Home NDC 0363-9527-08 Cold and Head Congestion
Product NDC 0363-9527
Requested package NDC 0363-9527-08
11-digit product format 003639527
Labeler code 0363
Product ID 0363-9527_446a9574-e7a4-469c-95ea-133cc24e3595
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Walgreen Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-08-06
Marketing end 2022-05-15
Substance ACETAMINOPHEN; GUAIFENESIN; 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 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 COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD AND HEAD CONGESTION SEVERE/DAYTIME (ACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [WALGREEN CO.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0363-9527-08 00363952708 2 BLISTER PACK in 1 CARTON (0363-9527-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-06 2022-05-15 No No Current