Home NDC 0121-1971 Acetaminophen
Product NDC 0121-1971
11-digit product format 001211971
Labeler code 0121
Product ID 0121-1971_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 650 mg/20.3mL
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 · 2 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 2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 0121-1971 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 0121-1971 0121-1971-00 D Discontinued by firm excluded / ndc_excluded.zip 557ba5c1ecfa…9c80585c8c6e…
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 650 mg/20.3mL
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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1971-00 Acetaminophen 10 in 1 TRAY SOLUTION 10 15 0121-1971-00 Acetaminophen 10 in 1 CASE SOLUTION 10 15 0121-1971-21 Acetaminophen 20.3 mL in 1 CUP, UNIT-DOSE SOLUTION 20.3 15
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 MOIETY 362O9ITL9D ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 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 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SORBITOL INACTIVE INGREDIENT 506T60A25R ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 2 SUCROSE INACTIVE INGREDIENT C151H8M554 ACETAMINOPHEN SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.] 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 0121-1971 ACETAMINOPHEN SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA] 15 Current NDC, Legacy NDC, 3 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 22 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TYLENOL Regular Strength ACETAMINOPHEN Kenvue Brands LLC 01f41fae-4abb-4b96-ab09-a7d3dfc286cd 2026-01-26 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN Meijer Distribution Inc ec4dbb71-b507-42a3-9b68-14d4b6621ec1 2026-01-23 Warnings Exact identifier application number: M013 Adult Low Dose Aspirin ASPIRIN NCS HealthCare of KY, LLC dba Vangard Labs 9105eff0-1c22-4298-8ee5-9fb7a1de12f1 2026-01-23 Warnings Exact identifier application number: M013 Extra Strength Pain Relief ACETAMINOPHEN Preferred Pharmaceuticals Inc. c70e3b8e-071d-4b9a-9393-ad8aa09c6b6e 2026-01-22 Warnings Exact identifier application number: M013 Tylenol Extra Strength ACETAMINOPHEN Kenvue Brands LLC 17cfa99d-abb2-4d77-9e0e-e77109fbb61a 2026-01-21 Warnings Exact identifier application number: M013 Dr Simi Extra Strength Acetaminophen 250 mg, Aspirin 250 mg, and Caffeine 65 mg ACETAMINOPHEN 250 MG, ASPIRIN 250 MG, AND CAFFEINE 65 MG Farmacias De Similares TX LLC 48ea0a2c-511b-4805-e063-6394a90a1225 2026-01-21 Warnings Exact identifier application number: M013 childrens mapap ACETAMINOPHEN Major Pharmaceuticals a1b0ccf0-cf24-4b34-b42a-aa1cc1e57f60 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH ACETAMINOPHEN ACETAMINOPHEN WALGREENS CO. 9b756e4e-6c56-43aa-a5bc-5b649440e759 2026-01-20 Warnings Exact identifier application number: M013 EXTRA STRENGTH PAIN RELIEVER PM ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE WALGREENS CO. 5a58d620-a0ec-48d7-92dd-3f3f78ec10ea 2026-01-20 Warnings Exact identifier application number: M013 equate pain reliever ACETAMINOPHEN Wal-Mart Stores Inc d4e438c6-80dd-4531-91e6-bc4ca7a8570f 2026-01-20 Warnings Exact identifier application number: M013 Unishield Extra Strength Non-Aspirin ACETAMINOPHEN Unishield ba0ec1eb-db85-6a7f-e053-2995a90aafe5 2026-01-19 Warnings Exact identifier application number: M013 pain relief ACETAMINOPHEN HyVee Inc 24acd62f-72b1-418a-b733-7e4888f3c0a3 2026-01-16 Warnings Exact identifier application number: M013 Acetaminophen Extra Strength ACETAMINOPHEN Cardinal Health 110, LLC. DBA Leader dd8b13a5-07df-4cec-92c3-1a662b1e1a56 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 7d8f8389-730d-494e-a0af-5a91a3c99e17 2026-01-16 Warnings Exact identifier application number: M013 TENSION HEADACHE RELIEF ACETAMINOPHEN AND CAFFEINE WALGREENS 54aff6a0-2778-472f-90ba-375d6bce6ee8 2026-01-16 Warnings Exact identifier application number: M013 EXTRA STRENGTH HEADACHE RELIEF ACETAMINOPHEN, ASPIRIN, CAFFEINE WALGREENS 097fbab7-3886-4e75-b037-f03adcf3859f 2026-01-16 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN WALGREENS CO. bdb09e15-8e17-4987-99d0-bab8856a2109 2026-01-16 Warnings Exact identifier application number: M013 acetaminophen ACETAMINOPHEN HF Acquisition Co LLC, DBA HealthFirst 4870ff00-f727-814d-e063-6394a90a6c8e 2026-01-15 Warnings Exact identifier application number: M013 Aspirin ASPIRIN HyVee Inc 957b13a4-4086-459f-8fa0-9708b317fabe 2026-01-15 Warnings Exact identifier application number: M013 Unisom PM Pain Nighttime Sleep Aid and Pain Reliever ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE Chattem, Inc. 451daeeb-88a9-44b1-9a2d-1ff0b0ec41cb 2026-01-14 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 0121-1971-00 00121197100 10 TRAY in 1 CASE (0121-1971-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 20.3 mL in 1 CUP, UNIT-DOSE (0121-1971-21) 10 tray 2007-08-01 0000-00-00 No No Current 0121-1971-21 00121197121 20.3 mL in 1 CUP, UNIT-DOSE 20.3 ml Historical