Home NDC 69729-055 SEDAL3X
Product NDC 69729-055
11-digit product format 697290055
Labeler code 69729
Product ID 69729-055_5c3f72a5-db41-939d-e063-6394a90a4166
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Aspirin, Caffeine
Dosage form TABLET
Route ORAL
Labeler OPMX LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-07
Substance ACETAMINOPHEN; CAFFEINE; ASPIRIN
Active strength 250; 65; 250 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69729-055-40 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69729-055-40 1332a3947898…d4bfe170f9cd…
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 SEDAL3X
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 250 mg/1 CAFFEINE 65 mg/1 ASPIRIN 250 mg/1
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 69729-055-40 SEDAL3X 40 in 1 BOTTLE TABLET 40 3 69729-055-40 SEDAL3X 1 in 1 CARTON TABLET 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69729-055 SEDAL3X (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [OPMX LLC] 3 Current NDC, Legacy NDC, 2 package rows 20240606_e9089f8b-3d23-5c81-e053-2995a90a4202.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 31 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL Walgreen Company b4d8860b-d72f-4789-945e-1c6420a8efab 2025-12-02 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY f7b304d8-e37c-4ac6-b4a2-1797b92cb832 2025-12-01 Warnings Exact identifier application number: M013 Dye FreeInfants Pain and Fever ACETAMINOPHEN WALGREEN COMPANY 1a304570-88b6-4c16-a8b4-c064bfa5d95a 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Severe Multi-Symptom Cough Cold Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE WALGREENS b48d93fe-bb60-493f-8d1a-b2dc864203c4 2025-12-01 Warnings Exact identifier application number: M013 Multi Symptom Severe Cold and Nighttime Severe Cold and Cough ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL WALGREEN CO. 6c4ab613-a587-4ec4-9986-f1d000bc2d23 2025-12-01 Warnings Exact identifier application number: M013 WAG HBP Daytime and Nighttime Cold and Flu ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE WALGREENS CO. ac2f9ce8-e402-4451-a412-e99248a6ecbe 2025-12-01 Warnings Exact identifier application number: M013 Walgreen Day Time NightTime Cold and Flu Relief ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN WALGREENS CO. 5505217a-9679-4668-bdab-5d4553a47c56 2025-12-01 Warnings Exact identifier application number: M013 CAREALL Aspirin ASPIRIN New World Imports, Inc 58a371d4-1f00-4fda-8e08-80610c58505a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Non Aspirin Extra Strength ACETAMINOPHEN New World Imports, Inc da05a1a1-35b4-4787-8c56-12e369f18ff0 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 80a699b9-bf5c-4765-9e20-ccbc7e3ace7a 2025-12-01 Warnings Exact identifier application number: M013 CareALL Acetaminophen Extra Strength ACETAMINOPHEN New World Imports, Inc 66244cdb-2680-4fa8-890d-32aefd490038 2025-12-01 Warnings Exact identifier application number: M013 Family Wellness Childrens Pain Reliever 574 ACETAMINOPHEN Family Dollar Services, Inc. 902c1136-04d2-41f0-81c6-412663cdf378 2025-12-01 Warnings Exact identifier application number: M013 WalgreenChildrens Pain Fever ACETAMINOPHEN WALGREENS CO. 2f757cde-2604-4ca4-b54e-e444f3757cdd 2025-11-26 Warnings Exact identifier application number: M013 Walgreen Childrens Pain plus Fever ACETAMINOPHEN WALGREENS CO. 29ca2855-3c07-435d-a8e1-2997fcedd088 2025-11-26 Warnings Exact identifier application number: M013 Walgreens Childrens Cold plus Cough plus Runny Nose ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE WALGREENS CO. 8714d4e6-3a3b-48c8-8ac1-51b933a2ceac 2025-11-26 Warnings Exact identifier application number: M013 Pain Reliever, 24/7 Life by 7-Eleven ACETAMINOPHEN TABLET, FILM COATED Lil' Drug Store Products, Inc. 44828b89-2563-b233-e063-6294a90ab124 2025-11-26 Warnings Exact identifier application number: M013 MEMBERS MARK ACETAMINOPHEN ACETAMINOPHEN Sam's West Inc 03e831d4-8060-4633-9d02-e77100063fb4 2025-11-26 Warnings Exact identifier application number: M013 Childrens Pain and Fever Dissolve Packs ACETAMINOPHEN WALGREENS CO. ea0f265f-7d64-4731-beda-0bb841dd1ad7 2025-11-25 Warnings Exact identifier application number: M013 Sore Throat Logenzes Sore Throat BENZOCAINE AND MENTHOL ATLANTIC BIOLOGICALS CORP. 71a80e13-bda3-40fb-b4e7-45e9985e707c 2025-11-24 Warnings Exact identifier application number: M013 better living brands childrens fever and pain reliver ACETAMINOPHEN BETTER LIVING BRANDS LLC c13ced61-c491-4fc2-b83f-78c6d9ad8546 2025-11-20 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 69729-055-40 69729005540 1 BOTTLE in 1 CARTON (69729-055-40) / 40 TABLET in 1 BOTTLE 1 bottle 2022-09-07 0000-00-00 No No Current