Home NDC 16103-376 Pharbetol
Product NDC 16103-376
11-digit product format 161030376
Labeler code 16103
Product ID 16103-376_008cf9fd-c19d-4e32-8386-2b6f62688e3c
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Pharbest Pharmaceuticals, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2006-01-10
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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 16103-376-08 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 16103-376-11 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 16103-376-06 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-376-08 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-376-11 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 16103-376-06 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-376-08 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-376-11 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 16103-376-06 I Inactivated by FDA bd6a592717d7…303034d00443…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 16103-376-08 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 16103-376-06 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 16103-376-11 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
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 1293942 Internal RxNorm lookup 198440 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 16103-376-06 Pharbetol 50 in 1 BOTTLE, PLASTIC TABLET 50 5 16103-376-06 Pharbetol 1 in 1 CARTON TABLET 1 5 16103-376-08 Pharbetol 100 in 1 BOTTLE, PLASTIC TABLET 100 5 16103-376-08 Pharbetol 1 in 1 CARTON TABLET 1 5 16103-376-11 Pharbetol 1000 in 1 BOTTLE, PLASTIC TABLET 1000 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16103-376 PHARBETOL (ACETAMINOPHEN) TABLET [PHARBEST PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 5 package rows 20250101_04dbd98f-c74d-43b2-8bda-74f18be7cf6c.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 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16103-376-06 16103037606 1 BOTTLE, PLASTIC in 1 CARTON (16103-376-06) / 50 TABLET in 1 BOTTLE, PLASTIC 2006-01-10 0000-00-00 No No Current 16103-376-08 16103037608 1 BOTTLE, PLASTIC in 1 CARTON (16103-376-08) / 100 TABLET in 1 BOTTLE, PLASTIC 2006-01-10 0000-00-00 No No Current 16103-376-11 16103037611 1000 TABLET in 1 BOTTLE, PLASTIC (16103-376-11) 1000 tablet 2006-01-10 0000-00-00 No No Current