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
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 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 9 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin Low Dose ASPIRIN ARMY AND AIR FORCE EXCHANGE SERVICE e273ead7-7cbc-4fd5-a136-9d3558a35360 2026-06-24 Warnings Exact identifier application number: M013 Acetaminophen Regular Strength ACETAMINOPHEN CVS PHARMACY 5e35df92-6282-4ca6-902b-bb6bd326b487 2026-06-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Orelli Inc. 4f9f1b4e-8bbb-49b9-8e6c-263edb2c084d 2026-06-22 Warnings Exact identifier application number: M013 Pain Relief Aspirin Chewable, Low Dose ASPIRIN Rite Aid Corporation 65cdce0f-be04-43ba-8c68-bdce7983cfa1 2026-06-22 Warnings Exact identifier application number: M013 Aspirin Regimen ASPIRIN Cardinal Health 110, LLC. DBA Leader 88f425df-712d-4911-824b-94085c7190b6 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN Meijer Distribution, Inc. 3716a7d4-a555-4e54-aa0a-7b8f3e32addb 2026-06-19 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN DOLGENCORP, LLC acc94a3e-21b6-4375-9881-38cf9bab8692 2026-06-19 Warnings Exact identifier application number: M013 Aspirin Low Dose ASPIRIN L.N.K. International, Inc. 2f6ec676-3832-420e-be91-fce83f6586c8 2026-06-19 Warnings Exact identifier application number: M013 Headache Relief ACETAMINOPHEN, ASPIRIN, CAFFEINE DOLGENCORP, LLC e1e24d52-0b4d-400b-8181-e3f6ab75c4f6 2026-06-18 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Oncor Pharmaceuticals 4c396d0e-aa93-4f9e-b065-2e606f7f05cd 2026-06-17 Warnings Exact identifier application number: M013 LOW DOSE ASPIRIN ASPIRIN Famora Inc. 4dc6f119-bbde-db5f-e063-6294a90a9486 2026-06-16 Warnings Exact identifier application number: M013 Childrens Pain and Fever Relief ACETAMINOPHEN Chain Drug Marketing Association, Inc. 420a1e05-caa6-481f-bdab-a670f0220f96 2026-06-16 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN DOLGENCORP, LLC ce9f4e0d-43fb-499a-b8a2-a997a14841c4 2026-06-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN L.N.K. International, Inc. 734cc3d2-6fc5-4dcc-93ed-0b57c1f01345 2026-06-15 Warnings Exact identifier application number: M013 RIGHT REMEDIES EXTRA STRENGTH Pain Relief PM Caplet ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Strive Pharmaceuticals Inc. 2d63671d-cf7c-bbdd-e063-6294a90affef 2026-06-15 Warnings Exact identifier application number: M013 TYLENOL Extra Strength ACETAMINOPHEN Kenvue Brands LLC 59773893-09a8-47a2-943a-e9ea9da4458a 2026-06-15 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN Shield Pharmaceuticals Corp. 96eb7f9f-ff2d-4661-bbe6-1860aafe03f6 2026-06-15 Warnings Exact identifier application number: M013 Duralgina Extra Strength ACETAMINOPHEN Menper Distributors, Inc. 544e3d7e-a759-384f-e063-6294a90a5baa 2026-06-15 Warnings Exact identifier application number: M013 pain relief childrens ACETAMINOPHEN Rite Aid Corporation be2286a1-946b-4bf5-b14c-8e86da669594 2026-06-15 Warnings Exact identifier application number: M013 Aspirin 81 ASPIRIN Amerisource Bergen 4491faca-f30b-4eb0-bea9-f518f6b2f095 2026-06-15 Warnings Exact identifier application number: M013
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