Walgreens Severe Cold Multi-Symptom For Adults

Product NDC
0363-8591
11-digit product format
003638591
Labeler code
0363
Product ID
0363-8591_f4efb560-5ae6-4050-b06e-79f784ce7960
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
WALGREEN CO.
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-05-27
Marketing end
2022-06-22
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325 mg/15mL; mg/15mL; mg/15mL; mg/15mL
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 productproduct0363-8591DDiscontinued by firm2026-10-02
excluded packagepackage0363-85910363-8591-20DDiscontinued by firm2026-10-02

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 packagepackage0363-8591-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-8591-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-8591-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-8591-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-8591-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-8591-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-8591-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-8591-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-8591-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-8591-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-8591-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-8591-20557ba5c1ecfa…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 INGREDIENT362O9ITL9DWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYHWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
GUAIFENESINACTIVE INGREDIENT495W7451VQWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTSWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
GUAIFENESINACTIVE MOIETY495W7451VQWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MVWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
MENTHOLINACTIVE INGREDIENTL7T10EIP3AWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3WALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
SORBITOLINACTIVE INGREDIENT506T60A25RWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4WALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2
WATERINACTIVE INGREDIENT059QF0KO0RWALGREENS SEVERE COLD MULTI-SYMPTOM FOR ADULTS (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [WALGREEN CO.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-8591-20003638591201 BOTTLE in 1 CARTON (0363-8591-20) > 240 mL in 1 BOTTLE1 bottle2015-05-272022-06-22NoNoCurrent