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 71 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dye Free Infants Pain and Fever ACETAMINOPHEN WALGREENS 0b1d88d8-56ff-9e9d-e063-6394a90a015c 2024-04-09 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE H E B 4d572228-3141-4539-9c3d-2fd06e94eee3 2024-04-09 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 1b5ff867-5442-4cf8-bd1e-530093cc88f8 2024-04-05 Warnings Exact identifier application number: M013 Excedrin Extra Strength Pain Reliever ACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINE Haleon US Holdings LLC 0faa3592-4d56-4645-9a0e-066e0bdfebb6 2024-04-05 Warnings Exact identifier application number: M013 Pain Relief Childrens Dye Free ACETAMINOPHEN H E B 3f9beeeb-5e27-4b81-a647-20e65f0e9fc9 2024-04-03 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN H E B edb321dd-e5cb-4031-a8a8-efce9e86fe16 2024-04-03 Warnings Exact identifier application number: M013 Childrens Pain Relief ACETAMINOPHEN H E B a0c0277e-50aa-4328-8f93-ab20c6176b2b 2024-04-03 Warnings Exact identifier application number: M013 Regular Strength Enteric coated aspirin ASPIRIN Bryant Ranch Prepack bda805ab-7f37-405d-a144-4e06ad9a29a1 2024-04-03 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Family Dollar (FAMILY WELLNESS) 650cb15e-c448-4df3-b0f8-4398be05d841 2024-03-27 Warnings Exact identifier application number: M013 Good Sense Effervescent Pain Relief ASPIRIN Perrigo Direct, Inc. 103027a7-2f0e-8d8c-e063-6294a90aedc7 2024-03-26 Warnings Exact identifier application number: M013 rugby infants acetaminophen ACETAMINOPHEN Rugby Laboratories 8aa9ac68-ca61-4163-a876-52034138c1ea 2024-03-25 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 08a18481-f029-f01f-e063-6294a90aac65 2024-03-21 Warnings Exact identifier application number: M013 Equate Pain Reliever Acetaminophen for Adults 250 mg ACETAMINOPHEN Walmart Inc 0d106fa2-2a77-deb2-e063-6394a90a2dac 2024-03-21 Warnings Exact identifier application number: M013 Pain Relief Extra Strength ACETAMINOPHEN EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 872c5220-a379-4dc1-b99c-f11ebb82db35 2024-03-19 Warnings Exact identifier application number: M013 Pain Reliever PM Extra Strength ACETAMINOPHEN, DIPHENHYDRAMINE HCL EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) 79886972-47a4-44c5-a131-1a691a328103 2024-03-19 Warnings Exact identifier application number: M013 Headache Relief Extra Strength ACETAMINOPHEN, ASPIRIN, CAFFEINE Dolgencorp, Inc. (DOLLAR GENERAL & REXALL) 5ffcc78d-9163-4cb4-8811-ae9f0142806a 2024-03-18 Warnings Exact identifier application number: M013 ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER ASPIRIN LOW DOSE CHEWABLE ORANGE PAIN RELIEVER HF Acquisition Co LLC, DBA HealthFirst 13e621dc-b2b4-98fd-e063-6394a90acc75 2024-03-17 Warnings Exact identifier application number: M013 Childrens Pain and Fever ACETAMINOPHEN CVS PHARMACY, INC 097a9c98-a092-400d-9600-6797b0b9a50c 2024-03-15 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets and Excedrin Tension Headache ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE, AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC 978a9d27-6d41-42cb-a193-11314923d2ac 2024-03-14 Warnings Exact identifier application number: M013 Excedrin PM Triple Action Caplets ACETAMINOPHEN, ASPIRIN (NSAID) AND DIPHENHYDRAMINE CITRATE Haleon US Holdings LLC b3812d27-40af-40d7-864a-dfa4ae34cb9e 2024-03-14 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 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