Tension Headache Relief

Product NDC
84324-002
11-digit product format
843240002
Labeler code
84324
Product ID
84324-002_407cbaec-b2d2-418c-b643-9b9bb883b2c7
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
NUVICARE LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-30
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
Tension Headache Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE65 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, 3G6A5W338E
Rxcui307686

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84324-002-01Tension Headache Relief100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84324-002TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [NUVICARE LLC]2Current NDC, 1 package rows20240821_ea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSNea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e3
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCDea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e3
307686APAP 500 MG / Caffeine 65 MG Oral TabletSYea4e50e9-2c4d-4e58-b2cb-ab23e91fd50e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84324-002-0184324000201100 TABLET in 1 BOTTLE (84324-002-01) 100 tablet2024-07-30NoNoCurrent