Home NDC 11822-5030-8 cold relief
Product NDC 11822-5030
Requested package NDC 11822-5030-8
11-digit product format 118225030
Labeler code 11822
Product ID 11822-5030_a4f8d187-8b20-4aff-b5f7-5ad94e9e8852
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rite Aid Corporation
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-08-04
Marketing end 0000-00-00
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 GUAIFENESIN ACTIVE MOIETY 495W7451VQ COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP COLD RELIEF SEVERE, MULTI-SYMPTOM (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [RITE AID] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 11822-5030-8 11822503008 2 BLISTER PACK in 1 CARTON (11822-5030-8) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-04 0000-00-00 No No Current