Home NDC 41163-560-08 Multi-Symptom Daytime Cold Rapid Release
Product NDC 41163-560
Requested package NDC 41163-560-08
11-digit product format 411630560
Labeler code 41163
Product ID 41163-560_a3b5b1f2-2362-4195-b6d6-2f6214bdac15
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form TABLET, COATED
Route ORAL
Labeler SUPERVALU INC.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2008-03-29
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
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 COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD MULTI-SYMPTOM DAYTIME RAPID RELEASE (ACETAMINOPHEN, PHENYLEPHRINE HCL AND DEXTROMETHORPHAN HBR) TABLET [SUPERVALU INC.] 3
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41163-560-08 41163056008 2 BLISTER PACK in 1 CARTON (41163-560-08) > 12 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2008-03-29 0000-00-00 No No Current