID
11822-0096_127990bb-c4d9-4ff2-8012-c1129c2ec4a9
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Rite Aid Corporation
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-08-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11822-009611822-0096-1DDiscontinued 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 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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 INGREDIENT362O9ITL9DSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
ACESULFAME POTASSIUMINACTIVE INGREDIENT23OV73Q5G9SEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1SEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRSEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
SUCROSEINACTIVE INGREDIENTC151H8M554SEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28SEVERE COLD COUGH AND FLU RELIEF DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE) POWDER, FOR SOLUTION [RITE AID CORPORATION]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11822-0096-1118220096016 POWDER, FOR SOLUTION in 1 CARTON (11822-0096-1) 2015-08-050000-00-00NoNoCurrent