FDA.reportPublic FDA data

Tension Headache Relief

Product NDC
72090-004
11-digit product format
720900004
Labeler code
72090
Product ID
72090-004_c6c2e845-ba5c-402d-8526-7d2fd4c03703
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN, CAFFEINE
Dosage form
TABLET
Route
ORAL
Labeler
Pioneer Life Sciences, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-03
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72090-004-022023-10-25C16284748780-1f386c649-e9a7-0266-e053-dadaa90a7c1aTension Headache Relief (Acetaminophen 500mg and caffeine 65mg)
72090-004-022023-01-30C16284748780-1f386c649-e9a7-0266-e053-dadaa90a7c1aTension Headache Relief (Acetaminophen 500mg and caffeine 65mg)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72090-004-02Tension Headache Relief200 in 1 BOTTLETABLET2007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72090-004TENSION HEADACHE RELIEF (ACETAMINOPHEN, CAFFEINE) TABLET [PIONEER LIFE SCIENCES, LLC]6Current NDC, Legacy NDC, 1 package rows20240509_ac9efd62-8fee-b777-e053-2995a90a3783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletPSNac9efd62-8fee-b777-e053-2995a90a37837
307686acetaminophen 500 MG / caffeine 65 MG Oral TabletSCDac9efd62-8fee-b777-e053-2995a90a37837
307686APAP 500 MG / Caffeine 65 MG Oral TabletSYac9efd62-8fee-b777-e053-2995a90a37837

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72090-004-0272090000402200 TABLET in 1 BOTTLE (72090-004-02) 200 tablet2020-08-030000-00-00NoNoCurrent