Home NDC 0363-0503-07 Severe Cold
Product NDC 0363-0503
Requested package NDC 0363-0503-07
11-digit product format 003630503
Labeler code 0363
Product ID 0363-0503_86cfb365-60de-4316-bcfc-ea1513a62760
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-08-04
Marketing end 2022-08-14
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; 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 DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE COLD DAYTIME MULTI-SYMPTOM NON-DROWSY (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [WALGREEN CO.] 4
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-0503-07 00363050307 3 BLISTER PACK in 1 CARTON (0363-0503-07) > 12 TABLET, FILM COATED in 1 BLISTER PACK 3 blister pack 2005-08-04 2022-08-14 No No Current