Home NDC 55312-317-08 Flu Relief Therapy
Product NDC 55312-317
Requested package NDC 55312-317-08
11-digit product format 553120317
Labeler code 55312
Product ID 55312-317_8b4ccd39-0f6a-4e5f-991a-8c5a65a268ee
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Diphenhydramine HCl, Phenylephrine HCl
Dosage form LIQUID
Route ORAL
Labeler Western Family Foods, Inc.
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2015-08-31
Marketing end 2021-12-31
Substance ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength 650 mg/30mL; mg/30mL; mg/30mL
NDC exclude flag No
Listing certified through 0000-00-00
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 FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 DIPHENHYDRAMINE HYDROCHLORIDE ACTIVE INGREDIENT TC2D6JAD40 FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 DIPHENHYDRAMINE ACTIVE MOIETY 8GTS82S83M FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 ACESULFAME POTASSIUM INACTIVE INGREDIENT 23OV73Q5G9 FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 MALTITOL INACTIVE INGREDIENT D65DG142WK FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 TRISODIUM CITRATE DIHYDRATE INACTIVE INGREDIENT B22547B95K FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R FLU RELIEF THERAPY NIGHTTIME (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) LIQUID [WESTERN FAMILY FOODS, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55312-317-08 55312031708 245 mL in 1 BOTTLE, PLASTIC (55312-317-08) 245 ml 2015-08-31 2021-12-31 No No Current