Home NDC 0904-7688 Anu-Med
Product NDC 0904-7688
11-digit product format 009047688
Labeler code 0904
Product ID 0904-7688_9362e9e6-430e-9d75-e053-2995a90a2820
Type HUMAN OTC DRUG
Nonproprietary name Phenylephrine Hydrochloride and Fat, Hard
Dosage form SUPPOSITORY
Route RECTAL
Labeler Major Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 1996-04-01
Marketing end 2020-07-31
Substance PHENYLEPHRINE HYDROCHLORIDE; FAT, HARD
Active strength 5 mg/1; g/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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 0904-7688-22 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 Fat, Hard ACTIVE INGREDIENT 8334LX7S21 ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Fat, Hard ACTIVE MOIETY 8334LX7S21 ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Phenylephrine ACTIVE MOIETY 1WS297W6MV ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Methylparaben INACTIVE INGREDIENT A2I8C7HI9T ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Propylparaben INACTIVE INGREDIENT Z8IX2SC1OH ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1 Starch, Corn INACTIVE INGREDIENT O8232NY3SJ ANU-MED (PHENYLEPHRINE HYDROCHLORIDE AND FAT, HARD) SUPPOSITORY [MAJOR PHARMACEUTICALS] 1