Home NDC 68163-506 DRX CHOICE
Product NDC 68163-506
11-digit product format 681630506
Labeler code 68163
Product ID 68163-506_377780a5-9495-2c39-e063-6294a90ac8b2
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Caffeine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Raritan Pharmaceuticals Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-16
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 Additional Listing Data#
Finished product Yes
Brand name base DRX CHOICE
Brand name suffix Tension Headache
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 307686 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 68163-506-15 DRX CHOICETension Headache 1 in 1 CARTON TABLET, FILM COATED 1 1 68163-506-15 DRX CHOICETension Headache 15 in 1 BOTTLE TABLET, FILM COATED 15 1
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 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68163-506-15 68163050615 1 BOTTLE in 1 CARTON (68163-506-15) / 15 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2025-05-16 No No Current