Home NDC 55315-099 Day Time Sinus
Product NDC 55315-099
11-digit product format 553150099
Labeler code 55315
Product ID 55315-099_26e63f3d-5446-4118-96aa-5d674600b94f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Freds Inc
Application part341
Marketing category OTC MONOGRAPH FINAL
Marketing start 2012-08-15
Marketing end 2024-01-12
Substance ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325 mg/1; mg/1
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 · 24 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 package package 55315-099-16 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 package package 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 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 55315-099-16 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 PHENYLEPHRINE HYDROCHLORIDE ACTIVE INGREDIENT 04JA59TNSJ DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 PHENYLEPHRINE ACTIVE MOIETY 1WS297W6MV DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 SORBITAN INACTIVE INGREDIENT 6O92ICV9RU DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DAY TIME SINUS PAIN RELIEVER, NASAL DECONGESTANT (ACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [FREDS INC] 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55315-099-16 55315009916 2 BLISTER PACK in 1 CARTON (55315-099-16) > 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2012-08-15 2024-01-12 No No Current