Home NDC 0121-0657 Acetaminophen
Product NDC 0121-0657
11-digit product format 001210657
Labeler code 0121
Product ID 0121-0657_1f8166c0-62db-10f8-e063-6394a90a86cf
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SOLUTION
Route ORAL
Labeler PAI Holdings, LLC dba PAI Pharma
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-08-01
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 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Dataset, Scope, Package NDC table Dataset Scope Package NDC excluded product product excluded package package 0121-0657-00 excluded package package 0121-0657-21 excluded package package 0121-0657-11
Additional Listing Data#
Finished product Yes
Brand name base 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 307675 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 Acetaminophen ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ACETAMINOPHEN ORAL SOLUTION (ACETAMINOPHEN) LIQUID [CARDINAL HEALTH] 2 WATER INACTIVE INGREDIENT 059QF0KO0R ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-0657 ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 15 Current NDC, Legacy NDC, 7 package rows 20240814_6ec12573-03d6-40c1-9945-d345b401e062.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 0121-0657-00 00121065700 10 TRAY in 1 CASE (0121-0657-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0657-05) 10 tray 2007-08-01 0000-00-00 No No Current 0121-0657-05 00121065705 5 mL in 1 CUP, UNIT-DOSE 5 ml Historical 0121-0657-11 00121065711 10 TRAY in 1 CASE (0121-0657-11) / 10 CUP, UNIT-DOSE in 1 TRAY / 10.15 mL in 1 CUP, UNIT-DOSE 10 tray 2007-08-01 0000-00-00 No No Current 0121-0657-21 00121065721 10 TRAY in 1 CASE (0121-0657-21) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE 10 tray 2007-08-01 0000-00-00 No No Current