Home NDC 37012-603-40 Daytime
Product NDC 37012-603
Requested package NDC 37012-603-40
11-digit product format 370120603
Labeler code 37012
Product ID 37012-603_fa20e123-9299-450e-a182-2ae5d0919c96
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Dosage form SOLUTION
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/15mL; mg/15mL; mg/15mL; mg/15mL
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 DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 BUTYLATED HYDROXYANISOLE INACTIVE INGREDIENT REK4960K2U DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 MENTHOL INACTIVE INGREDIENT L7T10EIP3A DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 SODIUM PHOSPHATE, MONOBASIC INACTIVE INGREDIENT 3980JIH2SW DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 SUCROSE INACTIVE INGREDIENT C151H8M554 DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [SHOPKO STORES OPERATING CO., LLC] 1 XANTHAN GUM INACTIVE INGREDIENT TTV12P4NEE DAYTIME SEVERE (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) SOLUTION [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 37012-603-40 37012060340 354 mL in 1 BOTTLE (37012-603-40) 354 ml 2015-09-02 0000-00-00 No No Current