Home NDC 0121-1781-00 Childrens Acetaminophen
Product NDC 0121-1781
Requested package NDC 0121-1781-00
11-digit product format 001211781
Labeler code 0121
Product ID 0121-1781_5c063866-c8c4-4be2-abad-d09d279fc99f
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-09-17
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 0121-1781 0121-1781-00 D Discontinued by firm excluded / ndc_excluded.zip 367a005e9d99…383a685ebd0f…
Additional Listing Data#
Finished product Yes
Brand name base Childrens Acetaminophen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307668 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 0121-1781-00 Childrens Acetaminophen 10 in 1 CASE SUSPENSION 10 13 0121-1781-00 Childrens Acetaminophen 10 in 1 TRAY SUSPENSION 10 13 0121-1781-05 Childrens Acetaminophen 5 mL in 1 CUP, UNIT-DOSE SUSPENSION 5 13
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Acetaminophen ACTIVE MOIETY 362O9ITL9D CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 acesulfame potassium INACTIVE INGREDIENT 23OV73Q5G9 CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Butylparaben INACTIVE INGREDIENT 3QPI1U3FV8 CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Citric Acid Monohydrate INACTIVE INGREDIENT 2968PHW8QP CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 corn syrup INACTIVE INGREDIENT 9G5L16BK6N CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 FD&C Red No. 40 INACTIVE INGREDIENT WZB9127XOA CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Magnesium Aluminum Silicate INACTIVE INGREDIENT 6M3P64V0NC CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Sodium Benzoate INACTIVE INGREDIENT OJ245FE5EU CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 sorbitol INACTIVE INGREDIENT 506T60A25R CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Water INACTIVE INGREDIENT 059QF0KO0R CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1 Xanthan Gum INACTIVE INGREDIENT TTV12P4NEE CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1781 CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN) SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA] 13 Current NDC, Legacy NDC, 3 package rows 20241010_46d9d8cd-e3db-492c-9386-7e8255beff64.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 85 · 1,687 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 0121-1781-00 00121178100 10 TRAY in 1 CASE (0121-1781-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1781-05) 10 tray 2007-09-17 0000-00-00 No No Current