Home NDC 16103-350-08 PHARBETOL
Product NDC 16103-350
Requested package NDC 16103-350-08
11-digit product format 161030350
Labeler code 16103
Product ID 16103-350_e22d20db-8648-409d-b8db-78c1dddfbf6a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg
Dosage form TABLET, COATED
Route ORAL
Labeler Pharbest Pharmaceuticals, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-03-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 · 9 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 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base PHARBETOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 1293942 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16103-350-04 PHARBETOL 1 in 1 CARTON TABLET, COATED 1 3 16103-350-04 PHARBETOL 30 in 1 BOTTLE, PLASTIC TABLET, COATED 30 3 16103-350-08 PHARBETOL 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3 16103-350-08 PHARBETOL 1 in 1 CARTON TABLET, COATED 1 3 16103-350-10 PHARBETOL 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 3 16103-350-11 PHARBETOL 1000 in 1 BOTTLE, PLASTIC TABLET, COATED 1000 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16103-350 PHARBETOL (ACETAMINOPHEN 500MG) TABLET, COATED [PHARBEST PHARMACEUTICALS, INC.] 2 Current NDC, Legacy NDC, 6 package rows 20250101_27337be9-e279-460e-903e-ae4463099599.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 83 · 1,657 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 16103-350-08 16103035008 1 BOTTLE, PLASTIC in 1 CARTON (16103-350-08) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2018-03-01 0000-00-00 No No Current