Home NDC 69729-055-40 SEDAL3X
Product NDC 69729-055
Requested package NDC 69729-055-40
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 · 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 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 69729-055 69729-055-40 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 69729-055 69729-055-40 I Inactivated by FDA excluded / ndc_excluded.zip 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 45 of 79 · 1,561 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Acetaminophen ACETAMINOPHEN A-S Medication Solutions c4f0f591-8501-4c6d-bf8e-ca3068ff65b5 2025-04-24 Warnings Exact identifier application number: M013 Extra Strength No-Pain ACETAMINOPHEN Safrel Pharmaceuticals, LLC. 873f01dd-0701-5fd3-e053-2a95a90a6463 2025-04-23 Warnings Exact identifier application number: M013 Pain Reliever ACETAMINOPHEN Chain Drug Consortium 60d4b392-6ed0-4115-8154-24eaf72504a5 2025-04-16 Warnings Exact identifier application number: M013 Premsyn pms Premenstrual Pain Relief ACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATE Focus Consumer Healthcare, LLC 5b6f6260-69ae-cfeb-e053-2a91aa0a6b49 2025-04-14 Warnings Exact identifier application number: M013 BackAid Max ACETAMINOPHEN, PAMABROM Kobayashi Healthcare International, Inc. fb9a5647-b7c9-4820-b148-91060e34cb83 2025-04-14 Warnings Exact identifier application number: M013 RIGHT REMEDIES LOW DOSE Aspirin 81mg ASPIRIN Strive Pharmaceuticals Inc. 322c0e50-cf75-51ab-e063-6294a90a9235 2025-04-14 Warnings Exact identifier application number: M013 Bayer Aspirin Regimen Chewable Low Dose Aspirin Orange ASPIRIN Bayer HealthCare LLC. 0c6ae05f-760f-34d1-e054-00144ff88e88 2025-04-11 Warnings Exact identifier application number: M013 Arthriten Inflammatory Pain Formula ACETAMINOPHEN, ASPIRIN, CAFFEINE Kobayashi Healthcare International, Inc c280ca89-4fb5-4050-90ee-d706a550a1ef 2025-04-11 Warnings Exact identifier application number: M013 Bayer Back and Body Extra Strength ASPIRIN,CAFFEINE Bayer HealthCare LLC. 0c77c484-6caf-12ca-e054-00144ff88e88 2025-04-10 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN NuCare Pharmaceuticals, Inc. 324937c3-c558-bc79-e063-6294a90acc8e 2025-04-08 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN 500MG CVS Pharmacy, Inc. 1fde6487-6682-99a3-e063-6294a90a3670 2025-04-04 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN Bryant Ranch Prepack bdc466c9-d9ae-4293-b7ea-46fb517661c6 2025-04-01 Warnings Exact identifier application number: M013 Adult Low Dose Enteric Coated Aspirin ASPIRIN Geri-Care Pharmaceutical Corp e327a52a-0e31-44b7-9823-7f60d070ae52 2025-04-01 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN Proficient Rx LP 9af5ccc8-aac0-4339-a9f6-58fdc9b91c57 2025-04-01 Warnings Exact identifier application number: M013 ASPIRIN 325 MG EC ASPIRIN Bryant Ranch Prepack 9d0449d2-c0c6-4e74-931b-35dc62584028 2025-03-31 Warnings Exact identifier application number: M013 Aspirin 81 mg ASPIRIN Bryant Ranch Prepack cce1e8bd-63c8-403a-bc32-e6788493f604 2025-03-31 Warnings Exact identifier application number: M013 Adwe Feverx Acetaminophen Caplets, 500 mg Extra Strength ACETAMINOPHEN Aurex Laboratories Limited Liability Company 948c5826-6f35-484d-bb3f-cecf6a4b5c13 2025-03-31 Warnings Exact identifier application number: M013 Infants Pain and Fever ACETAMINOPHEN WALGREENS 281a530b-c759-50eb-e063-6394a90abb4f 2025-03-28 Warnings Exact identifier application number: M013 Pain Reliever PM ACETAMINOPHEN, DIPHENHYDRAMINE HCL WR Group, Inc. 8281771c-485c-42a9-9a1c-9a7a4298c5b8 2025-03-28 Warnings Exact identifier application number: M013 Acetaminophen Regular strength ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 4181efc2-d183-410c-b647-233444c57e32 2025-03-20 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