Home NDC 63941-527 Severe Sinus Congestion and Pain
Product NDC 63941-527
11-digit product format 639410527
Labeler code 63941
Product ID 63941-527_33305b4a-b4cf-480b-be5d-0fed90fddb91
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Guaifenesin and Phenylephrine HCl
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Valu Merchandisers Company
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2005-08-06
Marketing end 0000-00-00
Substance ACETAMINOPHEN; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1; mg/1
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 63941-527 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 63941-527 63941-527-08 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 GUAIFENESIN ACTIVE INGREDIENT 495W7451VQ SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 GUAIFENESIN ACTIVE MOIETY 495W7451VQ SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 MALTODEXTRIN INACTIVE INGREDIENT 7CVR7L4A2D SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 SUCRALOSE INACTIVE INGREDIENT 96K6UQ3ZD4 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, COATED [VALUE MERCHANDISERS COMPANY, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63941-527 SEVERE SINUS CONGESTION AND PAIN NON-DROWSY, DAYTIME (ACETAMINOPHEN, GUAIFENESIN AND PHENYLEPHRINE HCL) TABLET, FILM COATED [VALU MERCHANDISERS COMPANY] 16 Legacy NDC 20240131_6bb511c3-1b31-4436-9fdb-6b74e0a46096.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63941-527-08 63941052708 2 BLISTER PACK in 1 CARTON (63941-527-08) > 12 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2005-08-06 0000-00-00 No No Current