Cold and Flu

Product NDC
0363-6590
Requested package NDC
0363-6590-21
11-digit product format
003636590
Labeler code
0363
Product ID
0363-6590_e2af2770-215a-4da9-b422-fd970356262f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreen Company
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-03-01
Marketing end
2022-09-09
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0363-65900363-6590-21DDiscontinued 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 · 12 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…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
0363-6590-08EA - Each0363-6590e43e070d-95a0-4c15-958d-7b99e57abdfe12020-04-20
0363-6590-21EA - Each0363-659062a821d9-bb69-4b3c-86dc-72141726026912020-04-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8COLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
SORBITOLINACTIVE INGREDIENT506T60A25RCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1
WATERINACTIVE INGREDIENT059QF0KO0RCOLD AND FLU DAYTIME/MULTI-SYMPTOM/NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [WALGREEN CO.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-6590-21003636590212 BLISTER PACK in 1 CARTON (0363-6590-21) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2015-03-012022-09-09NoNoCurrent