Home NDC 37012-548-62 Day Time
Product NDC 37012-548
Requested package NDC 37012-548-62
11-digit product format 370120548
Labeler code 37012
Product ID 37012-548_2f22befa-5803-488d-8818-554eb7e9ce41
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Shopko Stores Operating Co., LLC
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-09-02
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 2020-12-31
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 · 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 DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DAY TIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [SHOPKO STORES OPERATING CO., LLC] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 37012-548-62 37012054862 12 BLISTER PACK in 1 CARTON (37012-548-62) > 2 TABLET, FILM COATED in 1 BLISTER PACK 12 blister pack 2015-09-02 0000-00-00 No No Current