Home NDC 63941-503 Multi-Symptom Cold
Product NDC 63941-503
11-digit product format 639410503
Labeler code 63941
Product ID 63941-503_4dac7dea-2fbd-4826-a808-89bd627780dc
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Valu Merchandisers Company
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 · 28 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63941-503-08 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63941-503-08 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63941-503-08 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 63941-503-08 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 63941-503-08 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 63941-503-08 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 63941-503-08 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 63941-503-08 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 63941-503-08 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 63941-503-08 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 63941-503-08 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 63941-503-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 63941-503-08 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 63941-503-08 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 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 DEXTROMETHORPHAN HYDROBROMIDE ACTIVE INGREDIENT 9D2RTI9KYH MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 DEXTROMETHORPHAN ACTIVE MOIETY 7355X3ROTS MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 GUAIFENESIN ACTIVE MOIETY 495W7451VQ MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 TALC INACTIVE INGREDIENT 7SEV7J4R1U MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALUE MERCHANDISERS COMPANY, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-503 MULTI-SYMPTOM COLD SEVERE, NON-DROWSY, DAYTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY] 11 Legacy NDC 20231221_67d9bd9c-918e-4ed1-8076-7f86b7c2730e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63941-503-08 63941050308 2 BLISTER PACK in 1 CARTON (63941-503-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-04 0000-00-00 No No Current