Home NDC 56062-319-62 severe cold and flu
Product NDC 56062-319
Requested package NDC 56062-319-62
11-digit product format 560620319
Labeler code 56062
Product ID 56062-319_ecf374b1-ab84-42dd-8d0f-75ca01f96c34
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler Publix Super Markets Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-04-08
Marketing end 0000-00-00
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 2021-12-31
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 · 10 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…
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 AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, COATED [PUBLIX SUPER MARKETS INC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 56062-319-62 56062031962 12 BLISTER PACK in 1 CARTON (56062-319-62) > 2 TABLET, COATED in 1 BLISTER PACK 12 blister pack 2015-04-08 0000-00-00 No No Current