Home NDC 55301-560-08 Cold Multi-Symptom
Product NDC 55301-560
Requested package NDC 55301-560-08
11-digit product format 553010560
Labeler code 55301
Product ID 55301-560_c5c9d9f9-dc60-4a7a-a998-b86cab252726
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form TABLET
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
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
NDC exclude flag No
Listing certified through 2022-12-31
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 NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD MULTI-SYMPTOM NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) TABLET [ARMY AND AIR FORCE EXCHANGE SERVICE] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55301-560-08 55301056008 2 BLISTER PACK in 1 CARTON (55301-560-08) > 12 TABLET in 1 BLISTER PACK 2 blister pack 2008-03-29 0000-00-00 No No Current