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

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
IngredientStrength
ACETAMINOPHEN500 mg/1
CAFFEINE65 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307686Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac9efd62-8fee-b777-e053-2995a90a3783Available on FDA.report

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

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 53 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relief Extra StrengthACETAMINOPHENDISCOUNT DRUG MARTe6fee238-0b6f-cb84-e053-2995a90a361b2024-12-05WarningsExact identifier
application number: M013
Menstrual Complete Maximum StrengthACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATEL.N.K. International, Inc.379ef03c-3b6a-40c3-b736-99f0537d26c82024-12-05WarningsExact identifier
application number: M013
Pain Reliever Extra StrengthACETAMINOPHENMarc Glassman, Inc.43bf297f-2832-424f-a013-4bfa1d6c03e62024-12-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.5a68ab98-720c-479a-a60a-4e594add6c092024-12-04WarningsExact identifier
application number: M013
HEB Effervescent Pain ReliefASPIRINH. E. BUTT GROCERY COMPANY03876c71-60ec-3280-e063-6294a90a62dc2024-12-03WarningsExact identifier
application number: M013
Migrafein FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028875c9-4129-ce2c-e063-6294a90a26cc2024-12-03WarningsExact identifier
application number: M013
Neo-Lubrina FuerteACETAMINOPHEN, CAFFEINEOPMX LLC0288a327-fd4b-1991-e063-6294a90ace502024-12-03WarningsExact identifier
application number: M013
CAFIZETAMOL FORTEACETAMINOPHEN, CAFFEINEOPMX LLC028771d3-a514-f7a5-e063-6394a90ac4f32024-12-03WarningsExact identifier
application number: M013
BuscapinaACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEOPMX LLC048c4b03-1cf4-b724-e063-6294a90a1cad2024-12-03WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENTopCo Associates LLCecd6df7e-e7e2-446b-85ef-25971281fe312024-12-03WarningsExact identifier
application number: M013
Market Basket Effervescent Pain ReliefASPIRINDEMOULAS SUPER MARKETS, INC.08133bf0-3c8f-e4d0-e063-6294a90af79a2024-12-03WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINWinCo Foods, LLC4359da13-e851-440b-91b9-6b544bff20d22024-12-03WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINWinCo Foods, LLC5b3e8a78-5357-42ad-811e-b2578b25dc7b2024-12-03WarningsExact identifier
application number: M013
Low Strength Chewable AspirinASPIRINGeri-Care Pharmaceutical Corpcc77b9d1-7874-4ce8-a763-3a0e1c2891de2024-12-03WarningsExact identifier
application number: M013
Good Sense Childrens Pain and FeverACETAMINOPHENL. Perrigo Companyc6b79501-d08b-4430-9545-70da5f5459752024-12-03WarningsExact identifier
application number: M013
AspirinASPIRINChain Drug Marketing Association0e3be5f4-bc1b-4b44-a86a-ace89f6ee5922024-12-02WarningsExact identifier
application number: M013
St. Joseph Chewable Low Dose AspirinASPIRINFoundation Consumer Healthcare LLC248cd302-e380-4837-bdae-9df620b67e8a2024-12-02WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENAAA Pharmaceutical, Inc.2d98e390-4f2a-41cc-b307-3d2f6a3700dd2024-12-02WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEAAA Pharmaceutical, Inc.409b5fcd-5880-4dda-85d8-26aeceb4f8ab2024-12-02WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.c0c31523-c4c5-43c2-8d72-4d1456c720e92024-12-02WarningsExact identifier
application number: M013

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