Home NDC 69168-001 Tension Headache Relief
Product NDC 69168-001
11-digit product format 691680001
Labeler code 69168
Product ID 69168-001_0801608d-547e-4a42-aaa5-7b2c6a1d7075
Type HUMAN OTC DRUG
Nonproprietary name Tension Headache Relief
Dosage form CAPSULE, COATED
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-22
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 Tension Headache Relief
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 410226 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 69168-001-24 Tension Headache Relief 1 in 1 CARTON CAPSULE, COATED 1 3 69168-001-24 Tension Headache Relief 24 in 1 BOTTLE CAPSULE, COATED 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-001 TENSION HEADACHE RELIEF CAPSULE, COATED [ALLEGIANT HEALTH] 3 Current NDC, Legacy NDC, 2 package rows 20231020_9d348550-060b-410f-8c1e-8f43d00b860e.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 78 of 79 · 1,570 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 69168-001-24 69168000124 1 BOTTLE in 1 CARTON (69168-001-24) / 24 CAPSULE, COATED in 1 BOTTLE 1 bottle 2021-11-22 0000-00-00 No No Current