Home NDC 69197-029 SED-MAX
Product NDC 69197-029
11-digit product format 691970029
Labeler code 69197
Product ID 69197-029_bd14fe1d-1a3f-4854-aab9-dbcd09046365
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500 mg with Caffeine 65mg
Dosage form TABLET, COATED
Route ORAL
Labeler Command Brands, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-11-26
Substance ACETAMINOPHEN; CAFFEINE
Active strength 500; 65 mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 SED-MAX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1 CAFFEINE 65 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307686 Internal RxNorm lookup 1866143 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 69197-029-20 SED-MAX 20 in 1 BOTTLE TABLET, COATED 20 4 69197-029-20 SED-MAX 1 in 1 CARTON TABLET, COATED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69197-029 SED-MAX (ACETAMINOPHEN 500 MG WITH CAFFEINE 65MG) TABLET, COATED [COMMAND BRANDS, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20231020_4920a0e9-6f88-4df0-8657-77c95a3b9617.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 1 of 83 · 1,657 matching rows.
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 69197-029-20 69197002920 1 BOTTLE in 1 CARTON (69197-029-20) / 20 TABLET, COATED in 1 BOTTLE 1 bottle 2014-11-26 0000-00-00 No No Current