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 54 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NOTTS - Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE VIVUNT PHARMA LLC e6754f62-e3b2-773f-e053-2a95a90ad36a 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief ACETAMINOPHEN AAA Pharmaceutical, Inc. a891896d-c9fa-4448-915a-e6b531157d22 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN SAFEWAY d2d15e06-e9eb-3d2b-e053-2995a90a1cec 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Regular Strength ACETAMINOPHEN TopCo Associates LLC c2d33352-431c-4683-a4fa-a54437e7b8d2 2024-12-02 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN TopCo Associates LLC bdb01b3e-ad34-4003-9b9a-e83a2c0e90bb 2024-12-02 Warnings Exact identifier application number: M013 Aspirin 81mg Adult Low Dose ASPIRIN TopCare 14d010fb-c4a1-4c3d-942f-58719727bfc0 2024-12-02 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN CVS Pharmacy, Inc c4473ee6-4e01-1ec2-e053-2995a90ac513 2024-12-02 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Proficient Rx LP 9c186289-e309-45e8-8934-1d0eae0375c2 2024-12-01 Warnings Exact identifier application number: M013 Childrens Chewable Acetaminophen ACETAMINOPHEN GERI-CARE PHARMACEUTICAL CORP 22f63d62-c941-5b8f-e063-6394a90aeecd 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Acetaminophen ACETAMINOPHEN Geri-Care Pharmaceutical Corp 7a7b6318-b7d6-31b1-e053-2991aa0abf25 2024-11-28 Warnings Exact identifier application number: M013 Extra Strength Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL INGLES MARKETS, INC. 27fd288e-c07a-617f-e063-6394a90a17a4 2024-11-28 Warnings Exact identifier application number: M013 BAYER Aspirin Original, TRAVEL BASIX ASPIRIN Lil' Drug Store Products, Inc. 7f5d9ebe-8119-49a2-9380-eca18a5e5e85 2024-11-27 Warnings Exact identifier application number: M013 EXCEDRIN MIGRAINE ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE Jones Healthcare Group - Packaging Services, Inc c4168e4d-3dfc-4e51-a32e-14704cb59c66 2024-11-27 Warnings Exact identifier application number: M013 TYLENOL Extra Strength / TYLENOL Precise Cooling Pain Relief ACETAMINOPHEN, LIDOCAINE, MENTHOL Kenvue Brands LLC 2611e984-0dd5-bda1-e063-6394a90a559a 2024-11-26 Warnings Exact identifier application number: M013 First Aid Only Extra-Strength Non-Aspirin ACETAMINOPHEN Acme United Corporation 6891d57a-10a6-53de-e053-2a91aa0ac7c2 2024-11-26 Warnings Exact identifier application number: M013 Chewable Aspirin ASPIRIN MARC GLASSMAN, INC. c8314910-71ff-5a55-e053-2995a90aafc7 2024-11-26 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Marc Glassman, Inc. 7990ca49-fb30-40fe-9ac4-48e89eac9bb2 2024-11-26 Warnings Exact identifier application number: M013 Enteric Coated Aspirin Regular Strength ASPIRIN Safeway 96359eb6-62bc-4b13-960c-050af99a8c02 2024-11-26 Warnings Exact identifier application number: M013 ASPIRIN Low Dose ASPIRIN Marc Glassman, Inc. 3d519af3-9398-4439-8253-1e5d4612b8e3 2024-11-26 Warnings Exact identifier application number: M013 ACETAMINOPHEN (RED) ACETAMINOPHEN Humanwell PuraCap Pharmaceutical (Wuhan), Ltd. 06eabf4b-f8c0-439a-acf1-aa6e3075c717 2024-11-25 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